On February 3, 2026 AstraZeneca and Daiichi Sankyo reported that supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026.

The sBLA is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumours do not express PD-L1 as well as patients with PD-L1-expressing tumours who cannot receive immunotherapy due to other factors. Chemotherapy remains the only approved 1st-line treatment for these patients.1,2

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial – the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease. The Priority Review of our submission underscores the impact of these results and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "Datroway potentially could be the first medicine approved in the 1st-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option. We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer."

The sBLA is based on results from the TROPION-Breast02 Phase III trial which showed Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust and durable treatment responses, including an objective response rate (ORR) of 62.5% and duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and DoR of 7.1 months with chemotherapy. These results were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

Additional regulatory submissions for Datroway in breast and lung cancer are underway globally.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025.5,6 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.7-9 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.7,10,11

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.7 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.7 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.12,13 However, for the approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the only approved 1st-line treatment.1,2

TROP2 is a protein broadly expressed in several solid tumours including TNBC.14 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.15,16

TROPION-Breast02

TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, DoR, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway

Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population.

Datroway clinical development programme

A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

(Press release, AstraZeneca, FEB 3, 2026, View Source [SID1234662433])

On February 3, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal third quarter ended December 31, 2025 and provided a business update.

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The Company’s Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well underway to support a potential launch, if approved.

The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into to the first quarter of 2027.

"We have been engaged with the FDA in the review of the BLA resubmission for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.
Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO (Free ESMO Whitepaper) Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events.
Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO (Free ESMO Whitepaper) featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025.
ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.
RP2

REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval.
Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab.
Financial Highlights

Cash Position: As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.
R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024.
About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, FEB 3, 2026, View Source [SID1234662432])

On February 3, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608) in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

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"Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients."

The FDA’s BTD is designed to accelerate the development and review of therapies for serious conditions when early clinical evidence suggests the potential for substantial improvement over available treatments. BTD provides eligibility for all Fast Track designation features, along with enhanced FDA guidance on development and increased engagement with senior FDA leadership.

BTD for zovegalisib was supported by clinical data generated to date from the Phase 1/2 ReDiscover trial, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant, and in combination with fulvestrant and CDK inhibitors. Specifically, the application included data across all PIK3CA mutations (kinase and non-kinase) for two doses with comparable exposures: 600mg BID fasted (N=52) and 400mg BID fed (N=57), the dose being used in the ongoing Phase 3 trial, ReDiscover-2.

Safety and efficacy from the 600mg BID fasted data referenced above were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, with an additional efficacy subgroup analysis presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).

Data for the 400mg BID fed (the Phase 3 dose) will be presented for the first time at ESMO (Free ESMO Whitepaper) Targeted Anticancer Congress 2026 on Monday, March 16.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+, HER2- breast cancer with a PI3Kα mutation per year in the United States and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.

About PIK3CA-mutated, HR+/HER2- Advanced Breast Cancer

Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common subtype of breast cancer. Approximately 40% of patients with HR+/HER2- breast cancer harbor activating mutations in the PIK3CA gene, which drive tumor growth and are associated with poorer outcomes compared to patients without these mutations. Despite CDK4/6 inhibitors plus endocrine therapy being the standard of care in advanced disease, many patients with PIK3CA-mutated tumors have poorer outcomes and there are no approved regimens incorporating a pan-mutant selective PI3Kα inhibitor.

(Press release, Relay Therapeutics, FEB 3, 2026, View Source [SID1234662431])

On February 3, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT12396, a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms (MPNs). The Company anticipates dosing the first patient by Q2 of 2026.

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"The FDA’s clearance of our IND for PRT12396 marks a pivotal first milestone in the strategic transformation and development focus on our JAK2 and KAT6 programs that we outlined last quarter," stated Kris Vaddi, Chief Executive Officer of Prelude. "This achievement demonstrates our ability to translate high-quality science rapidly into clinical progress and our clear focus on executing these programs that represent the potential to reshape the treatment landscape for the target patient populations. We look forward to advancing PRT12396 into the phase 1 study in patients with polycythemia vera and myelofibrosis in parallel."

