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Novartis delivered strong growth in priority brands and launches in Q1; FY 2026 guidance reaffirmed

On April 28, 2026 Vas Narasimhan, CEO of Novartis reported on Q1 2026 results, said:

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"Novartis delivered a strong start to 2026 across our priority brands and launches, while US generic erosion weighed on results in Q1 as expected. We continued to advance our pipeline, with compelling Phase III results for remibrutinib in chronic inducible urticaria and Phase II data in food allergy, reinforcing the medicine’s pipeline-in-a-pill potential. We also completed the acquisition of Avidity and announced early-stage deals to support our breast cancer and allergic disease franchises. With the momentum we are seeing across the business, we remain on track to deliver our full year guidance and look forward to multiple readouts in the second half that could raise our mid- to long-term growth outlook."

Key figures

Q1 2026 Q1 2025 % change

USD m3 USD m3 USD cc
Net sales 13 113 13 233 -1 -5
Operating income 4 235 4 663 -9 -11
Net income 3 156 3 609 -13 -13
EPS (USD) 1.65 1.83 -10 -11
Free cash flow 3 330 3 391 -2

Core operating income 4 897 5 575 -12 -14
Core net income 3 794 4 482 -15 -17
Core EPS (USD) 1.99 2.28 -13 -15

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 32 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 6. 3. USD millions unless indicated otherwise.

Strategy
Our focus
Novartis is a "pure-play" innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.
Financials
First quarter
Net sales were USD 13.1 billion (-1%, -5% cc), with volume contributing 13 percentage points to growth, more than offset by 14 percentage points of generic competition. Pricing had a negative impact of 4 percentage points, including net 1 percentage point from revenue deduction adjustments in the US, and currency had a positive impact of 4 percentage points.

Operating income was USD 4.2 billion (-9%, -11% cc), declining due to lower net sales and higher R&D investments, partly offset by higher divestment gains.

Net income was USD 3.2 billion (-13%, -13% cc), mainly due to lower operating income. EPS was USD 1.65 (-10%, -11% cc), due to lower net income, partly offset by the benefit of the lower weighted average number of shares outstanding.

Core operating income was USD 4.9 billion (-12%, -14% cc), declining due to lower net sales and higher R&D investments. Core operating income margin was 37.3% of net sales, decreasing 4.8 percentage points (4.1 percentage points in cc).

Core net income was USD 3.8 billion (-15%, -17% cc), mainly due to lower core operating income. Core EPS was USD 1.99 (-13%, -15% cc), due to lower core net income, partly offset by the benefit of the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 3.3 billion, broadly in line with the prior-year quarter.

Q1 priority brands
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q1 growth) including:

Kisqali (USD 1 516 million, +55% cc) sales grew strongly across all regions, with continued momentum in the early breast cancer indication as well as leadership in metastatic breast cancer.
Pluvicto (USD 642 million, +70% cc) sales showed continued strong demand in the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) setting in the US, as well as access expansion ex-US.
Kesimpta (USD 1 164 million, +26% cc) sales grew across all regions, driven by increased demand and strong access.
Leqvio (USD 452 million, +69% cc) accelerated growth ex-US, driven by strong uptake in China following NRDL-listing.
Scemblix (USD 433 million, +79% cc) sales grew across all regions, with continued strong momentum from the early-line indication in the US, Japan and Germany.
Fabhalta (USD 169 million, +103% cc) sales more than doubled in Q1, reflecting continued expansion in PNH and renal indications.
Rhapsido (USD 37 million) continued to show strong early uptake in the US, supported by a free drug program to facilitate patient access and increasing coverage.
Cosentyx (USD 1 566 million, -2% cc) sales were broadly stable. US sales declined, as demand growth was offset by positive revenue deduction adjustments in the prior-year quarter. Ex-US, sales continued to grow. Underlying sales growth globally was +2% cc.
Zolgensma Group (USD 302 million, -12% cc) sales declined, reflecting a lower incidence of SMA, despite continued strong share in the incident population, as well as treatment phasing.
Net sales of the top 20 brands in the first quarter

Q1 2026 % change

USD m USD cc
Cosentyx
– excluding revenue deduction adjustments* 1 566 2
5 -2
2
Kisqali 1 516 59 55
Entresto 1 305 -42 -46
Kesimpta 1 164 29 26
Pluvicto 642 73 70
Jakavi 557 13 5
Tafinlar+Mekinist 493 -11 -14
Ilaris 475 13 10
Leqvio 452 76 69
Scemblix 433 82 79
Xolair 388 -15 -20
ZolgensmaGroup 302 -8 -12
SandostatinGroup 287 -9 -12
Lutathera 211 9 7
ExforgeGroup 203 13 7
Promacta/Revolade 184 -66 -68
Fabhalta 169 109 103
Tasigna 155 -59 -61
DiovanGroup 150 0 -4
Myfortic 111 12 9
Top 20 brands total 10 763 1 -3
*Q1 sales growth impacted by US revenue deduction adjustments in the current and prior year.

