PharmaMar Group presents financial results for first half 2026

On July 29, 2026 PharmaMar Group (MSE: PHM) reported the close of first half of the year with an 18% increase in recurring revenue, defined as the sum of net sales and royalties received from our partners, reaching €85.1 million, despite the fact that the commercial launch of Zepzelca (lurbinectedin) in Europe had not yet commenced as of the end of the period.

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As of June 30th, 2026, net sales increased by 1.3% to €46.4 million. This growth was driven by lurbinectedin revenue in Europe, particularly through compassionate use programs, mainly in France, where revenue increased by 39.5% to €21.6 million. Sales of active pharmaceutical ingredients to our partners, for both lurbinectedin and Yondelis (trabectedin), rose 16.2% to €15.9 million.

At the end of the first half of 2026, oncology royalty income increased by 46.3% year-on-year to €38.7 million. This growth was primarily driven by a 50.5% increase in royalties received from our partners’ sales of lurbinectedin, which reached €31.6 million[1]. Meanwhile, royalties received from trabectedin sales in the United States increased by 30.1% to €7.1 million during the first six months of the year.

Non-recurring revenue totaled €7.4 million as of June 30th, 2026, compared with €23.0 million in the same period of the previous year. This difference is mainly explained by the fact that non-recurring revenue in the first half of 2025 included a €22 million upfront payment from Merck related to the licensing of lurbinectedin in Japan.

As a result, PharmaMar Group’s total revenue reached €92.5 million at the end of the first half of 2026, compared with €95.3 million as of June 30th, 2025. Consequently, the strong growth of the recurring business during the period largely offset the impact of the upfront payment recognized in the first half of the previous year.

During the first six months of 2026, PharmaMar Group’s R&D investment amounted to €47.3 million, compared with €47.5 million recorded as of June 30th, 2025.

Of the total R&D investment, the oncology segment accounted for €45.3 million, compared with €44.8 million in June 2025. Investment increased by 1% year-on-year, mainly due to spending on the Phase III SaLuDo trial evaluating lurbinectedin in combination with doxorubicin as a first-line treatment for leiomyosarcoma, for which patient recruitment was completed during the period, as well as increased investment in the early-stage compounds PM54 and PM534.

As of June 30th, 2026, PharmaMar Group’s EBITDA amounted to €3.6 million, compared with €25.1 million in the same period of the previous year. The difference between the two periods is attributable both to the income generated by the lurbinectedin licensing agreement in Japan and to the recognition in 2025 of €14.7 million in grants awarded to Sylentis under the European IPCEI program.

As a result of the above, PharmaMar Group reported net profit of €0.6 million, compared with €19.4 million in the first half of the previous year.

As of June 30th, 2026, PharmaMar Group’s cash and cash equivalents increased by €1.7 million to €169.5 million. At the same time, total financial debt decreased by €3.5 million to €43.0 million. As a result, the Group’s net cash position increased by €5.2 million to €126.4 million at the end of the period.

PharmaMar will host a conference call for analysts and investors on July 30th, 2026, at 13:00 CET. To join the conference call, participants are encouraged to register via the following link to receive dial-in details and a personalized PIN:

To access the call without prior registration, please use one of the following numbers:

• Spain: +34 91 901 16 44
• United States/Canada: +1 646 664 1960
• Other countries: +44 20 3936 2999

Participant access code: 442855

In addition, the presentation can be followed live through the following webcast link.

(Press release, PharmaMar, JUL 29, 2026, View Source [SID1234669495])

Biodexa Initiates Support Activities for FAP Patients and Treatment Centers in France

On July 29, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has held its first round table meeting in Paris, France as part of expanding its support for Familial Adenomatous Polyposis (FAP) patients and prescribers. The sharing of experience and expertise amongst patients, patient advocacy groups and clinicians is informing Biodexa’s goal of improving outcomes and quality of life for FAP patients. These activities will augment Biodexa previous step of making eRapa available for FAP patients via an Early Access Program and Named Patient prescribing. A global initiative which gives clinicians who treat FAP patients the opportunity to prescribe this investigational medicine outside of a clinical trial for the first time.

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Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "We are delighted to be expanding our support for the FAP community and are committed to improving the lives of patients. We are proud to be support clinicians and patients in this way in addition to making eRapa available to clinicians for whom there are no currently approved therapeutic options."

About Familial Adenomatous Polyposis

FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 patients randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

(Press release, Biodexa Pharmaceuticals, JUL 29, 2026, View Source [SID1234669513])

Teva Delivers Strong Q2 Results and Raises Outlook for All Three Key Innovative Brands, Reflecting Continued Execution of Its Pivot to Growth Strategy

On July 29, 2026 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended June 30, 2026.

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Mr. Richard Francis, Teva’s President and CEO, said: "Our second quarter reflects continued execution of our Pivot to Growth strategy. During the quarter, and into July, we advanced several value-creating assets, including two additional indications for duvakitug, demonstrating its pipeline-in-a-product potential, the acquisition and NDA submission of ecopipam (EBS-101), continued progress for olanzapine LAI, and expansion of our biosimilars pipeline through strategic collaborations."

Mr. Francis added, "Our key Innovative brands collectively generated over $1 billion in revenues, continuing to transform Teva’s portfolio mix and financial profile. The breadth of these milestones underscores the increasingly diversified nature of Teva’s growth profile. We are strengthening our neuroscience and immunology pipeline, expanding access through biosimilars, and continuing to modernize the business to support sustainable, innovation-driven growth and long-term value creation for patients and shareholders."

Pivot to Growth Strategy

In the second quarter of 2026, we continued to execute on the four key pillars of our "Pivot to Growth" strategy, announced in May 2023:

