Pfizer Reports Strong First-Quarter Results And Reaffirms 2026 Guidance

On May 5, 2026 Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2026 and reaffirmed its full-year 2026 financial guidance(2).

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:
"We’re off to a strong start in 2026, and it reinforces our confidence that we will successfully navigate this defining period for Pfizer. Our R&D pipeline is advancing on multiple fronts – with positive Phase 3 readouts and encouraging mid-stage results building meaningful momentum – and I’m particularly encouraged by what we’re seeing in oncology and obesity, two areas where I believe Pfizer is positioned to lead."
David Denton, CFO and EVP of Pfizer:
"Our first-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the 22% year-over-year operational revenue growth from our launched and acquired products(1). Today, we are reaffirming our full-year 2026 financial guidance."

OVERALL RESULTS
■First-Quarter 2026 Revenues of $14.5 Billion, Representing 2% Year-over-Year Operational Growth
–Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 7% Operationally
–Revenues of Launched and Acquired Products(1) Grew 22% Operationally
■First-Quarter 2026 Reported(3) Diluted EPS of $0.47, and Adjusted(4) Diluted EPS of $0.75
■Reaffirms All Components of Full-Year 2026 Financial Guidance(2), including Revenues in a Range of $59.5 to $62.5 Billion and Adjusted(4) Diluted EPS in a Range of $2.80 to $3.00

Beginning in the first quarter of 2026, we made organizational changes in our commercial organization within the Global Biopharmaceuticals Business (Biopharma) to better support and optimize performance across our product portfolios. These changes include the transition of certain off-patent branded and generic sterile injectables and biosimilars primarily from the Specialty Care and Oncology product portfolios to a new Hospital and Biosimilars product portfolio and the creation of a new Global Hospital and Biosimilars Division within Biopharma. See the Item 1. Business––Commercial Operations section of Pfizer’s 2025 Annual Report on Form 10-K (available at www.pfizer.com and www.sec.gov).
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the first quarter of 2026 and 2025(6) are summarized below.
($ in millions, except per share amounts)
First-Quarter
2026 2025
% Change
Revenues $ 14,451 $ 13,715 5%
Reported(3) Net Income
2,687 2,967 (9%)
Reported(3) Diluted EPS
0.47 0.52 (10%)
Adjusted(4) Income
4,290 5,237 (18%)
Adjusted(4) Diluted EPS
0.75 0.92 (18%)

REVENUES
($ in millions) First-Quarter
2026 2025 % Change
Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 14,161 $ 13,441 5% 2%
Pfizer CentreOne
289 273 6% 1%
TOTAL REVENUES $ 14,451 $ 13,715 5% 2%

2026 FINANCIAL GUIDANCE(2)
■Reaffirms all components of full-year 2026 Financial Guidance(2), including Revenues in a range of $59.5 to $62.5 billion and Adjusted(4) Diluted EPS in a Range of $2.80 to $3.00.
Revenues
$59.5 to $62.5 billion
Adjusted(4) SI&A Expenses
$12.5 to $13.5 billion
Adjusted(4) R&D Expenses
$10.5 to $11.5 billion
Effective Tax Rate on Adjusted(4) Income
Approximately 15.0%
Adjusted(4) Diluted EPS
$2.80 to $3.00

CAPITAL ALLOCATION

During the first three months of 2026, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$2.5 billion invested in internal research and development projects, and
•Approximately $110 million invested in business development transactions.
▪Returning capital directly to shareholders through $2.4 billion of cash dividends, or $0.43 per share of common stock.

Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy.
No share repurchases have been completed to date in 2026. As of May 5, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026.
Diluted weighted-average shares outstanding of 5,731 million and 5,710 million were used to calculate Reported(3) and Adjusted(4) diluted EPS for first-quarter 2026 and 2025, respectively.

QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2026 vs. First-Quarter 2025)
First-quarter 2026 revenues totaled $14.5 billion, an increase of $736 million, or 5%, compared to the prior-year quarter, reflecting an operational increase of $304 million, or 2%, and a favorable impact of foreign exchange of $431 million. The operational increase was primarily driven by an increase in revenues for Padcev, Eliquis, Oncology biosimilars, Nurtec and several other products across categories, partially offset primarily by a year-over-year decline in COVID-19 product revenues. Excluding contributions from Comirnaty and Paxlovid, revenues for the first quarter grew 7% operationally. Additionally, first-quarter revenues of our Launched and Acquired Products(1) grew 22% operationally.
First-quarter 2026 operational revenue growth was driven primarily by:
▪Padcev globally, up 39% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC) as well as contribution from launch momentum in the cisplatin-ineligible indication for muscle-invasive bladder cancer (MIBC);
▪Eliquis globally, up 8% operationally, driven primarily by higher demand globally, partially offset by declines due to generic entry and price erosion in certain international markets;
▪Oncology biosimilars globally, up 52% operationally, driven primarily by favorable net price in the U.S. and supply recovery, with both drivers partially reflecting one-time impacts;
▪Nurtec ODT/Vydura globally, up 41% operationally, driven primarily by strong demand and one-time net price favorability in the U.S., as well as recent launches in certain international markets;
▪Lorbrena globally, up 32% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 4% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across markets as well as improved access in certain international markets. In the U.S., revenues declined primarily due to net price erosion as a result of new payer contracts, partially offset by continued market expansion;
▪Xeljanz globally, up 34% operationally, driven primarily by favorable net price in the U.S., partially offset by lower demand internationally; and
▪Abrysvo globally, up 31% operationally. U.S. growth was primarily driven by a lower returns provision compared to the prior-year quarter, partially offset by lower vaccine rates. International growth was primarily driven by launch uptake in certain international markets, partially offset by unfavorable timing of deliveries for the maternal indication in certain international markets;
partially offset primarily by lower revenues for:

▪Comirnaty globally, down 59% operationally, driven primarily by a decline in international markets from both lower contractual deliveries and a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination; and
▪Paxlovid globally, down 63% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower government purchases in certain international markets.
GAAP Reported(3) Statement of Operations Highlights
SELECTED REPORTED(3) COSTS AND EXPENSES
($ in millions) First-Quarter
2026 2025 % Change
Total Oper.
Cost of Sales(3)
$ 3,548 $ 2,845 25% 15%
Percent of Revenues
24.6 % 20.7 % N/A N/A
SI&A Expenses(3)
2,961 3,031 (2%) (4%)
R&D Expenses(3)
2,490 2,203 13% 12%
Acquired IPR&D Expenses(3)
137 9 * *
Other (Income)/Deductions—net(3)
861 953 (10%) (13%)
Effective Tax Rate on Reported(3) Income
14.6 % (6.8 %)
* Indicates calculation not meaningful or results are greater than 100%.

First-quarter 2026 Cost of Sales(3) as a percentage of revenues increased by 3.8 percentage points compared to the prior-year quarter, primarily driven by the non-recurrence of a favorable revision of our estimate of accrued royalties in the first quarter of 2025 as well as an unfavorable impact of foreign exchange.
First-quarter 2026 SI&A Expenses(3) decreased 4% operationally compared to the prior-year quarter, primarily reflecting lower marketing and promotional spending on various products from more targeted investments and ongoing productivity improvements, as well as lower spending in corporate enabling functions; partially offset by an unfavorable impact of foreign exchange.
First-quarter 2026 R&D Expenses(3) increased 12% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates.
Pfizer’s effective tax rate on Reported(3) income for the first quarter of 2026 increased compared to the prior-year quarter primarily due to an unfavorable change in the jurisdictional mix of earnings as well as the non-recurrence of favorable global income tax resolutions.

▪Comirnaty globally, down 59% operationally, driven primarily by a decline in international markets from both lower contractual deliveries and a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination; and
▪Paxlovid globally, down 63% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower government purchases in certain international markets.
GAAP Reported(3) Statement of Operations Highlights
SELECTED REPORTED(3) COSTS AND EXPENSES
($ in millions) First-Quarter
2026 2025 % Change
Total Oper.
Cost of Sales(3)
$ 3,548 $ 2,845 25% 15%
Percent of Revenues
24.6 % 20.7 % N/A N/A
SI&A Expenses(3)
2,961 3,031 (2%) (4%)
R&D Expenses(3)
2,490 2,203 13% 12%
Acquired IPR&D Expenses(3)
137 9 * *
Other (Income)/Deductions—net(3)
861 953 (10%) (13%)
Effective Tax Rate on Reported(3) Income
14.6 % (6.8 %)
* Indicates calculation not meaningful or results are greater than 100%.