The Phase 1 study of PRT12396 is an open-label, multi-center, safety and efficacy study in patients with high-risk polycythemia vera (PV) and intermediate and high-risk myelofibrosis (MF). The primary endpoints of the study include safety, efficacy and PK profile.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

(Press release, Prelude Therapeutics, FEB 3, 2026, View Source [SID1234662430])

On February 3, 2026 Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2025 and reaffirmed its full-year 2026 financial guidance(1) provided on December 16, 2025.

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:
"With excellent execution in 2025, we delivered a solid financial performance and strengthened Pfizer’s foundation for future growth. Looking ahead, 2026 will be an important year rich in key catalysts, including our expectation for approximately 20 key pivotal study starts, and continued strategic investment to maximize our opportunities for industry-leading growth at the end of the decade."
David Denton, CFO and EVP of Pfizer:
"I’m pleased with our solid financial results in 2025. With focused commercial execution, we delivered full-year operational revenue growth of 6% for our non-COVID portfolio, and our continued financial discipline drove strong EPS performance. Today, we are reaffirming our full-year 2026 financial guidance."
OVERALL RESULTS
■Full-Year 2025 Revenues of $62.6 Billion, Reflecting a 2% Year-over-Year Operational Decline
–Excluding Contributions from Paxlovid and Comirnaty, Revenues Grew 6% Operationally
■Full-Year 2025 Reported(2) Diluted EPS of $1.36 and Adjusted(3) Diluted EPS of $3.22
■Fourth-Quarter 2025 Revenues of $17.6 Billion, Representing a 3% Year-over-Year Operational Decline
–Excluding Contributions from Paxlovid and Comirnaty, Revenues Grew 9% Operationally
■Fourth-Quarter 2025 Reported(2) Diluted Loss Per Share (LPS) of $(0.29) and Adjusted(3) Diluted EPS of $0.66
■Reaffirms All Components of Full-Year 2026 Financial Guidance(1), including Revenues in a Range of $59.5 to $62.5 Billion and Adjusted(3) Diluted EPS in a Range of $2.80 to $3.00

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(4).
Results for the fourth quarter and full year of 2025 and 2024(5) are summarized below.
($ in millions, except per share amounts)
Fourth-Quarter Full-Year
2025 2024
% Change
2025 2024
% Change
Revenues $ 17,557 $ 17,763 (1%) $ 62,579 $ 63,627 (2%)
Reported(2) Net Income/(Loss)
(1,648) 410 * 7,771 8,031 (3%)
Reported(2) Diluted EPS/(LPS)
(0.29) 0.07 * 1.36 1.41 (3%)
Adjusted(3) Income
3,786 3,592 5% 18,406 17,716 4%
Adjusted(3) Diluted EPS
0.66 0.63 5% 3.22 3.11 4%
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Fourth-Quarter Full-Year
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 17,144 $ 17,413 (2%) (3%) $ 61,199 $ 62,400 (2%) (2%)
Pfizer CentreOne (PC1) 409 325 26% 22% 1,338 1,146 17% 15%
Pfizer Ignite 4 26 (83%) (83%) 41 82 (50%) (50%)
TOTAL REVENUES $ 17,557 $ 17,763 (1%) (3%) $ 62,579 $ 63,627 (2%) (2%)

2026 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2026 Revenue guidance in a range of $59.5 to $62.5 billion and Adjusted(3) diluted EPS guidance(1) in a range of $2.80 to $3.00.
■The reaffirmed 2026 Revenue guidance reflects the expectation of approximately $5 billion in revenues from our COVID-19 products and an expected year-over-year negative revenue impact of approximately $1.5 billion due to certain products experiencing loss of exclusivity (LOE)(1).
■2026 Adjusted(3) diluted EPS guidance primarily reflects our expected revenues, anticipated stable gross and operating margins versus full-year 2025, and an anticipated higher tax rate on Adjusted(3) income versus full-year 2025. Additionally, our guidance reflects our expectation for a continued focus on prioritization in key therapeutic areas as well as our plan to start approximately 20 key pivotal trials in 2026, including ten pivotal trials for ultra-long-acting obesity assets acquired from Metsera and four pivotal trials for PF-08634404 (a PD-1 x VEGF bispecific antibody in-licensed from 3SBio).
■The company’s guidance reflects the anticipated unfavorable impact of Most-Favored-Nation drug pricing and TrumpRx.
■The company’s guidance includes the anticipated impact of currently imposed tariffs.
Revenues
$59.5 to $62.5 billion
Adjusted(3) SI&A Expenses
$12.5 to $13.5 billion
Adjusted(3) R&D Expenses
$10.5 to $11.5 billion
Effective Tax Rate on Adjusted(3) Income
Approximately 15.0%
Adjusted(3) Diluted EPS
$2.80 to $3.00