Delivering on our growth engines – Teva’s key innovative brands, AUSTEDO, AJOVY and UZEDY, collectively grew 43% YoY in LC in Q2 2026 to over $1 billion in revenues, continuing to transform the Company’s portfolio mix and financial profile. Each individual brand grew at least 40% YoY in LC in the quarter. Based on year-to-date performance, Teva is raising its outlook for all three key innovative brands.
Stepping up innovation – We advanced multiple assets in our late-stage innovative pipeline focused on well characterized compounds and validated disease targets. Teva submitted an NDA for ecopipam (EBS-101), a first-in-class investigational therapy for pediatric Tourette syndrome, acquired with Emalex. In May 2026, the EMA accepted the MAA for olanzapine LAI (TEV-’749). We announced encouraging Phase 1b results for TEV-’408 (anti-IL-15) in vitiligo and expect to initiate a vitiligo Phase 2 trial in Q4 2026. For duvakitug (anti-TL1A, developed in collaboration with Sanofi) we announced plans to initiate studies in two additional indications – hidradenitis suppurativa (HS) and fibrostenotic Crohn’s Disease (FSCD) – demonstrating its pipeline-in-a-product potential. Recruitment is on track for our Phase 3 studies for duvakitug in ulcerative colitis (UC) and Crohn’s disease (CD).
Sustaining our generics powerhouse – Teva continues to enhance its biosimilars portfolio, including the launch of AHZANTIVE in Europe and the collaboration agreement with Polpharma Biologics for a proposed biosimilar to Ocrevus covering both intravenous and subcutaneous formulations. On track with operational readiness for 3 additional biosimilars in 2027, building a robust portfolio of 18 biosimilars.
Focusing our business – We are actively transforming and modernizing our business through Teva Transformation programs and expect to realize two-thirds of the targeted savings in 2026, while maintaining disciplined capital allocation. During the quarter, Fitch Rating Agency raised the Company’s corporate credit rating to Investment Grade BBB-, recognizing Teva’s significantly improved balance sheet and successful execution of its Pivot to Growth strategy.
Second Quarter 2026 Consolidated Results

Revenues in the second quarter of 2026 were $4,142 million, a decrease of 1% in U.S. dollars, or 3% in local currency terms compared to the second quarter of 2025. This decrease was mainly due to lower revenues from generic products, primarily lenalidomide capsules (a generic version of Revlimid) in our U.S. segment, partially offset by higher revenues from our key innovative products, primarily AUSTEDO and AJOVY.

Exchange rate movements in the second quarter of 2026 including hedging effects, positively impacted revenues by $85 million, compared to the second quarter of 2025.

Gross profit in the second quarter of 2026 was $2,153 million, an increase of 2% compared to $2,102 million in the second quarter of 2025. Gross profit margin was 52.0% in the second quarter of 2026, compared to 50.3% in the second quarter of 2025. This increase was mainly due to higher revenues from AUSTEDO, partially offset by lower revenues from generic products in our United States segment, primarily lenalidomide capsules (a generic version of Revlimid). Non-GAAP gross profit was $2,293 million in the second quarter of 2026, an increase of 1% compared to $2,278 million in the second quarter of 2025. Non-GAAP gross profit margin was 55.4% in the second quarter of 2026, compared to 54.6% in the second quarter of 2025. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products, primarily higher revenues from AUSTEDO and AJOVY, partially offset by lower revenues from generic products, primarily lenalidomide capsules (a generic version of Revlimid).

Research and Development (R&D) expenses, net in the second quarter of 2026, were $970 million, an increase of 298% compared to $244 million in the second quarter of 2025, primarily due to our acquisition of Emalex Biosciences and its primary asset, ecopipam (EBS-101). This increase was partially offset by a decrease in our expenses related to our generic projects. Our R&D expenses, net in the second quarters of 2026 and 2025, were also impacted by reimbursements and cost sharing from our strategic partnerships and collaborations entered into in recent years.

Selling and Marketing (S&M) expenses in the second quarter of 2026 were $717 million, an increase of 10% compared to the second quarter of 2025. This increase was mainly due to promotional activities related to our key innovative products, primarily AUSTEDO, as well as a negative impact from exchange rate fluctuations.

General and Administrative (G&A) expenses in the second quarter of 2026 were $317 million, an increase of 4% compared to the second quarter of 2025.

Operating loss was $231 million in the second quarter of 2026, compared to an operating income of $455 million in the second quarter of 2025. Operating loss as a percentage of revenues was 5.6% in the second quarter of 2026, compared to operating income as a percentage of revenues of 10.9% in the second quarter of 2025. This change was mainly due to higher R&D expenses primarily related to the acquisition of Emalex and its primary asset ecopipam (EBS-101). Non-GAAP operating income in the second quarter of 2026 was $375 million representing a non-GAAP operating margin of 9.0% compared to $1,133 million representing 27.1%, respectively, in the second quarter of 2025. This decrease in non-GAAP operating margin in the second quarter of 2026 was mainly due to higher R&D expenses primarily related to the acquisition of ecopipam (EBS-101), as discussed above.

Exchange rate movements in the second quarter of 2026, net of hedging effects, had a positive impact of $26 million on our operating loss and non-GAAP operating income compared to the second quarter of 2025.

Financial expenses, net in the second quarter of 2026, were $224 million, mainly comprised of net interest expenses of $195 million. In the second quarter of 2025, financial expenses, net were $252 million, mainly comprised of net interest expenses of $203 million.

In the second quarter of 2026, we recognized a tax expense of $121 million, on pre-tax loss of $455 million. In the second quarter of 2025, we recognized a tax benefit of $78 million, on pre-tax income of $203 million.

Our tax rate in the second quarter of 2026 was negative 26.5%, compared to negative 38.4% in the second quarter of 2025. Non-GAAP tax rate in the second quarter of 2026 was 86.7%, compared to 16.4% in the second quarter of 2025. Our tax rate and non-GAAP tax rate in the second quarter of 2026 were mainly affected by an unfavorable tax impact of a non-deductible acquired IPR&D charge related to the acquisition of Emalex and its primary asset ecopipam (EBS-101), the generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate and other infrequent or non-recurring items. Our tax rate and non-GAAP tax rate in the second quarter of 2025 were mainly affected by releases of uncertain tax positions, foreign exchange impact on deferred tax positions and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities.

Considering the above, we expect our annual non-GAAP tax rate for 2026 to be between 20%-23%, higher than our non-GAAP tax rate for 2025, which was 15.8%.

Net loss attributable to Teva and loss per share in the second quarter of 2026 were $576 million and $0.49, respectively, compared to net income attributable to Teva and earning per share of $282 million and $0.24, respectively, in the second quarter of 2025. This change was mainly due to the change in operating loss as well as higher income taxes, primarily due to the acquisition of Emalex and its primary asset, ecopipam (EBS-101), as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the second quarter of 2026 were $21 million and $0.02, respectively, compared to $769 million and $0.66, respectively, in the second quarter of 2025.

Adjusted EBITDA was $474 million in the second quarter of 2026, a decrease of 62%, compared to $1,233 million in the second quarter of 2025.

As of June 30, 2026 and 2025, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,191 million shares and 1,179 million shares, respectively.