First-quarter 2026 Cost of Sales(3) as a percentage of revenues increased by 3.8 percentage points compared to the prior-year quarter, primarily driven by the non-recurrence of a favorable revision of our estimate of accrued royalties in the first quarter of 2025 as well as an unfavorable impact of foreign exchange.
First-quarter 2026 SI&A Expenses(3) decreased 4% operationally compared to the prior-year quarter, primarily reflecting lower marketing and promotional spending on various products from more targeted investments and ongoing productivity improvements, as well as lower spending in corporate enabling functions; partially offset by an unfavorable impact of foreign exchange.
First-quarter 2026 R&D Expenses(3) increased 12% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates.
Pfizer’s effective tax rate on Reported(3) income for the first quarter of 2026 increased compared to the prior-year quarter primarily due to an unfavorable change in the jurisdictional mix of earnings as well as the non-recurrence of favorable global income tax resolutions.

Product/Project
Milestone
Recent Development Link
Elrexfio (elranatamab)
Phase 3 Results
April 2026. Announced positive topline results from the Phase 3 MagnetisMM-5 study evaluating Elrexfio as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, as assessed by BICR, versus standard-of-care daratumumab plus pomalidomide and dexamethasone. The safety and tolerability of Elrexfio was consistent with its known safety profile.
Full Release
Hympavzi (marstacimab)
Regulatory
March 2026. Announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Hympavzi to expand the approved indication to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors, or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. The European Commission will review the CHMP recommendation and is expected to make a final decision in the coming months.
Full Release
Regulatory
February 2026. Announced the FDA accepted and granted priority review for the supplemental Biologics License Application (sBLA) for Hympavzi to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the second quarter of 2026.
Full Release
Padcev (enfortumab vedotin)
Regulatory
April 2026. Pfizer and Astellas Pharma Inc. announced the FDA accepted for priority review a sBLA for perioperative (before and after surgery) Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as treatment for patients with muscle-invasive bladder cancer (MIBC). This regimen was FDA-approved in November 2025 for use as perioperative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility. The FDA has set a PDUFA target action date of August 17, 2026.
Full Release
Phase 3 Results
February 2026. Pfizer and Astellas announced positive results from the investigational Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for Padcev in combination with pembrolizumab in patients with MIBC eligible for cisplatin-based chemotherapy. Perioperative (before and after surgery) Padcev plus pembrolizumab demonstrated a 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant (before surgery) gemcitabine and cisplatin (Hazard Ratio (HR) of 0.53; 95% Confidence Interval (CI), 0.41–0.70; 1-sided p<.0001).The safety profile for perioperative Padcev plus pembrolizumab observed in EV-304 was consistent with prior experience with the combination and there were no new safety signals.
Full Release

Talzenna (talazoparib)
Phase 3 Results
March 2026. Announced positive topline results from the investigational Phase 3 TALAPRO-3 study of Talzenna in combination with Xtandi in people with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The study met its primary endpoint, with Talzenna plus Xtandi demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), compared to placebo plus Xtandi. The results markedly exceeded the pre-specified target hazard ratio of 0.63, with the majority of patients remaining progression-free at the time of analysis. Consistent efficacy benefit was also observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations. The safety of Talzenna plus Xtandi was consistent with the known safety profile of each medicine, and no new safety signals were identified.
Full Release

Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
Product/Project
Milestone
Recent Development Link
atirmociclib
Phase 2 Results
March 2026. Announced positive topline results from the randomized Phase 2 FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) who had received prior cyclin-dependent kinase (CDK) 4/6 inhibitor-based treatment. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS, as assessed by the investigator [HR: 0.60 (95% CI: (0.440, 0.825)), p=0.0007], with a manageable safety profile. Its safety profile was consistent with prior studies, and no new safety signals were identified. These are the first randomized Phase 2 data in HR+ MBC for atirmociclib, an investigational, potential first-in-class CDK4 inhibitor. These findings support Pfizer’s strategy which aims to advance atirmociclib in first-line and early-stage disease, where durable endocrine-based control has the potential to have the greatest impact.
Full Release