CAPITAL ALLOCATION
In 2025, 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:
•$10.4 billion invested in internal research and development projects, and
•Approximately $8.8 billion invested in business development transactions, primarily reflecting the Metsera acquisition and the 3SBio in-licensing deal.
▪Returning capital directly to shareholders through $9.8 billion of cash dividends, or $1.72 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) maintaining and, over the long term, growing our dividend, (ii) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases. 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 were completed in 2025. As of February 3, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026.
For the fourth quarter of 2025, basic weighted-average shares outstanding of 5,686 million were used to calculate Reported(2) LPS and diluted weighted-average shares outstanding of 5,722 million were used to calculate Adjusted(3) diluted EPS.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2025 vs. Fourth-Quarter 2024)
Fourth-quarter 2025 revenues totaled $17.6 billion, a decrease of $206 million, or 1%, compared to the prior-year quarter, reflecting an operational decrease of $484 million, or 3%, and a favorable impact of foreign exchange of $278 million. The operational decrease was primarily driven by a year-over-year decline in COVID-19 product revenues, partially offset by an increase in revenues for Abrysvo, Oncology biosimilars, Eliquis, the Prevnar family, the Vyndaqel family, and several other products across categories. Excluding contributions from Comirnaty and Paxlovid, revenues for the fourth quarter grew 9% operationally.
Fourth-quarter 2025 operational revenue reflected higher revenues primarily for:
▪Abrysvo globally, up 136% (or up $270 million) operationally, driven primarily by launch uptake for both the adult and maternal indications in certain international markets, as well as favorable net price and market share for the adult indication in the U.S.; partially offset by lower vaccination rates for the older adult indication in the U.S. following an updated recommendation by the Advisory Committee on Immunization Practices;
▪Oncology biosimilars globally, up 76% operationally, driven primarily by favorable net price in the U.S.;
▪Eliquis globally, up 8% operationally, driven primarily by higher demand globally and, as anticipated, favorable net price in the U.S. as a result of the year-over-year impact of the elimination of the coverage gap as part of the IRA Medicare Part D Redesign; partially offset by a reduction in sales due to lower inventory in the U.S. distribution channel related to year-end buying patterns, as well as generic entry and price erosion in certain international markets;
▪Prevnar family globally, up 8% operationally, driven primarily by strong uptake of the adult indication in certain international markets, coupled with continued uptake of the adult indication in the U.S. as a result of strong demand following the U.S. Centers for Disease Control and Prevention (CDC) recommendation for ages 50-64; partially offset by lower market share in the U.S. and timing of shipments in certain international markets;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 7% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, as well as improved patient affordability in the U.S.; partially offset by lower net price in the U.S. due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign and, to a lesser extent, new payer contracts with reduced pricing;
▪Lorbrena globally, up 45% 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, partially offset by lower net price in the U.S. mainly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D redesign; and
▪Padcev globally, up 15% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC);
more than offset primarily by lower revenues for:
▪Comirnaty globally, down 35% operationally, driven primarily by a decline in international markets from both lower contractual deliveries and lower vaccination rates in commercial markets, as well as lower utilization in the U.S. resulting from a narrower recommendation for vaccination; and
▪Paxlovid globally, down 70% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower international government purchases; partially offset by higher net price in the U.S. following transition from the U.S. government agreement.
GAAP Reported(2) Statement of Operations Highlights
SELECTED REPORTED(2) COSTS AND EXPENSES
($ in millions) Fourth-Quarter Full-Year
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Cost of Sales(2)
$ 5,272 $ 5,909 (11%) (14%) $ 16,067 $ 17,851 (10%) (12%)
Percent of Revenues
30.0 % 33.3 % N/A N/A 25.7 % 28.1 % N/A N/A
SI&A Expenses(2)
4,162 4,274 (3%) (3%) 13,794 14,730 (6%) (7%)
R&D Expenses(2)
3,206 3,035 6% 5% 10,437 10,822 (4%) (4%)
Acquired IPR&D Expenses(2)
212 88 * * 1,613 108 * *
Other (Income)/Deductions—net(2)
4,514 2,358 91% 94% 6,724 4,388 53% 55%
Effective Tax Rate on Reported(2) Income/(Loss)
0.1 % * (3.5 %) (0.4%)