Non-GAAP information: non-GAAP adjustments in the second quarter of 2026 were $597 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the second quarter of 2026 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $139 million, of which $129 million is included in cost of sales and the remaining $9 million in S&M expenses;
Legal settlements and loss contingencies of $230 million;
Restructuring expenses of $38 million;
Impairment of long-lived assets of $113 million;
Contingent consideration expenses of $17 million;
Equity compensation expenses of $40 million;
Financial expenses of $8 million;
Other non-GAAP items of $29 million; and
Corresponding tax effects and unusual tax items of $17 million.
We believe that excluding such items facilitates investors’ understanding of our business including underlying trends, thereby improving the comparability of our business performance results between reporting periods.

For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operating activities during the second quarter of 2026 was $411 million compared to $227 million in the second quarter of 2025. The higher cash flow generated from operating activities in the second quarter of 2026 was mainly due to lower contingent consideration payments and lower tax payments, partially offset by higher legal settlement payments.

During the second quarter of 2026, we generated free cash flow of $622 million, which we define as comprising: $411 million in cash flow generated from operating activities, $311 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $4 million of proceeds from the sale of businesses and long-lived assets, partially offset by $104 million in cash used for capital investments. During the second quarter of 2025, we generated free cash flow of $476 million, which we define as comprising $227 million in cash flow generated from operating activities, $336 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $9 million of proceeds from the sale of businesses and long-lived assets, partially offset by $96 million in cash used for capital investments. The increase in the second quarter of 2026 resulted mainly from higher cash flow generated from operating activities, as discussed above.

As of June 30, 2026, our debt was $16,593 million, compared to $16,807 million as of December 31, 2025. This decrease was mainly due to $201 million of exchange rate fluctuations. The portion of total debt classified as short-term as of June 30, 2026, was 27% compared to 11% as of December 31, 2025. Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 68% as of June 30, 2026 and December 31, 2025. Our average debt maturity was approximately 5.1 years as of June 30, 2026, compared to 5.6 years as of December 31, 2025.

Segment Results for the second quarter of 2026

United States Segment

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. This shift allows the United States segment to continue to manage its entire product portfolio in the region, while strengthening focus on its biopharmaceutical business, growth engines and innovation. As a result, from that date, Anda is reported as part of the Company’s Other Activities. Prior period amounts were recast to reflect this change.

The following table presents revenues, expenses and profit for our United States segment for the three months ended June 30, 2026 and 2025:


Three months ended June 30,
2026
2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,702 100 % $ 1,786 100 %
Cost of sales 499 29.3 % 574 32.2 %
Gross profit 1,203 70.7 % 1,211 67.8 %
R&D expenses* 883 51.9 % 152 8.5 %
S&M expenses 294 17.3 % 250 14.0 %
G&A expenses 107 6.3 % 111 6.2 %
Other (5 ) § § §
Segment profit (loss)** $ (76 ) (4.5 %) $ 699 39.1 %

* Mainly related to the acquisition of Emalex and its primary asset ecopipam (EBS-101) in the United States segment.
** Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our United States segment in the second quarter of 2026 were $1,702 million, a decrease of 5% compared to the second quarter of 2025, mainly due to lower revenues from generic products, primarily lenalidomide capsules (a generic version of Revlimid), partially offset by higher revenues from our key innovative products, primarily AUSTEDO.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended June 30, 2026 and 2025:

Three months ended
June 30, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)

Generic products (including biosimilars) $ 660 $ 961 (31%)
AJOVY 116 63 83%
AUSTEDO 676 495 37%
BENDEKA and TREANDA 28 40 (30%)
COPAXONE 61 62 (2%)
UZEDY 77 54 43%
Other 84 111 (25%)
Total $ 1,702 $ 1,786 (5%)

Generic products (including biosimilar products) revenues in our United States segment in the second quarter of 2026 were $660 million, a decrease of 31% compared to the second quarter of 2025. This decrease was mainly driven by lower revenues from lenalidomide capsules (a generic version of Revlimid) due to increased generic competition in the U.S., partially offset by higher revenues from our portfolio of biosimilar products.

Among the most significant generic products we sold in the United States in the second quarter of 2026 were Truxima (a biosimilar to Rituxan), epinephrine injectable solution (a generic equivalent of EpiPen and EpiPen Jr) and SIMLANDI (a biosimilar to Humira). In the second quarter of 2026, our total prescriptions were approximately 237 million (based on trailing twelve months), representing 6.1% of total U.S. generic prescriptions, compared to approximately 266 million (based on trailing twelve months), representing 6.9% of total U.S. generic prescriptions in the second quarter of 2025, all according to IQVIA data.

AJOVY revenues in our United States segment in the second quarter of 2026 were $116 million, an increase of 83% compared to the second quarter of 2025, mainly due to a reduction in sales allowance as well as growth in volume. In the second quarter of 2026, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.5% out of the subcutaneous injectable anti-CGRP class, compared to 31.0% in the second quarter of 2025.

AUSTEDO revenues (which include AUSTEDO XR) in our United States segment in the second quarter of 2026 were $676 million, an increase of 37%, compared to the second quarter of 2025. This increase was mainly due to growth in volume and a favorable business mix including improved net-price realization.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the twice-daily AUSTEDO.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the second quarter of 2026 were $77 million, an increase of 43% compared to the second quarter of 2025, mainly due to growth in volume, partially offset by higher sales allowances.

BENDEKA and TREANDA combined revenues in our United States segment in the second quarter of 2026 were $28 million, a decrease of 30% compared to the second quarter of 2025, mainly due to competition from alternative therapies, as well as from branded and generic bendamustine products.

COPAXONE revenues in our United States segment in the second quarter of 2026 were $61 million, a decrease of 2% compared to the second quarter of 2025, mainly due to lower volumes, partially offset by a reduction in sales allowance.

United States Gross Profit

Gross profit from our United States segment in the second quarter of 2026 was $1,203 million, a decrease of 1%, compared to the second quarter of 2025.

Gross profit margin for our United States segment in the second quarter of 2026 increased to 70.7%, compared to 67.8% in the second quarter of 2025. This increase was mainly due to a favorable mix of products, primarily due to higher revenues from our key innovative products, largely AUSTEDO, partially offset by lower revenues from lenalidomide capsules (a generic version of Revlimid).

United States Profit

Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Loss from our United States segment in the second quarter of 2026 was $76 million, compared to a profit of $699 million in the second quarter of 2025. This change was mainly due to higher R&D expenses, primarily related to the acquisition of Emalex and its primary asset ecopipam (EBS-101).