Lyme Disease Vaccine Candidate (LB6V / VLA15)
Phase 3 Results
March 2026. Pfizer and Valneva SE announced topline results from the Phase 3 VALOR "Vaccine Against Lyme for Outdoor Recreationists" clinical trial (NCT05477524) of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V, formerly known as VLA15). Results from pre-specified analyses demonstrated efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95% CI 15.8, 93.5) and efficacy of 74.8% from 1-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95% CI 21.7, 93.9). Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95% CI lower bound >20) was not met in the first pre-specified analysis (primary endpoint). The vaccine candidate was well tolerated with no safety concerns identified at time of analysis. Pfizer is planning submissions to regulatory authorities.
Full Release
tilrekimig
Phase 2 Results
March 2026. Announced positive topline results from a Phase 2 study investigating tilrekimig (PF-07275315), a potential first-in-class, investigational trispecific antibody that simultaneously targets interleukin-4 (IL-4), interleukin-13 (IL-13) and thymic stromal lymphopoietin (TSLP), in adults with moderate to severe atopic dermatitis. The study met its primary efficacy endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (≥ 75% reduction in the Eczema Area and Severity Index) at Week 16 across all doses tested, compared to placebo. Tilrekimig was well-tolerated with a favorable safety profile and no dose dependent safety signals; adverse event rates were comparable to placebo. Phase 3 planning for atopic dermatitis is ongoing, with a pivotal study on track to start this year.
Full Release

Corporate Developments
Topic Recent Development Link
Business Development
February 2026. Pfizer and Hangzhou Sciwind Biosciences Co., Ltd. (Sciwind Biosciences) announced a strategic commercialization collaboration in which Pfizer obtained exclusive commercialization rights for Sciwind Biosciences’ glucagon-like peptide 1 (GLP-1) receptor agonist ecnoglutide in Mainland China. Sciwind Biosciences remains the Marketing Authorization Holder and is responsible for research and development, registration, manufacturing and supply of the product. Sciwind Biosciences is eligible to receive an aggregate of up to $495M in upfront, regulatory and sales milestone payments.

Ecnoglutide Injection (Xianweiying(7)) was approved in China on March 6 for long-term weight management in adults with overweight or obesity, as an adjunct to a reduced calorie diet and increased physical activity, and was subsequently launched in China on April 27, 2026.

Full Release
TrumpRx
February 2026. Announced the launch of Pfizer’s participation on TrumpRx.gov providing Americans a wide range of more than 30 medicines at a significant discount off list prices. This effort is part of Pfizer’s broader Most Favored Nation (MFN) agreement with the U.S. government enabling patients to pay lower prices for their prescription medicines, while strengthening America’s role as a global leader in pharmaceutical innovation.
Full ReleaseViiV Healthcare Limited
March 2026. Pfizer completed the exit of its 11.7% investment in ViiV Healthcare Limited and received $1.875 billion in proceeds (or approximately $1.65 billion in cash, net of associated taxes and fees). This transaction will be accounted for in the second quarter of 2026.
N/A
Vyndamax Patent Settlements
April 2026. Pfizer entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the U.S. District Court for the District of Delaware for infringement of patents relating to Vyndamax. These settlements extend the effective U.S. patent expiry date for Vyndamax to June 1, 2031, subject to the outcome of other litigation. Pfizer had previously anticipated a significant decline in U.S. revenues for Vyndamax beginning in 2029 upon patent expiry. As a result of this settlement, revenues are now expected to remain relatively stable from 2028 through mid-2031.
Full Release

(Press release, Pfizer, MAY 5, 2026, View Source [SID1234665126])

Nuvectis Pharma, Inc. Reports First Quarter 2026 Financial Results and Business Highlights

On May 5, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the first quarter of 2026 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "2026 is off to a good start for Nuvectis as we advance the NXP900 Phase 1b clinical program which continues to enroll patients at top sites in the US in both the monotherapy and combination arms of the program." Mr. Bentsur added, "At this year’s AACR (Free AACR Whitepaper) conference held last month, we provided preclinical data supporting the use of NXP900 in combination with sotorasib, a RAS inhibitor, in non-small cell lung cancer (NSCLC). The combination demonstrated clear synergy both in sotorasib-sensitive and sotorasib-resistant NSCLC models."

Mr. Bentsur concluded, "We are excited for what’s ahead in 2026 and expect a preliminary data readout from the NXP900 Phase 1b study in the summer. We continue to operate with financial discipline and remain focused on achieving key clinical development milestones in our NXP900 program in 2026 and beyond."

First Quarter 2026 Financial Results

Cash and cash equivalents were $25.1 million as of March 31, 2026, compared to $31.6 million as of December 31, 2025.

The Company’s net loss was $6.1 million for the three months ended March 31, 2026, compared to $5.3 million for the three months ended March 31, 2025, an increase of $0.8 million. Non-cash stock-based compensation was $1.9 million for the three months ended March 31, 2026 compared to $1.4 million for the three months ended March 31, 2025.