Fourth-quarter 2025 Cost of Sales(2) as a percentage of revenues decreased by 3.2 percentage points compared to the prior-year quarter, primarily driven by (i) a favorable change in sales mix including lower sales of Comirnaty, and (ii) lower amortization from the step-up of acquired inventory; partially offset by (iii) an unfavorable impact of foreign exchange and (iv) a lower favorable revision of our estimate of accrued royalties in the fourth quarter of 2025 compared to the prior-year quarter.
Fourth-quarter 2025 SI&A Expenses(2) decreased 3% operationally compared to the prior-year quarter, primarily reflecting focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions, partially offset by an increase in liabilities payable to participants of our supplemental savings plan.
Fourth-quarter 2025 R&D Expenses(2) increased 5% operationally compared to the prior-year quarter, driven primarily by an increase in spending in oncology and obesity product candidates, partially offset by a net decrease in spending due to pipeline focus and optimization including the expansion of our digital capabilities.
Fourth-quarter 2025 Acquired In-Process R&D Expenses(2) increased $124 million compared to the prior-year quarter, driven primarily by a $150 million charge related to an in-licensing agreement with YaoPharma.
The unfavorable period-over-period change in Other (income)/deductions—net(2) of $2.2 billion for the fourth quarter of 2025, compared to the prior-year quarter, was driven primarily by (i) higher intangible asset impairment charges in the fourth quarter of 2025, (ii) lower net gains on equity securities and (iii) the non-recurrence of gains on the partial sale of our previous investment in Haleon plc (Haleon) equity in the fourth quarter of 2024; partially offset by (iv) net periodic benefit credits associated with pension and postretirement plans incurred in the fourth quarter of 2025 versus net periodic benefit costs incurred in the fourth quarter of 2024. Included in Other (income)/deductions—net(2) are total non-cash intangible asset impairment charges of $4.4 billion that were taken in the fourth quarter of 2025 due to changes in development plans and updated long-range commercial forecasts.
Pfizer’s effective tax rate on Reported(2) loss for the fourth quarter of 2025 reflects the jurisdictional mix of earnings as well as resolutions with tax authorities.

RECENT NOTABLE DEVELOPMENTS (Since November 4, 2025)
Product Developments
Product/Project

Milestone

Recent Development
Braftovi
(encorafenib)
Phase 3 Results
January 2026. Announced positive results from Cohort 3, a separate, investigational randomized cohort of the pivotal BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of analysis, the Braftovi combination regimen with FOLFIRI and cetuximab demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR), as assessed by BICR, compared to patients receiving standard-of-care treatment FOLFIRI with or without bevacizumab (64.4% vs 39.2%, odds ratio =2.76, p=0.001). The safety profile of Braftovi in combination with cetuximab and FOLFIRI was consistent with the known safety profile of each respective agent.
Full Release
Hympavzi (marstacimab)
Phase 3 Results
December 2025. Announced detailed results from the Phase 3 BASIS study (NCT03938792) evaluating Hympavzi for adults and adolescents living with hemophilia A or B with inhibitors that demonstrated the superiority of investigational use of Hympavzi in improving key bleeding outcomes compared to on-demand (OD) treatment with bypassing agents.