R&D update – key developments from the first quarter
New approvals
Cosentyx
(secukinumab) FDA approved Cosentyx for the treatment of moderate to severe hidradenitis suppurativa (HS) in pediatric patients aged 12 years and older, making it the only IL‑17A inhibitor approved for this population.
Regulatory updates
Rhapsido
(remibrutinib) EMA’s CHMP adopted a positive opinion recommending marketing authorization for remibrutinib as an oral treatment for chronic spontaneous urticaria (CSU) in adults with an inadequate response to H1‑antihistamine therapy.
Ianalumab
(VAY736) FDA granted Breakthrough Therapy designation and priority review to ianalumab for the treatment of Sjögren’s disease, following the first global Phase III trials to demonstrate a statistically significant reduction in disease activity.

Regulatory submissions were completed for ianalumab in the US, Europe, China and Japan.
Cosentyx
(secukinumab) Regulatory submissions were completed for Cosentyx in polymyalgia rheumatica (PMR) in the US, Europe and Japan.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Novartis withdrew its EMA type II variation application for Pluvicto to treat adult patients with PSMA+ mCRPC pre-chemotherapy, following CHMP feedback that they would not support the application. The withdrawal is not related to the quality, efficacy or safety of Pluvicto and does not impact ongoing clinical trials, approved indications or pending regulatory submissions inside or outside the EU.

Importantly, the PSMAfore study, which supported the application, was the basis for the successful approval of Pluvicto in the pre-chemotherapy setting in the US, Japan and China. Pluvicto’s value in this population is also reflected in evidence-based recommendations from leading professional guidelines, including ESMO (Free ESMO Whitepaper), EAU, ASCO (Free ASCO Whitepaper) and NCCN Guidelines.
Results from ongoing trials and other highlights
Remibrutinib Positive topline results from the pivotal Phase III RemIND trial showed oral remibrutinib met its primary endpoint in chronic inducible urticaria (CIndU), achieving statistically significant and clinically meaningful complete response rates versus placebo at Week 12 across the three most prevalent CIndU types: symptomatic dermographism, cold urticaria and cholinergic urticaria. Remibrutinib was well tolerated and demonstrated a favorable safety profile, with no liver safety concerns reported. Based on these results, an sNDA for the treatment of symptomatic dermographism has been submitted to the FDA. Full data will be presented at an upcoming medical congress and submitted to health authorities globally.