Europe Segment

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended June 30, 2026 and 2025:

Three months ended June 30,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,263 100 % $ 1,298 100 %
Cost of sales 559 44.3 % 581 44.8 %
Gross profit 704 55.7 % 717 55.2 %
R&D expenses 52 4.1 % 59 4.6 %
S&M expenses 222 17.6 % 228 17.5 %
G&A expenses 66 5.2 % 66 5.1 %
Other* (3 ) § § §
Segment profit* $ 367 29.1 % $ 364 28.0 %

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our Europe segment in the second quarter of 2026 were $1,263 million, a decrease of 3% compared to the second quarter of 2025. In local currency terms, revenues decreased by 8% compared to the second quarter of 2025, mainly due to lower proceeds from the sale of certain product rights, and lower revenues from generic products. In the second quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $63 million, including hedging effects, compared to the second quarter of 2025. Revenues in the second quarter of 2026, included $3 million from a positive hedging impact, while revenues in the second quarter of 2025 included $25 million from a negative hedging impact, which is included in "Other" in the table below.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended June 30, 2026 and 2025:

Three months ended
June 30, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 1,024 $ 1,040 (2%)
AJOVY 78 71 10%
COPAXONE 49 50 (2%)
Respiratory products 58 55 6%
Other* 54 81 (34%)
Total $ 1,263 $ 1,298 (3%)
* Other revenues in the second quarter of 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the second quarter of 2026, were $1,024 million, a decrease of 2% compared to the second quarter of 2025. In local currency terms, revenues decreased by 4%, mainly due to lower sales of generic products and seasonal OTC products, partially offset by higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the second quarter of 2026 were $78 million, an increase of 10%, compared to the second quarter of 2025. In local currency terms revenues increased by 7% due to growth in volume. COPAXONE revenues in our Europe segment in the second quarter of 2026 were $49 million, a decrease of 2% compared to the second quarter of 2025. In local currency terms revenues decreased by 5%, mainly due to price reductions and lower volumes resulting from the availability of alternative therapies, partially offset by a decrease in sales allowance due to a non-recurring item. Respiratory products revenues in our Europe segment in the second quarter of 2026 were $58 million, an increase of 6% compared to the second quarter of 2025. In local currency terms, revenues increased by 3%, mainly due to higher volumes as a result of increased supply.

Europe Gross Profit

Gross profit from our Europe segment in the second quarter of 2026 was $704 million, a decrease of 2% compared to the second quarter of 2025. Gross profit margin for our Europe segment in the second quarter of 2026 increased to 55.7%, compared to 55.2% in the second quarter of 2025. This increase was mainly due to a positive impact from hedging activities, partially offset by lower proceeds from the sale of certain product rights in the second quarter of 2026.

Europe Profit

Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the second quarter of 2026 was $367 million, an increase of 1%, compared to the second quarter of 2025.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2026 and 2025:

Three months ended June 30,
2026 2025
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 550 100 % $ 495 100 %
Cost of sales 266 48.3 % 251 50.8 %
Gross profit 284 51.7 % 243 49.2 %
R&D expenses 26 4.8 % 24 4.9 %
S&M expenses 128 23.3 % 114 23.0 %
G&A expenses 38 6.9 % 32 6.6 %
Other (8 ) (1.4 %) (1 ) §
Segment profit* $ 99 18.0 % $ 74 14.9 %

* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our International Markets segment in the second quarter of 2026 were $550 million, an increase of 11% compared to the second quarter of 2025. In local currency terms, revenues increased by 7% compared to the second quarter of 2025, mainly due to higher revenues from our key innovative products AJOVY and AUSTEDO, primarily in China.

In the second quarter of 2026, revenues were positively impacted by exchange rate fluctuations of $19 million, net of hedging effects, compared to the second quarter of 2025. Revenues in the second quarter of 2026 included $11 million from a negative hedging impact, compared to a negative hedging impact of $8 million in the second quarter of 2025, which are included in "Other" in the table below. The following table presents revenues for our International Markets segment by major products and activities for the three months ended June 30, 2026 and 2025:

Three months ended
June 30, Percentage
Change
2026 2025 2026-2025
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 419 $ 410 2%
AJOVY 49 20 146%
AUSTEDO 20 3 571%
COPAXONE 8 7 7%
Other* 55 55 (1%)
Total $ 550 $ 495 11%

*Other revenues in the second quarter of 2025 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment in the second quarter of 2026 were $419 million, an increase of 2% compared to the second quarter of 2025. In local currency terms, revenues decreased by 1%.

AJOVY revenues in our International Markets segment in the second quarter of 2026 were $49 million, an increase of 146% compared to the second quarter of 2025. In local currency terms, revenues increased by 141%, mainly due to milestone payments received in China, as well as growth in other markets. In April 2026, we announced a strategic partnership for the marketing and distribution of AJOVY in China with Nuerogen (Zhuhai) Pharmaceutical Company Ltd.

AUSTEDO revenues in our International Markets segment in the second quarter of 2026 were $20 million, compared to $3 million in the second quarter of 2025. This increase was mainly due to timing of shipments, as well as growth in China.

COPAXONE revenues in our International Markets segment in the second quarter of 2026 were $8 million, an increase of 7% compared to the second quarter of 2025.

International Markets Gross Profit

Gross profit from our International Markets segment in the second quarter of 2026 was $284 million, an increase of 17% compared to the second quarter of 2025.

Gross profit margin for our International Markets segment in the second quarter of 2026 increased to 51.7%, compared to 49.2% in the second quarter of 2025. This increase was mainly due to higher revenues from AJOVY and AUSTEDO as discussed above.

International Markets Profit

Profit from our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the second quarter of 2026 was $99 million, an increase of 34%, compared to the second quarter of 2025. This increase was mainly due to higher revenues, as discussed above.

Other Activities

We have other sources of revenues, primarily our distribution business in the United States through Anda, the sale of APIs to third parties, an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis and certain contract manufacturing services. Our Other Activities are not included in our United States, Europe or International Markets segments described above.

In alignment with our Pivot to Growth strategy, commencing January 1, 2026, Anda is no longer reported under our United States segment. As a result, from that date, Anda is reported as part of our Other Activities. Prior period amounts were recast to reflect this change.

In 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy, and Teva is conducting a sales process for this matter. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be completed at all.

Our revenues from Other Activities in the second quarter of 2026 were $627 million, an increase of 5% in both U.S. dollars and local currency terms, compared to the second quarter of 2025.

Anda revenues from third-party products in the second quarter of 2026 were $413 million, an increase of 13%, compared to the second quarter of 2025, mainly due to higher volumes. Anda, our distribution business in the United States, operates independently and distributes generic and innovative medicines and OTC pharmaceutical products from various manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda competes in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

API sales to third parties in the second quarter of 2026 were $118 million, a decrease of 12% in both U.S. dollars and local currency terms, compared to the second quarter of 2025. This decrease was mainly due to lower demand resulting from market dynamics and price reductions.

