Pfizer Inc.

Pfizer Reports Strong Third-Quarter 2026 Results And Raises 2026 Guidance

Pfizer reported Q3 2026 revenue of $16.6 billion, roughly flat year-over-year, with Adjusted diluted EPS of $0.87 (flat YoY) and GAAP diluted EPS of $0.56. Underlying performance was strong outside COVID: excluding Comirnaty and Paxlovid, revenues grew 7% operationally, and launched and acquired products grew 32%, led by Eliquis (+25%), Padcev (+55%), and Lorbrena (+43%). Pfizer raised FY26 revenue guidance by $1.5 billion at the midpoint to $62.0-$64.0 billion and lifted Adjusted diluted EPS guidance to $2.95-$3.05, citing strong year-to-date performance and cost improvement initiatives. Cecile Guegan was appointed CFO effective November 1, 2026; the quarter also included a one-time $650 million Acquired IPR&D charge tied to the Innovent Biologics in-licensing agreement, an approximately $0.10 EPS headwind.

•5d ago

Pfizer’s ELREXFIO Outperforms Standard Regimens and Meets Primary Endpoint in Phase 3 Study in Relapsed or Refractory Multiple Myeloma

Pfizer's Phase 3 MagnetisMM-32 trial met its primary endpoint, with ELREXFIO (elranatamab) monotherapy showing a statistically significant and clinically meaningful progression-free survival benefit versus investigator's choice of three standard regimens in relapsed/refractory multiple myeloma after anti-CD38 therapy and lenalidomide. Median PFS was not yet reached, with more than 75% of patients progression-free at analysis and an estimated 68% PFS at 18 months; the safety profile was consistent with the known label with no new safety signals. Pfizer plans to submit the data to global health authorities, supporting a potential label expansion into earlier lines of RRMM for the already-marketed BCMA bispecific (approved in 35+ countries).

•12d ago

Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting

The FDA expanded approval of Pfizer's TALZENNA plus XTANDI to HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive (mHSPC) prostate cancer, moving the combination into an earlier line of treatment. The approval rests on the Phase 3 TALAPRO-3 study of 599 patients, which showed a 52% reduction in the risk of radiographic progression or death (HR 0.48, p<0.0001) and 77% progression-free at three years. XTANDI is jointly commercialized with Astellas in the U.S.; an EMA application for the same expanded indication is under review with additional global filings underway.

•13d ago

Pfizer's 25-Valent Pediatric Pneumococcal Conjugate Vaccine Candidate Shows Robust Phase 2 Data at IDWeek 2026

Pfizer presented Phase 2 data at IDWeek 2026 showing its 25-valent pediatric pneumococcal vaccine candidate (25vPnC) elicited robust immune responses against all 25 serotypes in infants, with safety comparable to PREVNAR 20. The candidate showed an enhanced response against the historically challenging serotype 3 — GMCs 8.8-fold higher than PREVNAR 20 after Dose 3 and roughly 15-fold higher after Dose 4 — and covered five new serotypes that account for an additional ~30% of pediatric invasive pneumococcal disease in the U.S. The data support an ongoing Phase 3 program of three studies with up to 6,830 participants; if successful, 25vPnC could cover serotypes responsible for approximately 84% of U.S. pediatric IPD cases, protecting the PREVNAR franchise against competitive erosion.

•15d ago

Pfizer Showcases Clinical Advancements Across Infectious Diseases at IDWeek 2026

Pfizer will present data from 57 abstracts, including 12 oral presentations, across its infectious disease pipeline at IDWeek 2026 in Washington, D.C., October 21-24. Key pipeline updates include Phase 2 data for the 25-valent pediatric pneumococcal vaccine candidate (25vPnC) versus PREVNAR 20, Phase 3 VALOR study results for the LB6V Lyme vaccine candidate with BioNTech-partnered COMIRNATY and Valneva-partnered programs also featured, and an EMA review already underway for the Lyme MAA. Real-world evidence supports marketed products ABRYSVO, PREVNAR 20, and PENBRAYA, reinforcing current standards of care while next-generation vaccine candidates advance in late-stage development.