Product/Project
Milestone
Recent Development Link
Padcev (enfortumab vedotin)
Phase 3 Results
December 2025. Pfizer and Astellas Pharma Inc. (Astellas)
announced positive topline results from an interim analysis of the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) for Padcev in combination with pembrolizumab. The pivotal study is evaluating the combination as neoadjuvant and adjuvant treatment (before and after surgery) versus standard of care neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint. An additional secondary endpoint of pathologic complete response (pCR) rate for neoadjuvant Padcev plus pembrolizumab versus neoadjuvant chemotherapy was also met, and a clinically meaningful and statistically significant improvement was observed. The safety profile for Padcev plus pembrolizumab was consistent with the known profile of the treatment regimen.
Full Release
Regulatory
December 2025. Astellas announced the European Medicines Agency (EMA) validated for review a Type II variation application for Padcev in combination with pembrolizumab, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with MIBC who are ineligible for cisplatin-containing chemotherapy. The EMA’s Committee for Medicinal Products for Human Use and subsequently the European Commission are expected to share their opinion and decision in 2026.
Full Release
Regulatory
November 2025. Pfizer and Astellas announced the U.S. Food and Drug Administration (FDA) approved Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as neoadjuvant treatment and then continued after cystectomy (surgery) as adjuvant treatment for adult patients with MIBC who are ineligible for cisplatin-containing chemotherapy. The approval of this perioperative (before and after surgery) treatment was based on results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905).
Full Release
Tukysa (tucatinib)
Phase 3 Results
December 2025. Announced detailed results from the Phase 3 HER2CLIMB-05 trial of Tukysa as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction, in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with Tukysa, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, as assessed by the investigator (hazard ratio [HR] of 0.641, 95% confidence interval (CI): 0.514-0.799; 2-sided p<0.0001). The combination demonstrated a manageable safety profile as a first-line maintenance therapy.

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
Ultra-Long-Acting GLP-1 (PF’3944 / MET-097i)
Phase 2b Results
February 2026. Announced positive topline results from the Phase 2b VESPER-3 study investigating monthly maintenance dosing of the fully-biased, ultra-long-acting, injectable GLP-1 receptor agonist PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes. The study met its primary endpoint of statistically significant weight reduction at 28 weeks and demonstrated a competitive tolerability profile. Additionally, weight loss continued after the pre-planned switch from weekly to monthly dosing, with no plateau observed at 28 weeks. Detailed results from VESPER-3 will be presented on June 6, 2026 at the 86th Scientific Sessions of the American Diabetes Association.
Full Release

Corporate Developments
Topic Recent Development
Business Development
December 2025. Announced an exclusive global collaboration and in-license agreement with YaoPharma, a leading innovation-driven global healthcare company, for the development, manufacturing and commercialization of YP05002, a small molecule glucagon-like peptide 1 (GLP-1) receptor agonist currently in Phase 1 development for chronic weight management. Under the terms of the agreement, YaoPharma will complete an ongoing YP05002 Phase 1 clinical trial and granted Pfizer an exclusive license to further develop, manufacture and commercialize YP05002 worldwide. YaoPharma received an upfront payment of $150 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $1.935 billion, as well as tiered royalties on sales, if approved.
Full Release
November 2025. Announced the completion of Pfizer’s acquisition of all outstanding shares of common stock of Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases, for $65.60 in cash per Metsera share, representing an enterprise value of approximately $7.0 billion. Additionally, Metsera shareholders were granted a contingent value right (CVR) of up to $20.65 per share of Metsera stock in potential additional payments tied to the achievement of three specified clinical and regulatory milestones.
Full Release
ViiV Healthcare Limited
January 2026. Pfizer reached an agreement with GSK plc and Shionogi & Co., Ltd to exit its 11.7% investment in ViiV Healthcare Limited. Under the terms of the agreement, Pfizer will receive $1.875 billion in cash. Completion of the transaction is expected to occur in the first quarter of 2026, subject to certain regulatory clearances in relevant markets.
N/A

PFIZER TO HOST CONFERENCE CALL
Pfizer will host a live conference call and webcast today, February 3, 2026, at 10:00 AM EST. To access the live conference call, the fourth-quarter 2025 earnings presentation, and the accompanying prepared remarks from management, visit our website at pfizer.com/investors.
You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is "10856".
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

(Press release, Pfizer, FEB 3, 2026, View Source [SID1234662429])