Revenues from additional other activities, mainly from Medis and certain contract manufacturing services, in the second quarter of 2026 were $95 million, a decrease of 3% in U.S. dollars, or 5% in local currency terms compared to the second quarter of 2025.

2026 Financial Outlook

$ billions, except diluted EPS or as noted April 2026
(Including Emalex) July 29 Outlook
(Including Emalex) Emalex impact
Revenues 16.4 – 16.8 $16.5 – $16.85B
AUSTEDO ($m) 2,400 – 2,550 2,450 – 2,600
AJOVY ($m) 750 – 790 850 – 870
UZEDY ($m) 250 – 280 270 – 290
Operating Income* 3.8 – 4.0 3.8 – 4.0 (0.77)
Adjusted EBITDA* 4.23 – 4.53 4.23 – 4.53 (0.77)
Finance Expenses* ~$0.8B ~$0.8B
Tax Rate* 20% – 23% 20% – 23% (+400 bps to ETR)
Diluted EPS* ($) 1.91 – 2.11 1.91 – 2.11 (0.66)
Free Cash Flow* 2.0 – 2.4 2.0 – 2.4
CAPEX 0.5 0.5
Foreign Exchange Volatile swings in FX can negatively impact revenue and income

*Certain items above are non-GAAP financial measures. For more information, see "Non-GAAP Financial Measures" below. Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, July 29, 2026 at 8:00 a.m. ET to discuss its second quarter 2026 financial results and overall business environment.
A question & answer session will follow.
In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin.
A live webcast of the call will be available on Teva’s website at: www.tevapharm.com
Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

(Press release, Teva, JUL 29, 2026, View Source [SID1234669496])

Incyte Reports Second Quarter 2026 Financial Results and Provides Business Updates

On July 28, 2026 Incyte (Nasdaq:INCY) reported financial results for the second quarter of 2026 and provided a business update.

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"Our second quarter was marked by broad-based sales growth, continued pipeline progress and strategic business development," said Bill Meury, Chief Executive Officer, Incyte. "Every marketed product contributed to growth, reflecting the strength of our commercial portfolio and execution. We also recently strengthened our Hematology franchise through the acquisition of latarcibart, a potentially transformative medicine for von Willebrand disease currently in Phase 3 development. With ten data readouts expected in the second half of 2026, alongside product launches through early next year, we are well positioned for our next phase of growth."

Second Quarter 2026 Results

•Total revenue: Total revenue was $1.67 billion, an increase of 38% compared to the second quarter of 2025,* primarily driven by an increase in total net sales across marketed products.
•Total net sales: Total net sales were $1.49 billion, an increase of 40% compared to the second quarter of 2025.* The increase was driven by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura (ruxolitinib) cream, and increased demand across marketed products, including continued demand for Jakafi (ruxolitinib) across all indications, Opzelura in atopic dermatitis (AD) and vitiligo, Niktimvo (axatilimab-csfr) in chronic graft versus host disease (GVHD), Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab) in follicular lymphoma (FL) and Zynyz (retifanlimab-dlwr) in squamous cell carcinoma of the anal canal (SCAC).
•Cost of sales: GAAP and non-GAAP cost of sales were $105.0 million and $98.6 million, respectively, representing 7% of total net sales.
•Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $517.0 million and $478.8 million, an increase of 4% and 5%, respectively, compared to the prior year period.
•Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $351.7 million and $323.6 million, an increase of 6% for each, respectively, compared to the prior year period.

•Cash, cash equivalents and marketable securities position: As of June 30, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $4.5 billion and $3.6 billion, respectively.
Opzelura Financial Impact Related to Agreement with CMS
As a result of the agreement with CMS,* the total estimated incremental impact on Opzelura net sales for the full year 2026 is $300 – $310 million which includes the reversal of previously established accrual balances through the first quarter of 2026 and effects of an improved gross-to-net (GTN) profile on a go-forward basis as summarized in the table below.
Opzelura Net Sales1
Total estimated incremental impact on Opzelura net sales for the full year 2026 $300 – $310 million
One-time, non-cash benefit of the reversal of previously established accrued balances through the first quarter of 2026 ending March 31, 2026 $246 million
Impact on second quarter of 2026 net sales resulting in improved GTN $15 million
Estimated impact on third and fourth quarters of 2026 net sales from improved GTN $40 – $50 million

1Totals may not add due to rounding.
2026 Financial Guidance
Incyte is raising its full year 2026 total net sales guidance to $5,130 – $5,260 million, reflecting the impact of the agreement with CMS related to the Opzelura line extension,* as well as the continued strong performance of its Hematology and Oncology growth products, including Niktimvo, Monjuvi/Minjuvi and Zynyz. Incyte is raising its full year 2026 Opzelura net sales guidance to $1,050 – $1,100 million and full year 2026 Hematology and Oncology net sales guidance to $860 – $890 million.
Incyte is also raising its full year 2026 operating expense guidance. Total GAAP R&D and SG&A operating expense guidance is $4,915 – $4,995 million and total non-GAAP R&D and SG&A operating expense guidance is $4,625 – $4,695 million. The revised guidance reflects the impact of the acquisition of Vega Therapeutics, including an IPR&D expense of approximately $1,270 million expected in the third quarter 2026 associated with the upfront payment and related transaction costs, as well as $50 million of incremental ongoing R&D investments related to the development of latarcibart. The transaction upfront payment is expected to result in an IPR&D expense reflected in the third quarter and full year 2026 GAAP and non-GAAP financial results.
Incyte’s guidance for the fiscal year 2026 is summarized below.
Current Previous
Total net sales $5,130 – $5,260 million $4,770 – $4,940 million
Jakafi net sales(1)
unchanged $3,220 – $3,270 million
Opzelura net sales(2)
$1,050 – $1,100 million $750 – $790 million
Hematology and Oncology net sales(3)
$860 – $890 million $800 – $880 million
Total GAAP R&D and SG&A operating expenses(4)
$4,915 – $4,995 million $3,495 – $3,675 million
Total Non-GAAP R&D and SG&A operating expenses(4,5)
$4,625 – $4,695 million $3,205 – $3,375 million

1Includes Jakafi XR (ruxolitinib) net sales.
2Includes net sales for moderate atopic dermatitis in Europe, which is anticipated to be approved in the second half of 2026.
3Includes Pemazyre (pemigatinib) in the U.S., Canada, Europe, Japan, Asia Pacific (APAC), Middle East and Africa (MEA), and Latin America (LatAm); Niktimvo and Monjuvi in the U.S.; Zynyz in the U.S., Europe and Japan; Iclusig (ponatinib) in Europe and MEA; and Minjuvi in Canada, Europe, Japan, APAC, MEA and LatAm.
4Includes upfront cost related to the acquisition of Vega Therapeutics, which will be recognized as an IPR&D expense impacting both the third quarter and full-year 2026 in addition to incremental R&D investment related to latarcibart.
5Adjusted to exclude the estimated cost of stock-based compensation.
Key Business Updates
Hematology

Jakafi XR (ruxolitinib)
•In May, Jakafi XR was approved by the FDA for the treatment of adults with intermediate- or high-risk myelofibrosis (MF) and adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant to hydroxyurea, as well as for adults and children aged 12 years and older with steroid-refractory acute GVHD or chronic GVHD after failure of one or two lines of systemic therapy.