In a Phase II study in adults with IgE‑mediated peanut allergy, remibrutinib demonstrated superior efficacy versus placebo, with dose‑dependent effects and a rapid onset of action, and was well tolerated. Data were presented at the AAAAI Annual Meeting. A Phase III program in food allergy is on track to start in H2 2026.
Fabhalta
(iptacopan) In the Phase III APPLAUSE‑IgAN study, final two‑year results published in The New England Journal of Medicine showed that Fabhalta slowed kidney function decline by 49.3% versus placebo and reduced the risk of composite kidney failure events in adult patients with IgA nephropathy (IgAN). The safety profile was consistent with previous findings. Fabhalta was granted priority review by FDA for traditional approval.
Vanrafia
(atrasentan) Final results from the Phase III ALIGN study showed a slowing in kidney function decline in IgAN patients treated with Vanrafia, with a positive difference in eGFR change from baseline vs. placebo at Week 136 (4 weeks after the end of study treatment, p = 0.057) and at Week 132 (at the end of treatment, nominal p = 0.039). Safety was consistent with previous findings. Novartis plans to submit these data for traditional approval in H1 2026.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Real‑world analyses from the Novartis PRECISION platform showed that Pluvicto achieved a median progression‑free survival (PFS) of 13.5 months in men with PSMA+ mCRPC who were taxane‑naïve and had received at least one androgen receptor pathway inhibitor (ARPI). Longer median PFS was observed when Pluvicto was initiated after one prior ARPI compared with use after multiple ARPIs. Data were presented at the ASCO (Free ASCO Whitepaper)-GU Symposium.
Cosentyx
(secukinumab) In a matched adjusted indirect comparison analysis of efficacy and safety from Phase III trials in HS, including SUNSHINE and SUNRISE, Cosentyx showed greater flare prevention and a lower risk of Candida infections compared with bimekizumab through Week 48, while maintaining similar HiSCR50 responses. Data were presented at AAD.
Del-zota One‑year data from the Phase I/II EXPLORE44 and EXPLORE44‑OLE studies evaluating del-zota in individuals with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44) showed sustained reductions in serum creatine kinase levels, significant increases in dystrophin, and improvements in multiple functional measures. Safety profile observed to date is consistent with earlier findings. Data were presented at MDA.
Del-desiran Final results from the Phase I/II MARINA study of del-desiran in adults with myotonic dystrophy type 1 (DM1), published in The New England Journal of Medicine, showed effective delivery to muscle and a reduction in DMPK mRNA, and improvements across multiple functional measures. Safety profile observed to date is consistent with earlier findings. Del‑desiran is currently being evaluated in the Phase III HARBOR study in DM1, with readout anticipated in H2 2026.
Selected transactions Novartis successfully completed the acquisition of Avidity Biosciences, strengthening its late-stage neuroscience pipeline and advancing its xRNA strategy.

Novartis entered into an agreement with Synnovation Therapeutics to acquire SNV4818, a pan‑mutant selective PI3Kα inhibitor currently in Phase I/II for patients with HR+/HER2‑ breast cancer and other advanced solid tumors. The program aligns with Novartis’ strategy in breast cancer, and fits naturally alongside CDK inhibitors as well as endocrine (hormonal) therapies as part of a potential combination regimen. The transaction is expected to close in H1 2026, subject to customary closing conditions.

Novartis entered into an agreement to acquire Excellergy, including Exl-111, a half-life extended, high-affinity anti-IgE antibody in Phase I, with a differentiated mechanism designed to dissociate receptor-bound IgE and drive faster and deeper FcεRIα downregulation. This acquisition builds on deep Novartis expertise in IgE biology and allergic disease, with the potential to offer earlier symptom relief, stronger disease control and more convenient dosing. The transaction is expected to close in H2 2026, subject to customary closing conditions.
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

In Q1 2026, Novartis repurchased a total of 10.4 million shares for USD 1.6 billion on the SIX Swiss Exchange second trading line under the up-to USD 10 billion share buyback announced in July 2025 (with up to USD 6.1 billion still to be executed). In addition, 2.0 million shares (equity value of USD 0.3 billion) were repurchased from employees. In the same period, 12.3 million shares (equity value of USD 0.3 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the 2026 dilution related to equity-based compensation plans of employees over the remainder of the year, in addition to the share repurchases under the up-to USD 10 billion share buyback. Consequently, the total number of shares outstanding decreased by 0.1 million versus December 31, 2025. These treasury share transactions resulted in an equity decrease of USD 1.6 billion and a cash outflow of USD 1.9 billion.

Net debt increased to USD 38.1 billion at March 31, 2026, compared to USD 21.9 billion at December 31, 2025. The increase was mainly due to the free cash flow of USD 3.3 billion being more than offset by the net cash outflow for M&A and intangible asset transactions of USD 12.5 billion, the USD 6.2 billion annual net dividend payment in March (which is the gross dividend of USD 9.1 billion reduced by the USD 2.9 billion Swiss withholding tax paid in April 2026, according to its due date), and cash outflows for treasury share transactions of USD 1.9 billion.

As of Q1 2026, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2026 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow low single-digit
Core operating income Expected to decline low single-digit

Foreign exchange impact
If late-April exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 2 percentage points on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1

Q1 2026 Q1 2025 % change
USD m2 USD m2 USD cc
Net sales 13 113 13 233 -1 -5
Operating income 4 235 4 663 -9 -11
As a % of sales 32.3 35.2
Net income 3 156 3 609 -13 -13
EPS (USD) 1.65 1.83 -10 -11
Net cash flows from operating activities 3 676 3 645 1
Non-IFRS measures
Free cash flow 3 330 3 391 -2
Core operating income 4 897 5 575 -12 -14
As a % of sales 37.3 42.1
Core net income 3 794 4 482 -15 -17
Core EPS (USD) 1.99 2.28 -13 -15

