Pfizer Reports Solid Full-Year 2025 Results And Reaffirms 2026 Guidance

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])

Independent Multi-Vendor Study Validates BostonGene’s AI for Precision HER2 Scoring

On February 3, 2025 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported another major independent validation of its AI and machine learning (ML) capabilities in a landmark blinded, multi-vendor HER2 benchmarking study. The results, published in the Modern Pathology article, "Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images" were conducted in collaboration with Friends of Cancer Research and supported by leading global pharmaceutical companies and patient advocacy stakeholders.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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This publication adds to a growing body of external evidence validating the technical rigor, performance, and real-world relevance of BostonGene’s AI-driven approach. By evaluating algorithmic and AI-based methods under an independent framework, the study mirrors the stringent benchmarks that drug developers and regulators increasingly use to assess advanced analytics technologies. Such multi-site validation is critical for increasing confidence in AI-driven biomarkers and de-risking regulatory, clinical, and companion diagnostic development. These blinded, ecosystem level evaluations confirm BostonGene’s position among a select group of companies operating at the highest threshold of scientific and technical excellence for clinical-grade AI.

BostonGene’s AI and machine learning capabilities are built on a foundation model of cancer and immune system that integrates multiomic, RNA, DNA, TCR, spatial, and clinical data at scale. This multidimensional approach enables deep characterization of tumors and the immune microenvironment, supporting critical decisions across the drug development lifecycle, from early-stage target discovery to research to patient stratification and trial optimization.

As HER2 remains one of the most critical biomarkers in oncology, the terminology and evaluation frameworks outlined in this publication are expected to set the benchmark for how AI and ML tools are assessed by drug developers going forward. BostonGene’s inclusion in this initiative reflects the industry’s sustained confidence in the company’s ability to deliver transparent, reproducible and clinically meaningful AI.

"This is not an isolated result," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We continue to see independent, external validation of the AI and ML algorithms that power our foundation model. These blinded, real-world evaluations provide the high-stakes certainty that drug developers trust when accelerating life-saving therapies."

Pharmaceutical organizations supporting the study included AstraZeneca, Bristol Myers Squibb, Amgen, Merck, and GlaxoSmithKline. BostonGene continues to partner with these and other leading pharmaceutical companies on strategic programs where its AI-driven insights directly inform biomarker strategy and clinical execution.

(Press release, BostonGene, FEB 3, 2026, View Source [SID1234662445])

1stOncologyWeekly 3rd February 2026

Your roundup of the top oncology news. 1stOncologyWeekly: February 3, 2026

"1stOncologyWeekly:

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Agreement / Collaboration / M&A
HanchorBio and WuXi Biologics Enter Strategic Partnership to Advance Next-Generation Bi-and Multi-Functional Fusion Protein Pipeline
MS Pharma Group Signs Exclusive Biosimilars Partnership Agreement with Hetero
StarkAge Therapeutics Announces Research Collaboration with Gustave Roussy to Advance Senolytic Therapies in Digestive Cancers
Insilico Medicine and Qilu Pharmaceutical Reach Near $120 Million Drug Development Collaboration to Accelerate Novel Cardiometabolic Therapies
Boehringer Ingelheim and Simcere partner to advance a dual-target antibody treatment to address unmet needs in inflammatory bowel disease
Defence Therapeutics Expands Collaboration With Canadian Nuclear Laboratories To Accelerate Its Proprietary Radiopharmaceutical Pipeline
Physiomics Awarded New Contract by Numab Therapeutic
InSysBio to announce a new collaborative project with BeOne Medicines
WuXi Biologics and Sinorda Biomedicine Enter Strategic Collaboration to Accelerate Development and Manufacturing of Innovative Bispecific Antibody
Repare Announces Completion of Acquisition by XenoTherapeutics, Inc.
Accent Therapeutics to Utilize Inocras’ CancerVision and MRDVision Platforms in Phase 1/2 ATX-295 Clinical Study
Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer
RECORDATI ANNOUNCES STRATEGIC COLLABORATION WITH MODERNA TO DEVELOP AND COMMERCIALIZE WORLDWIDE mRNA 3927 FOR THE TREATMENT OF PROPIONIC ACIDEMIA
Immuto Scientific and University of Wisconsin–Madison Announce Collaboration to Advance Discovery of Novel Cancer Targets
Illumina completes acquisition of SomaLogic
Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer
Funding
BioMarin Announces Proposed Private Offering of Senior Notes and Syndication of New Senior Secured Term Loan Facility
Primmune Therapeutics Announces Additional Close of Series B Financing
Fortitude Biomedicines Launches With $13M in Financing to Advance Novel Antibody-based Therapies for Treatment of Autoimmune Diseases and Cancer
AIM ImmunoTech Announces Changes to Key Dates and Terms Related to Announced Rights Offering
CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer
Rakovina Therapeutics Announces Corporate Update Including up to $1.6 Million in New Financing, Leadership Appointments and Debt Restructuring
Altimmune Announces Pricing of $75 Million Registered Direct Offering of Common Stock
BridGene Biosciences Raises $28 Million in Series B+ Financing to Accelerate Clinical Development of BGC-515 and Platform Expansion
Enveric Biosciences Announces $1.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
Enveric Biosciences Announces Closing of $1.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules
CraniUS Therapeutics Closes $20 Million Series B Round to Advance NeuroPASS Platform Towards Future Commercialization
Aprea Therapeutics Announces $5.6 Million Private Placement Priced At-The-Market Under Nasdaq Rules
BioMarin Announces Pricing of Private Offering of Senior Notes and Completion of
Syndication of New Senior Secured Term Loan Facility
LEXICON ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK
Altimmune Announces Closing of $75 Million Registered Direct Offering of Common Stock
ALX Oncology Announces Pricing of Underwritten Offering
Submission / Acceptance / Opinion / Approval
Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)
Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma
Chugai Files for Additional Indication of Tecentriq for the Treatment of Adjuvant Therapy for MRD-Positive Bladder Cancer
DARZALEX FASPRO-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma
Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201
Shorla Oncology Announces U.S. FDA Approval of Larger Vial Size for Nelarabine Intravenous Administration for the Treatment of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma
Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy in Treatment of Patients with EGFRm NSCLC Post-TKI Therapy
Incyte Announces Positive CHMP Opinion for Zynyz (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)
Clinical Trial Results
Phio Pharmaceuticals Announces Participation in Third Annual DealFlow Discovery Conference
Kazia Therapeutics Reports Encouraging Preliminary Clinical Responses in Ongoing Phase 1b Study of Paxalisib in Late-Stage Metastatic Triple-Negative Breast Cancer
Calidi Biotherapeutics Provides Corporate Update and Key Value Drivers for 2026
PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI
Alpha Tau Issues Letter to Shareholders: Five Concurrent Trials in the U.S. with Multiple Significant Value-Driving Milestones Ahead
Aprea Therapeutics Announces Early Clinical Proof-Of-Concept in the Ongoing ACESOT-1051 Dose-Escalation Trial Evaluating WEE1 Inhibitor APR-1051, Including Partial Response Observed on First Scan
New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology’s Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer
Trial Initiation / Enrollment
First Site Activated and First Patient Randomised in new brain cancer study VIGOR – EORTC‑2427‑BTG
CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer
Four additional sites open for recruitment in Oncoinvent’s Phase 2 trial
Revolution Medicines Doses First Patient in Clinical Trial Evaluating RMC-5127, a RAS(ON) G12V-Selective Inhibitor
Preclinical
New publication in Cell Death & Disease demonstrates the versatility and safety of Vartumab for cytotoxic payload delivery in oncology
Preclinical Results of the Anti-CTLA-4 Switch Antibody ROSE12 Published in the Journal for ImmunoTherapy of Cancer
ME THERAPEUTICS SCIETIFIC AND CORPORATE UPDATE
Kazia Therapeutics Announces Compelling Preclinical and Translational Data for Nuclear PD-L1 Degrader (NDL2)
Biomarker
Tempus Reveals Its AI-Driven IPS Test More Accurately Predicts Immunotherapy Benefit Compared to Conventional Biomarkers
Caris Life Sciences’ Real-World Data Uncovers Metastatic Breast Cancer Patient Responses and Resistance to Trastuzumab Deruxtecan
GRAIL Submits FDA Premarket Approval Application for the Galleri Multi-Cancer Early Detection Test
Patents
Akari Therapeutics Files Key Patent and Unveils Second ADC Program AKTX-102 Targeting CEACAM5 Expressing Solid Tumors
NUCLIDIUM Announces Issuance of New U.S. Patent Covering its 61Cu-based Radiodiagnostic Program for PSMA-positive Prostate Cancer
Anixa Biosciences Receives Notice of Allowance from Mexican Institute of Industrial Property (IMPI) for Patent Covering Breast Cancer Vaccine Technology
AB Science receives notice of allowance for US patent covering masitinib in the treatment of metastatic castrate resistant prostate cancer
Abstract / Conference
QureBio Ltd. to Present at ASCO (Free ASCO Whitepaper) 2026 its Q-1802 Phase II Clinical Results
R&D Day / Investment Presentation
Delcath Systems to Participate at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Personalis to Participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Adicet Bio to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Other
Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

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Prelude Therapeutics Receives FDA Clearance of Investigational New Drug Application (IND) for PRT12396, a Mutant-selective JAK2V617F Inhibitor

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])

Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer

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])