Monjuvi/Minjuvi
•Data from the pivotal Phase 3 frontMIND trial evaluating tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) were presented as a featured oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May and during the Plenary Abstract session at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June. These results, which were also recently published in The Lancet, demonstrate that treatment with Tafa-Len-R-CHOP resulted in statistically significant and clinically meaningful improvements in progression-free survival (PFS), the primary endpoint in the study.
•Global regulatory submissions for Monjuvi/Minjuvi as a treatment for patients with newly diagnosed DLBCL were submitted and accepted in the second quarter of 2026. The Company anticipates a potential approval and launch in the U.S. in the first quarter of 2027.
•In June, Minjuvi was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adults with relapsed or refractory DLBCL in combination with lenalidomide. This approval represents the second regulatory approval for Minjuvi in Japan.

Niktimvo
•Topline data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026.

INCA033989 (mutCALR)
•The registrational Phase 3 study (EXCALIBUR-ET2), evaluating INCA033989 in mutCALR positive patients with ET who are resistant or intolerant to at least one prior cytoreductive therapy was initiated in mid-2026.
•Updated Phase 1 data for INCA033989 were presented at the 2026 EHA (Free EHA Whitepaper) Congress, demonstrating robust clinical activity, durable hematologic and symptom responses, molecular responses consistent with potential disease modification and a favorable tolerability profile in patients with mutCALR-positive essential thrombocythemia (ET) and MF.
•Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026.
•A Phase 1 study evaluating INCA033989 as a subcutaneous (SC) administration in mutCALR positive patients was initiated in the second quarter of 2026.

INCB160058 (JAK2V617F)
•Following a comprehensive review of available data, the Company has discontinued further development of INCB160058 to prioritize its next-generation JAK2V617F-targeted pipeline.

Latarcibart (formerly VGA039)
•In July, data from the Phase 1/2 multidose study of latarcibart in patients with von Willebrand disease (VWD) were presented at the 2026 International Society on Thrombosis and Haemostasis (ISTH) Congress, demonstrating that once-monthly SC treatment with latarcibart resulted in an 81% median reduction in annualized bleeding rate (ABR) across all bleeding categories and VWD types.
•Latarcibart is being evaluated in a global Phase 3, single-arm crossover study (VIVID-6) assessing the safety and efficacy of once-monthly SC administration of latarcibart as prophylaxis for bleeding in patients with all types of VWD. Topline data from the VIVID-6 study are anticipated in early 2029.
Oncology
INCB161734 (KRASG12D)
•The Phase 3 study (DAWN-303) evaluating INCB161734 as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) versus chemotherapy alone is ongoing.
•Data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy (mFOLFOX and GemNabP) as a first-line treatment in patients with metastatic PDAC, as well as data evaluating INCB161734 in combination with cetuximab in patients with advanced/metastatic colorectal cancer (CRC), will be highlighted as rapid oral presentations at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held October 23–27 in Madrid, Spain.

INCA33890 (TGFβR2xPD-1)†
•The Phase 3 study evaluating INCA33890 in combination with standard-of-care chemotherapy and bevacizumab as a first-line treatment in patients with microsatellite stable colorectal cancer (MSS CRC) is ongoing.
•Data from the ongoing Phase 1 trial evaluating INAC33890 in combination with standard-of-care therapies as a first-line treatment in patients with MSS CRC will be highlighted in a rapid oral presentation at the 2026 ESMO (Free ESMO Whitepaper) Congress.
INCB123667 (CDK2)
•A Phase 3 study evaluating INCB123667 in first-line maintenance ovarian cancer is expected to initiate in the second half of 2026.
•Preliminary efficacy data from the ongoing Phase 1 trial evaluating INCB123667 in combination with bevacizumab in patients with recurrent epithelial ovarian cancer (rEOC) will be highlighted in a rapid oral presentation at the 2026 ESMO (Free ESMO Whitepaper) Congress.
Inflammation and Autoimmunity (IAI)
Opzelura
•In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of Opzelura cream for the treatment of moderate AD in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. The Company expects a regulatory decision in the third quarter of 2026.
•Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Povorcitinib
•The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the European Union and the first quarter of 2027 in the U.S.
•Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.
•Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026.

Corporate Updates
•In July, the Company announced a global collaboration and license agreement with Halozyme to support the subcutaneous formulation development of INCA033989 utilizing Halozyme’s proprietary ENHANZE Technology.
•In July, the Company completed its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC. The acquisition adds latarcibart, a novel investigational monoclonal antibody in Phase 3 development for patients with VWD, to its late-stage pipeline. Under the terms of the parties’ stock purchase agreement, Incyte acquired all outstanding shares of Vega Therapeutics for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones.
•In May, the Company expanded its use of artificial intelligence (AI) across its discovery and development pipeline, entering a strategic collaboration with Edison Scientific to employ their AI scientist Kosmos, and expanding its existing collaboration with Genesis Molecular AI to build and deploy state-of-the-art AI models to accelerate discovery of novel molecules for collaboration targets selected by Incyte.
•In the second quarter of 2026, the Company entered into an exclusive license agreement with Mirum Pharmaceuticals, granting Mirum worldwide rights to zilurgisertib, an ALK2 inhibitor in development for fibrodysplasia ossificans progressiva (FOP). Under the terms of the agreement, Incyte received an upfront payment and is eligible to receive additional development and regulatory milestone payments, as well as sales-based milestones and tiered royalties in the mid-to-high single digit percent range on worldwide net sales.