Research and development expenses were $4.1 million for the three months ended March 31, 2026, compared to $3.7 million for the three months ended March 31, 2025, an increase of $0.4 million. The increase was primarily driven by a $0.4 million increase in manufacturing costs, a $0.3 million increase in employee compensation and benefits, and a $0.2 million increase in clinical trial expenses, partially offset by a $0.5 million reduction in license fees and other professional services.

General and administrative expenses were $2.2 million for the three months ended March 31, 2026, compared to $1.9 million for the three months ended March 31, 2025, an increase of $0.3 million. The increase was primarily driven by a $0.2 million increase in professional and consulting services related to public company expenses and a $0.1 million increase in employee compensation and benefits.

Finance income was $0.2 million for the three months ended March 31, 2026 and 2025.

(Press release, Nuvectis Pharma, MAY 5, 2026, View Source [SID1234665125])

Myriad Genetics Reports First Quarter 2026 Financial Results; Reiterates 2026 Financial Guidance Reflecting Ongoing Progress in the Cancer Care Continuum Business

On May 5, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported financial results for its first quarter ended March 31, 2026, and reaffirmed its financial guidance for the full-year 2026.

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"We are seeing strong performance across a number of key areas, including the Cancer Care Continuum as we begin to realize a return on our focused strategy. We have implemented a dedicated hereditary cancer sales force and other key programs designed to support the expected continued growth in germline testing. And with decisive steps taken to address our Prenatal Health business, we expect improved performance in the remainder of 2026," said Sam Raha, President and CEO, Myriad Genetics. "Our limited launch of Precise MRD for breast cancer patients has received positive early feedback and we remain on track with our other planned launches in 2026, as part of our milestone-rich year. We are confident these tests will be important drivers of our growth in 2027 and beyond."

Financial and Operational Highlights
•Test volumes of 385,000 in the first quarter of 2026 were stable year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three Months Ended March 31,
(in thousands) 2026 2025 % Change
Product volumes:
Cancer Care Continuum 96 85 13 %
Prenatal Health 153 173 (12) %
Mental Health 136 127 7 %
Total 385 385 — %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three Months Ended March 31,
(in millions)
2026 2025 % Change
Product revenues:
Cancer Care Continuum $ 120.2 $ 115.6 4 %
Prenatal Health 41.9 49.3 (15) %
Mental Health 38.3 31.0 24 %
Total $ 200.4 $ 195.9 2 %

Product Categories:
Cancer Care Continuum – MyRisk, BRACAnalysis CDx, MyChoice CDx, Prolaris, Precise Tumor, Precise MRD
Prenatal Health – Foresight, Prequel, FirstGene, SneakPeek
Mental Health – GeneSight

•Operating expenses in the first quarter of 2026 were $168.3 million, increasing $5.1 million year-over-year. Adjusted operating expenses in the first quarter of 2026 increased $7.9 million year-over-year to $148.5 million, partially reflecting the company’s progress in its multi-year investment program in key strategic areas.
•Operating loss in the first quarter of 2026 was $30.7 million.

Cash Flow and Liquidity
First quarter 2026 cash flow used in operations was $15.7 million; adjusted operating cash outflow in the first quarter of 2026 was $13.4 million. Capital expenditures and capitalization of internal use software costs totaled $6.5 million in the first quarter 2026 resulting in adjusted free cash flow of $(19.9) million in the first quarter of 2026.

As of the end of the first quarter of 2026, the company had cash and cash equivalents of $124.4 million.

Business Performance and Highlights
Cancer Care Continuum
The Cancer Care Continuum business delivered revenue of $120.2 million in the first quarter of 2026.
•First quarter 2026 hereditary cancer testing revenue increased 5% year-over-year driven by a 14% year-over-year increase in volume.
•First quarter 2026 Prolaris testing revenue grew 3% year-over-year. The company continues to make progress on its first AI-enabled prostate cancer test, in partnership with PATHOMIQ, and expects to launch the test in the second quarter of 2026.
•In April 2026, the company shared new data at a number of annual clinical society meetings, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Society of Gynecologic Oncology (SGO) underscoring Myriad Genetics’ commitment to the Cancer Care Continuum and highlighting its progress in precision oncology. For example, data from one poster presentation showed that Precise MRD testing after adjuvant therapy for ovarian cancer is significantly prognostic of recurrence and that elevated risk was observed even at ctDNA levels detectable only by an ultrasensitive assay. The company believes this data reinforces the scientific strength behind the company’s precision oncology programs and focus on advancing clinically meaningful innovations for patients and providers.
•In April 2026, Myriad Genetics received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of the MyChoice CDx test for prostate cancer patients as a companion diagnostic for Lynparza(olaparib). With this approval, clinicians in Japan can now order the MyChoice CDx test to determine homologous recombination deficiency (HRD) status for patients with ovarian cancer, and BRCA1/2 status for breast and prostate cancers.