(Press release, Novartis, APR 28, 2026, View Source [SID1234664811])

Entry Into Material Definitive Agreement

On April 27, 2026, Oncotelic Inc. (the "Company"), a wholly owned subsidiary of Oncotelic Therapeutics, Inc., entered into an Agreement and Plan of Merger (the "Merger Agreement") with Lunai Bioworks, Inc., a Delaware corporation ("Lunai"), Lunai Bioworks IP, Inc., a Delaware corporation and a wholly owned subsidiary of Lunai ("Merger Sub"), Neurobridge IP Holdings Incorporated, a Delaware corporation ("Holdings"), and the holders of all of the issued and outstanding capital stock of Holdings, namely the Company and Pelerin Therapeutics Inc., a corporation existing under the laws of the Province of British Columbia, Canada ("Pelerin" and, together with the Company, the "Holders"). Pursuant to the Merger Agreement, Holdings merged with and into Merger Sub in a triangular merger (the "Merger"), with Merger Sub continuing as the surviving corporation and as a wholly owned subsidiary of Lunai. The Merger was completed on May 1, 2026, and the information set forth under Item 2.01 below regarding the completion of the Merger is incorporated into this Item 1.01 by reference.

Immediately prior to the effective time of the Merger, all of the issued and outstanding capital stock of Holdings was owned 62.5% by the Company and 37.5% by Pelerin. The sole assets of Holdings at the effective time of the Merger consisted of a multi-jurisdictional patent portfolio (collectively, and as further defined in the Merger Agreement, the "Patents"), which the Holders had contributed to Holdings prior to the effective time. A complete listing of the Patents is set forth on Schedule 3.6 to the Merger Agreement. The assets of Holdings at the time of the merger consisted solely of those patents and patent applications; Holdings had no continuity of revenue-producing activity or operating infrastructure, including no employees, customers, sales force, distribution system, facilities, production techniques, trade names or revenue-producing operations, and had no material liabilities.

In consideration for the Merger, on May 1, 2026 Lunai issued to the Holders an aggregate of eight (8) shares of a newly designated series of preferred stock of the Company, designated as "Series B Convertible Preferred Stock" (the "Series B Preferred Stock"), having an aggregate stated value (the "Stated Value") of $20,000,000. The Series B Preferred Stock was allocated five (5) shares to the Company (representing 62.5% of the Series B Preferred Stock and an aggregate Stated Value of $12,500,000) and three (3) shares to Pelerin (representing 37.5% of the Series B Preferred Stock and an aggregate Stated Value of $7,500,000).

The foregoing description of the Merger Agreement is a summary only and is qualified in its entirety by reference to the full text of the Merger Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report on Form 8-K and is incorporated herein by reference.

IP Assignment Agreement

In connection with the Merger Agreement, on April 27, 2026, the Company entered into an IP Assignment Agreement with Holdings, pursuant to which it agreed to contribute and assign certain assets relating to the intellectual property of the Company (collectively, the "Intellectual Property Assets") to Holdings.

The Intellectual Property Assets include:(a) (i) the patents and patent applications and all issuances, divisions, continuations, continuations-in-part, reissues, extensions, reexaminations, and any foreign counterparts of any of the foregoing including the right to claim priority and renewals thereof; (ii) the trademarks and all issuances, extensions, and renewals thereof, with the goodwill of the business connected with using, and symbolized by, the trademarks; (iii) the copyright and exclusive copyright licenses and all issuances, extensions, and renewals thereof; and (iv) the domain names; (b) all non-registered intellectual property relating to the Intellectual Property Assets, with the goodwill of the business connected with using, and symbolized by, all such non-registered intellectual property to the extent applicable; (c) any and all royalties, fees, income, payments, and other proceeds now or hereafter due or payable regarding all of the foregoing; and (d) any and all claims and causes of action, regarding any of the foregoing, whether accruing before, on, or after the date hereof, including all rights to and claims for damages, restitution, and injunctive and other legal and equitable relief for past, present, and future infringement, dilution, misappropriation, violation, misuse, breach, or default, with the right but no obligation to sue for such legal and equitable relief and to collect, or otherwise recover, any such damages.