2026 Second Quarter Financial Results
The financial measures presented in this press release for the three and six months ended June 30, 2026 and 2025 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.
As changes in exchange rates are an important factor in understanding period-to-period comparisons, management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand the Company’s operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Total GAAP revenues $ 1,674,039 $ 1,215,529 $ 2,946,715 $ 2,268,427
Total GAAP operating income 697,898 530,314 999,015 735,482
Total Non-GAAP operating income 773,044 382,579 1,166,717 666,220
GAAP net income 585,605 404,999 888,935 563,202
Non-GAAP net income 643,359 311,927 1,017,786 541,386
GAAP basic EPS $ 2.92 $ 2.09 $ 4.45 $ 2.91
Non-GAAP basic EPS $ 3.21 $ 1.61 $ 5.09 $ 2.79
GAAP diluted EPS $ 2.81 $ 2.04 $ 4.28 $ 2.84
Non-GAAP diluted EPS $ 3.09 $ 1.57 $ 4.90 $ 2.73

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
Six Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
2026 2025 2026 2025
Net sales
Jakafi2
$ 816,659 $ 763,788 7 % NA $ 1,574,414 $ 1,473,200 7 % NA
Opzelura 449,736 164,499 173 % 173 % 592,751 283,204 109 % 108 %
Iclusig 34,394 32,729 5 % 3 % 69,857 62,273 12 % 5 %
Pemazyre 23,418 22,192 6 % 5 % 45,961 40,632 13 % 11 %
Minjuvi/Monjuvi 53,686 31,131 72 % 72 % 102,913 60,682 70 % 67 %
Niktimvo 60,309 36,154 67 % 67 % 115,397 49,767 132 % 132 %
Zynyz 49,947 8,921 460 % 458 % 91,340 11,930 666 % 661 %
Total net sales 1,488,149 1,059,414 40 % 40 % 2,592,633 1,981,688 31 % 30 %
Royalty revenues:
Jakavi 124,190 109,714 13 % 12 % 229,746 201,859 14 % 15 %
Olumiant 38,479 33,482 15 % 16 % 74,886 64,282 16 % 14 %
Tabrecta 6,691 6,632 1 % NA 12,673 13,045 (3 %) NA
Other 5,330 1,287 314 % NA 8,577 2,553 236 % NA
Total royalty revenues 174,690 151,115 16 % 325,882 281,739 16 %
Total net sales and royalty revenues 1,662,839 1,210,529 37 % 2,918,515 2,263,427 29 %
Milestone and contract revenues 11,200 5,000 124 % 124 % 28,200 5,000 464 % 464 %
Total GAAP revenues $ 1,674,039 $ 1,215,529 38 % $ 2,946,715 $ 2,268,427 30 %

NA = not applicable
1 Percentage change in constant currency is calculated using 2025 foreign exchange rates to recalculate 2026 results.
2 Second quarter 2026 Jakafi net sales include Jakafi and Jakafi XR following the launch of Jakafi XR in the second quarter of 2026.
Net Sales and Royalty Revenues Total net sales and royalty revenue for the quarter ended June 30, 2026 increased 37% over the prior year comparative period.
•Total net sales for the quarter ended June 30, 2026 increased 40% over the prior year comparative period.
•Jakafi net sales increased 7% in the second quarter of 2026 versus the prior year comparable period to $817 million, primarily driven by a 9% increase in paid demand and growth across all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2026.
•Opzelura net sales increased 173% in the second quarter of 2026 versus the prior year comparable period to $450 million. The increase was driven in part by a one-time, non-cash benefit of $246 million associated with the reversal of previously established accrual balances through March 31, 2026, for Opzelura. Net growth was also driven by increased patient demand in both AD and vitiligo. Opzelura inventory levels were within normal range at the end of the second quarter of 2026.
•Hematology and oncology net sales increased 69% in the second quarter of 2026 versus the prior year comparable period to $222 million, driven by increased demand for Niktimvo, Monjuvi/Minjuvi and Zynyz.

Operating Expenses
INCYTE CORPORATION
RECONCILIATION OF REPORTED TO ADJUSTED RESULTS
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2026 and 2025
(unaudited, in thousands)
Three Months Ended June 30, 2026
Cost of Sales1
Research and Development2
Selling, General and Administrative3
Operating Income Net Income
GAAP (as reported) $ 104,957 $ 516,950 $ 351,735 $ 697,898 $ 585,605
Adjustments – Add / (Subtract)
Non-cash stock compensation from equity awards (932) (38,189) (28,142) 67,263 67,263
Amortization of acquired product rights (5,384) — — 5,384 5,384
Loss on change in fair value of contingent consideration — — — 2,499 2,499
Non-cash interest — — — — 81
(Gain) on equity investments — — — — (9,805)
Tax effect of Non-GAAP pre-tax adjustments — — — — (7,668)
Non-GAAP (as adjusted) $ 98,641 $ 478,761 $ 323,593 $ 773,044 $ 643,359

Three Months Ended June 30, 2025
Cost of Sales1
Research and Development2
Selling, General and Administrative3
Operating Income Net Income
GAAP (as reported) $ 78,766 $ 494,917 $ 331,022 $ 530,314 $ 404,999
Adjustments – Add / (Subtract)
Non-cash stock compensation from equity awards (838) (37,700) (26,071) 64,609 64,609
Contract dispute settlement — — — (242,251) (242,251)
Amortization of acquired product rights (5,384) — — 5,384 5,384
Loss on change in fair value of contingent consideration — — — 22,761 22,761
Escient acquisition related compensation expense — (1,582) (180) 1,762 1,762
Non-cash interest — — — — 81
Loss on equity investments — — — — 4,151
Tax effect of Non-GAAP pre-tax adjustments — — — — 50,431
Non-GAAP (as adjusted) $ 72,544 $ 455,635 $ 304,771 $ 382,579 $ 311,927

Six Months Ended June 30, 2026
Cost of Sales1
Research and Development2
Selling, General and Administrative3
Operating Income Net Income
GAAP (as reported) $ 209,480 $ 1,032,853 $ 679,822 $ 999,015 $ 888,935
Adjustments – Add / (Subtract)
Non-cash stock compensation from equity awards (1,814) (77,409) (52,166) 131,389 131,389
Amortization of acquired product rights (10,768) — — 10,768 10,768
Loss on change in fair value of contingent consideration — — — 2,331 2,331
Asset impairment and related disposal costs — — — 23,214 23,214
Non-cash interest — — — — 163
(Gain) on equity investments — — — — (16,396)
Tax effect of Non-GAAP pre-tax adjustments — — — — (22,618)
Non-GAAP (as adjusted) $ 196,898 $ 955,444 $ 627,656 $ 1,166,717 $ 1,017,786