Prenatal Health
The Prenatal Health business delivered revenue of $41.9 million in the first quarter of 2026.
•Prenatal testing revenue in the first quarter of 2026 declined 15% year-over-year, as volume decreased 12% year-over-year reflecting a difficult year-over-year comparison as the company continues to engage with customers and address the disruption caused by the Q2 ’25 implementation of the company’s new order management system.
•In April 2026, a national payor updated its medical policy to cover expanded carrier screen tests, like the Company’s Foresight Universal Plus test.
•The multi-site CONNECTOR study, using the company’s FirstGene Multiple Prenatal Screen, continues to see progress in enrollment and the Company expects this study, if successful, to support future commercial launch activities and expand capabilities in prenatal testing.

Mental Health
GeneSight test revenue was $38.3 million in the first quarter of 2026.
•First quarter 2026 revenue grew 24% year-over-year reflecting 7% GeneSight volume growth, and overall improved reimbursement trends.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, strategic realignment, costs related to amortization of intangibles from acquisitions, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and their impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2026 financial guidance*:

(in millions, except percentages)
2026 Guidance
FY 2026 Comments
Revenue $860 – $880
Reiterate the full year 2026 revenue range, reflecting current business trends.

Expect 2H’26 revenue to be greater than 1H’26
Adjusted Gross Margin %**
68% – 69% Gross margins expected to fluctuate quarter to quarter given product mix and pricing trends.
Adjusted EBITDA***
$37 – $49

*
Assumes currency rates as of May 5, 2026.
**
Adjusted Gross Margin is defined as Gross Margin plus non-cash cost of sales, such as amortization of intangible assets and share-based compensation expense, and non-recurring one-time expenses.
***
Adjusted EBITDA is defined as Net income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of goodwill and long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from strategic realignment..

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast
A conference call will be held today, Tuesday, May 5, 2026, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the first quarter of 2026. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at View Source Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

(Press release, Myriad Genetics, MAY 5, 2026, View Source [SID1234665124])

MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors

On May 5, 2026 MimiVax Inc. and Roswell Park Comprehensive Cancer Center reported the launch of a phase 2 clinical trial (NCT06202066) evaluating SurVaxM in combination with temozolomide in patients with progressing neuroendocrine tumors, also known as NETs. The study is being conducted at Roswell Park in Buffalo, New York, under the direction of principal investigator Dr. Jasmeet Kaur.

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The phase 2 study compares the safety and effect of temozolomide combined with SurVaxM to temozolomide alone in patients with metastatic NETs that are progressing.

SurVaxM is a peptide vaccine that has been shown to produce an immune system response against cancer cells that express the protein survivin and may block the growth of new tumor cells. The new clinical trial builds directly on phase 1 findings from NCT03879694, in which SurVaxM was well tolerated in NET patients and demonstrated measurable clinical benefit with elevated antibody responses.

"This phase 2 trial is the result of years of careful, collaborative science between MimiVax, Roswell Park Comprehensive Cancer Center, and the neuroendocrine tumor community," said Michael Ciesielski, PhD, CEO and Co-founder of MimiVax. "NET patients deserve more options, and we are excited to see if SurVaxM can become a new treatment for them."

Neuroendocrine tumors are a rare type of cancer that arise from hormone-producing cells throughout the body, most commonly in the gastrointestinal tract and lungs. Their incidence has increased significantly over the past two decades, with an estimated 28,000 people diagnosed in the U.S. each year. While many NETs grow slowly, metastatic NET disease carries a poor prognosis, and treatment options are limited once patients progress on first-line therapy. Immunotherapy has shown limited efficacy in NETs to date, making the identification of new immunologic targets and approaches important to patient care.