The foregoing description of the IP Assignment is a summary only and is qualified in its entirety by reference to the full text of the IP Assignment, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

IP Grant-back Agreement

Further, on April 27, 2026, the Company and Holdings entered into an Intellectual Property Assignment and Grant-back Agreement (the "IP Grant-back Agreement"). The IP Grant-back Agreement grants back to the Company a perpetual, irrevocable, royalty-free, exclusive, non-terminable, and non-cancellable license to make, have made, use, offer to sell, sell, and otherwise exploit the Intellectual Property Assets in all fields of use except the Biodefense Field and the Alzheimer’s Disease Field as defined in the IP Grant-back Agreement, giving Holdings exclusive use of the Intellectual Property Assets in those fields.

For purposes of the IP Grant-back Agreement, the Biodefense Field means the use of the Intellectual Property Assets for all medical countermeasure (MCM) applications, including but not limited to chemical agents (nerve, blood), biological toxins (ricin, SEB), and viral encephalitides, as well as the prevention, mitigation, diagnosis, or treatment of conditions arising from or associated with chemical agents, biological agents, toxins, radiological exposure, nuclear exposure, or other external threat agents, including acute central nervous system injury or systemic injury resulting from such threats, and including applications related to pandemic preparedness or mass-casualty events and the Alzheimer’s Disease Field means the use of the Intellectual Property solely for the prevention, diagnosis, or treatment of Alzheimer’s disease. For the avoidance of doubt, the grant-back conveys back to the Company all rights of use with respect to OT-101, within or without the Field of Use, including all formulations, derivatives, modifications, enhancements, dosing regimens, methods of use, and any combinations of OT-101 with other active ingredients, products, technologies, or therapies, provided such combinations do not utilize other Assigned Intellectual Property outside the Field of Use.

The foregoing description of the IP Grant-back Agreement is a summary only and is qualified in its entirety by reference to the full text of the IP Grant-back Agreement, a copy of which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Asset Transfer Agreement

Further, on April 30, 2026, the Company and Autotelic Inc. ("Autotelic") entered into an asset transfer agreement (the "Asset Transfer Agreement") pursuant to which Autotelic agreed to transfer all the rights, title and interest to certain assets ("Assets"), described below and owned by Autotelic to the Company. This Asset Transfer Agreement was entered into by both parties to effectuate the Merger Agreement. Dr. Trieu, Chairman and CEO of Oncotelic Thereaputics, Inc., is a partial owner and control person in Autotelic Inc. Autotelic Inc. currently owns less than 10% of the Company.

The Assets transferred pursuant to the Asset Transfer Agreement include Peptide Y (including all variants, analogs, derivatives); Parathyroid Hormone (PTH), including PTH 1-34, PTH 1-84, and derivatives; Insulin (including intranasal and other formulations); Apomorphine (including intranasal and other formulations); Carbetocin (including intranasal and other formulations); any associated combination therapies, including multi-agent CNS, Alzheimer’s disease, metabolic, endocrine, or biodefense applications; and all delivery platforms, including nasal, injectable, and device-based systems and includes all patents, patent applications, know-how, trade secrets, data, formulations, manufacturing processes, regulatory filings, and all related rights associated with the Assets. In consideration for the transfer of the Assets, the Company shall issue equity of ten percent (10%) of the fully diluted outstanding shares of Oncotelic Therapeutics, Inc. issuable on an uplisting of its capital stock to NYSE/NASDAQ. No cash was paid for the Asset Transfer Agreement.

(Filing, Oncotelic, APR 27, 2026, View Source [SID1234665122])

AstraZeneca’s Infineon and Inspiron, combined with Inspiron, have been approved for marketing in China as first-line treatment for HCC.

On April 27, 2026 AstraZeneca (NYSE: AZN) reported that the China National Medical Products Administration has officially approved Imfinzi (Imfinzi,Durvalumab in combination with ImjudoTrimelimab is used as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In addition,Durvalumab has also been approved as monotherapy for first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC). In early April, this combination regimen was approved in China, along with platinum-based chemotherapy, for first-line treatment of metastatic non-small cell lung cancer (NSCLC) that is negative for epidermal growth factor receptor (EGFR) sensitive mutations and anaplastic lymphoma kinase (ALK).