Six Months Ended June 30, 2025
Cost of Sales1
Research and Development2
Selling, General and Administrative3
Operating Income Net Income
GAAP (as reported) $ 151,954 $ 932,196 $ 656,713 $ 735,482 $ 563,202
Adjustments – Add / (Subtract)
Non-cash stock compensation from equity awards (1,697) (74,424) (49,470) 125,591 125,591
Contract dispute settlement — — — (242,251) (242,251)
Amortization of acquired product rights (10,768) — — 10,768 10,768
Loss on change in fair value of contingent consideration — — — 34,333 34,333
Escient acquisition related compensation expense — (2,117) (180) 2,297 2,297
Non-cash interest — — — — 163
Loss on equity investments — — — — 5,494
Tax effect of Non-GAAP pre-tax adjustments — — — — 41,789
Non-GAAP (as adjusted) $ 139,489 $ 855,655 $ 607,063 $ 666,220 $ 541,386

1 Non-GAAP cost of sales excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation and Escient acquisition related compensation expense related to severance payments.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and Escient acquisition related compensation expense related to severance payments.
Cost of sales GAAP and Non-GAAP cost of sales for the quarter ended June 30, 2026 were $105.0 million and $98.6 million, respectively, representing 7% of total net sales.
Contract dispute settlement In May 2025, Incyte and Novartis entered into a settlement agreement with respect to litigation relating to the duration of royalty payments owed under the Collaboration and License Agreement between Incyte and Novartis. Under the settlement agreement, the royalty rate payable by Incyte on future net sales of Jakafi in the United Stated is reduced by 50% beginning January 1, 2025 and Incyte paid Novartis $280.0 million as the settlement of disputed royalties on net sales of Jakafi in the United States through December 31, 2024. The difference of $242.2 million between the accrued royalties and the total amount paid by us to Novartis was recorded in contract dispute settlement on the condensed consolidated statement of operations for the three and six months ended June 30, 2025.

Research and development expenses GAAP and Non-GAAP research and development expenses for the quarter ended June 30, 2026 were $517.0 million and $478.8 million, an increase of 4% and 5%, respectively, compared to the same period in 2025, primarily due to continued investment in our late stage development assets.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2026 were $351.7 million and $323.6 million, an increase of 6% for each, respectively, compared to the same period in 2025, primarily due to increased consumer marketing and pre-launch activities.
Other Financial Information
Change in fair value of acquisition-related contingent consideration The change in fair value of contingent consideration during the quarter ended June 30, 2026, compared to the same period in 2025, was primarily due to updated projections of future net sales of Iclusig, including the impacts from fluctuations in foreign currency exchange rates.
Operating income GAAP and Non-GAAP operating income for the quarter ended June 30, 2026 increased 32% and 102%, respectively, compared to the same period in 2025, driven primarily by growth in total revenue, including the impact of the $246 million of additional net sales of Opzelura relating to the aforementioned CMS agreement, and the impacts of the contract dispute settlement in the second quarter of 2025 on Non-GAAP operating income.
Cash, cash equivalents and marketable securities position Cash, cash equivalents and marketable securities as of June 30, 2026, were $4.5 billion, compared to $3.6 billion as of December 31, 2025.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13759527.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13759527.

The conference call will also be webcast live and can be accessed at investor.incyte.com.

About Incyte
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Incyte is a registered trademark of Incyte.

About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved for use in the U.S. for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to, or are intolerant of, hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Jakafi XR (ruxolitinib) Extended-Release Tablets
Jakafi XR (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, approved for use in the U.S. for the treatment of PV in adults who have had an inadequate response to, or are intolerant of, hydroxyurea; intermediate or high-risk MF, including primary MF, post-PV MF, and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi XR is safe or effective in children for the treatment of MF or PV.

Jakafi XR and the Jakafi XR logo are trademarks of Incyte.

About Opzelura (ruxolitinib) Cream
Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte’s JAK1/JAK2 inhibitor ruxolitinib, is the first and only treatment for repigmentation approved for use in the U.S. for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older. Opzelura also is approved for use in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of nonsegmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of Opzelura.

Opzelura is a registered trademark of Incyte.

About Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab)
Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved for use in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

About Pemazyre (pemigatinib)
Pemazyre (pemigatinib) is a kinase inhibitor approved for use in the U.S. for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in one or more confirmatory trials.
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Pemazyre is also the first targeted treatment approved for use in the U.S. for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, Pemazyre is approved for use for the treatment of patients with unresectable biliary tract cancer (BTC) with an FGFR2 fusion gene that worsens after cancer chemotherapy.

In Europe, Pemazyre is approved for use for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 that has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan.

Pemazyre is a trademark of Incyte.

About Iclusig (ponatinib) tablets
Iclusig (ponatinib) targets not only native BCR-ABL, an abnormal, fused gene and protein associated with several types of leukemia, most notably Chronic Myeloid Leukemia (CML) and Philadelphia-positive Acute Lymphoblastic Leukemia (Ph+ ALL), but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved tyrosine kinase inhibitors.

In Europe, Iclusig is approved for use for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, the UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

About Zynyz (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), approved for use in the U.S., Europe and Japan in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and in the U.S. as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy.

Zynyz is also approved for use as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S., Europe, Canada and Switzerland.

Incyte licenses exclusive worldwide rights to develop and commercialize Zynyz from MacroGenics, Inc.

Zynyz is a registered trademark of Incyte.

About Niktimvo (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In September 2021, Syndax Pharmaceuticals, Inc. and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

(Press release, Incyte, JUL 28, 2026, View Source [SID1234669459])

Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML

On July 28, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 (EOP1) meeting for CLN-049, a FLT3xCD3 T cell engager being evaluated in patients with acute myeloid leukemia (AML).

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The EOP1 meeting focused on the planned Phase 2 development strategy for CLN-049. Based on discussions with the FDA, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026. The study design agreed with the FDA incorporates a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose.

"Patients with AML continue to face poor outcomes and have limited treatment options, underscoring the need for new therapeutic approaches," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "The FDA’s feedback reinforces our confidence in the development strategy for CLN-049 and provides a clear path forward for potential regulatory approval. We look forward to continuing to advance the CLN-049 program and exploring its potential across AML patient populations."

As presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, CLN-049 demonstrated promising clinical activity and a favorable safety profile in patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of this study in Q4 2026.

Following the positive feedback from the FDA, the Company plans to initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 2026. The Company will also initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML (NCT07722767).

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 bispecific T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.2 Each year in the U.S., approximately 23,000 people are diagnosed with AML, and about half as many lives are lost to the disease.3 Globally, AML affects an estimated 145,000 people annually, with approximately 130,000 deaths.4

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.5 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.6,7 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.7 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, JUL 28, 2026, View Source [SID1234669475])