The phase 2 trial builds on Roswell Park’s previous NET research, which demonstrated that survivin, the protein targeted by SurVaxM, is expressed in approximately 52 percent of NET specimens, and that its expression correlates with more aggressive tumor biology and shorter survival. Importantly, the phase 1 study demonstrated that SurVaxM was safe and generated measurable immune responses in NET patients.

"Patients need more options to treat NETs, and the phase 1 data gave us confidence this is a safe, immunologically active approach to try in a larger patient population," said gastrointestinal oncologist Jasmeet Kaur, MD, FACP, study principal investigator and Assistant Professor at Roswell Park. "We are excited to see if the next trial confirms a meaningful clinical benefit that advances patient care."

The initiation of this phase 2 trial comes as MimiVax begins data analysis from its phase 2b SURVIVE trial of SurVaxM in newly diagnosed glioblastoma. SurVaxM is also being evaluated in pediatric brain tumors and multiple myeloma.

"The phase 2 NET study underscores the breadth of cancers in which survivin is a relevant therapeutic target," noted Robert Fenstermaker, MD, Roswell Park Chair Emeritus in Neurosurgery and a co-founder of MimiVax. "Once discarded as too difficult a target, our research into survivin is yielding results that are giving hope to patients with some of the toughest cancer diagnoses."

For more information about this study or other Roswell Park clinical trials, please call 1-800-ROSWELL (1-800-767-9355) or send an e-mail to [email protected] interested in participating in this study may contact Roswell Park Comprehensive Cancer Center at 1-800-ROSWELL (1-800-767-9355) or [email protected]. Additional information is available at clinicaltrials.gov (NCT06202066).

(Press release, MimiVax, MAY 5, 2026, View Source;utm_medium=rss&utm_campaign=mimivax-and-roswell-park-open-phase-2-trial-of-survaxm-for-patients-with-metastatic-neuroendocrine-tumors [SID1234665123])

Jazz Pharmaceuticals Announces First Quarter 2026 Financial Results

On May 5, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the first quarter of 2026 (1Q26).

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"Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "Demand for Xywav remained strong, our rare oncology launches with Modeyso and Zepzelca in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth."

Key First Quarter 2026 Highlights

•Total revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY))
•Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations.
•Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO (Free ASCO Whitepaper) GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status.
•Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.

•Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersomnia (IH) patients.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 15% YoY to $250 million in 1Q26, driven by continued strong demand.
•Announced agreement with Nippon Zoki to commercialize Epidyolex in Japan, following completion of ongoing clinical trials and potential regulatory approval.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales in biliary tract cancer (BTC) were $13 million in 1Q26.
•In April 2026, FDA accepted the zanidatamab sBLA in GEA for a Priority Review, with a PDUFA date of August 25, 2026.
•Submitted HERIZON-GEA-01 data for potential National Comprehensive Cancer Network (NCCN) guideline inclusion.
•HERIZON-GEA-01 data accepted for publication by a top-tier medical journal.
•The second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen is expected in mid-2026.
•Multiple registrational trials of zanidatamab are underway, including in metastatic breast cancer (mBC), supporting a broad development program designed to maximize patient impact and long-term shareholder value.

Modeyso (dordaviprone):
•Modeyso net product sales were $41 million in 1Q26 with ~500 patients having received Modeyso from product launch in August 2025 through the end of the first quarter.
•The company completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $200 million (50% to Jazz).
•Phase 3 ACTION trial remains on track with top-line readout expected late 2026 / early 2027.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 60% YoY to $101 million in 1Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1LM ES-SCLC setting, partially offset by a decline in second line use.
•The company expects second line use to decline throughout the year.
Financial Highlights
Three Months Ended
March 31,
(In millions, except per share amounts) 2026 2025
Total revenues $ 1,068.9 $ 897.8
GAAP net income (loss) $ 293.1 $ (92.5)
Non-GAAP adjusted net income $ 419.5 $ 105.2
GAAP earnings (loss) per share $ 4.43 $ (1.52)
Non-GAAP adjusted earnings per share $ 6.34 $ 1.68

The GAAP net loss and non-GAAP adjusted net income for 1Q25 included an expense of $172 million related to Xyrem antitrust litigation settlements, which impacted our GAAP and non-GAAP results by $146 million (net of tax of $26 million), or $2.38 per share on a GAAP basis and $2.34 per share on a non-GAAP adjusted basis.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

(Press release, Jazz Pharmaceuticals, MAY 5, 2026, View Source [SID1234665121])