This approval is based on the results of the global Phase III clinical trial HIMALAYA and the Chinese cohort. Global cohort data shows that, compared to…Compared with sorafenib monotherapy , the STRIDE regimen significantly reduced the risk of death by 22% in patients (hazard ratio [HR] 0.78; 95% confidence interval [CI], 0.66–0.92; p = 0.0035). (Single dose)Trimerumab combined with fixed intervalThe median overall survival (OS) in the durvalumab (STRIDE) combination therapy group was 16.4 months, whileThe sorafenib group had a duration of 13.8 months.durvalumab monotherapy compared toSorafenib demonstrated a non-inferiority benefit in overall survival (OS) (HR 0.86; 95% CI, 0.73–1.02), with a pre-specified non-inferiority margin of 1.08 (based on the upper limit of 95.67% CI).The median overall survival (OS) in the durvalumab monotherapy group was 16.6 months.

The HIMALAYA study’s Chinese cohort analysis showed a clear long-term benefit trend for the STRIDE regimen, consistent with the global benefit trend. The median overall survival (OS) in the STRIDE combination therapy group was 25.3 months, compared to…In the sorafenib group (median OS of 14.1 months), the survival time was extended by more than 11 months, with a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.42-0.84), and the 3-year OS rate reached 40.6%, approximately [missing data].Twice that of the sorafenib control group. In terms of safety, the STRIDE regimen is comparable to…Durvalumab monotherapy demonstrated good safety and tolerability in both groups. Data showed that the STRIDE regimen group and…The incidence of grade 3 or higher treatment-related adverse events (TRAE) in the durvalumab monotherapy group was 24.1% and 12.4%, respectively, both lower than that in the control group.40.2% in the Sorafenib group.

(Press release, AstraZeneca, APR 27, 2026, View Source;utm_source=official [SID1234665019])

Jecho Laboratories, Inc. Announces FDA Acceptance of Investigational New Drug (IND) Application for JLM019 for Advanced Malignancies

On April 27, 2026 Jecho Laboratories, Inc. ("Jecho"), a clinical-stage biotechnology company focused on developing innovative therapeutics, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for JLM019.

JLM019 is a CD80/PD-1 dual-target Fc fusion protein with a unique bidirectional synergistic mechanism. With its precise targeting design, the drug is expected to overcome the limitations of existing immunotherapies, improve immunotherapy response rates, and delay the development of tumor cell resistance. As a result, it has the potential to significantly enhance immunotherapy and provide new treatment options and hope for survival for patients with advanced solid tumors and lymphomas.

JLM019 is currently in a Phase 1 study for advanced malignant tumors in Peking Union Medical College Hospital, as it was approved to commence clinical trials by China’s National Medical Products Administration (NMPA) in September 2025. The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of JLM019 injection in patients with advanced malignancies.

This achievement marks the third U.S. FDA IND clearance Jecho has obtained and the 11th overall IND clearance.

(Press release, Jecho Laboratories, APR 27, 2026, View Source [SID1234664969])

BriaCell Announces Six Clinical Data Presentations at ASCO 2026

On April 27, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported three clinical data poster presentations and three publication-only abstracts at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2, 2026 at McCormick Place, Chicago, Illinois. The details of the poster presentation sessions and publish-only abstracts are listed below.

Abstract Title: Survival with Bria-IMT + CPI in advanced metastatic breast cancer at 12 and 24 months.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 222
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT

Abstract Title: Quality of life and treatment tolerability of Bria-IMT + CPI in metastatic breast cancer.
Session Type/Title: Poster Session – Breast Cancer—Metastatic
Poster Board: 221
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT

Abstract Title: Monitoring blood-based biomarkers as early predictors of progression-free survival in a randomized Bria-ABC phase 3 trial for advanced metastatic breast cancer: An ongoing analysis.
Session Type/Title: Poster Session – Developmental Therapeutics—Immunotherapy
Poster Board: 442
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT

Publication-Only Abstract Title: Cell-based second-generation immunotherapy BC1 in metastatic breast cancer.

Publication-Only Abstract Title: Liquid biopsy to stratify metastatic breast cancer progression risk using multi-analyte cell subtyping prior to systemic therapy.

Publication-Only Abstract Title: Monitoring PD-L1 expression in circulating cancer associated cells for prediction of clinical outcomes in metastatic breast cancer patients treated with immune checkpoint inhibitors.

Presentation details will become available upon publication of the abstracts by ASCO (Free ASCO Whitepaper) on May 21, 2026 at 5:00 PM ET.

Following the presentation, copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, APR 27, 2026, View Source [SID1234664854])