•25d ago

Pfizer’s TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer

The FDA approved Pfizer's TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab as a front-line, chemotherapy-free maintenance treatment for adults with HER2+ metastatic breast cancer following induction therapy. The approval is based on the Phase 3 HER2CLIMB-05 trial, which showed median PFS of 24.9 months versus 16.3 months with placebo (HR 0.64, p<0.0001), a more than 50% improvement in median PFS. Safety was broadly consistent with TUKYSA's known profile, though the label carries a boxed warning for severe hepatotoxicity, including one fatal drug-induced liver injury case in the trial. The label expansion moves TUKYSA from second-line into the earlier front-line maintenance setting, extending its commercial runway within Pfizer's breast cancer franchise.

•1mo ago

Pfizer’s LITFULO Significantly Improved Facial and Total Body Repigmentation in Patients with Nonsegmental Vitiligo

Pfizer presented Phase 3 TRANQUILLO results showing LITFULO significantly improved facial and total body repigmentation in nonsegmental vitiligo at Week 52 versus placebo, with both co-primary endpoints met. F-VASI75 was achieved by 21.86% (100 mg) and 12.47% (50 mg) of patients versus roughly 2.4% on placebo, and the safety profile was consistent with the drug's established alopecia areata label with no new safety signals. Pfizer plans to submit the data to the FDA and EMA, positioning LITFULO as a potential first oral systemic therapy for NSV and expanding the drug's lifecycle beyond alopecia areata.

•1mo ago

Pfizer's Tilrekimig Shows Significant Skin Clearance in Phase 2 Atopic Dermatitis Study

Pfizer's investigational trispecific antibody tilrekimig met the primary endpoint in a Phase 2 atopic dermatitis study, with EASI-75 response rates of 58.5%-62.5% across leading doses versus 9.1%-19.9% for placebo at Week 16. The drug blocks IL-4, IL-13, and TSLP concurrently, and its ~37-day half-life is expected to support monthly dosing. No serious drug-related adverse events were reported, with TEAE rates comparable to placebo in Stage 2. Pfizer has already initiated Phase 3 trials in atopic dermatitis (including one with dupilumab as an active comparator) and asthma, plus a Phase 2b/3 COPD study, positioning tilrekimig as a next-generation biologic challenger to standard-of-care therapies.

•1mo ago

Pfizer Advances Today’s Cancer Care and Tomorrow's Potential Breakthroughs at ESMO

Pfizer will present data from 45 abstracts, including 11 oral presentations, at the ESMO Congress on October 23-27, 2026 in Madrid. Key pipeline assets include atirmociclib (Phase 2 FOURLIGHT-1 in HR+/HER2- metastatic breast cancer with Phase 3s ongoing/planned), late-breaking Phase 3 overall survival data for sigvotatug vedotin in NSCLC, and updated Phase 2 data for the PD-1/VEGF bispecific tivunatamig in first-line NSCLC. Established medicines PADCEV, TALZENNA, BRAFTOVI and MEKTOVI also feature, with a TALZENNA plus XTANDI sNDA in metastatic prostate cancer currently under FDA Priority Review.

•1mo ago

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

Pfizer and BioNTech received FDA approval for their 2026-2027 XFG-adapted COVID-19 vaccine for adults 65 and older and high-risk individuals aged 5 through 64. Shipping of the updated formula begins immediately to ensure availability in pharmacies, hospitals, and clinics across the U.S. for the coming days. The approval is based on cumulative evidence showing the vaccine generates strong immune responses against currently circulating variants, including XFG and its sub-lineages.

•2mo ago

Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency

Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, their co-developed Lyme disease vaccine candidate. The application is supported by Phase 3 VALOR trial data showing more than 70% efficacy in preventing Lyme disease across 9,437 participants aged five and older. EMA validation confirms the application's completeness and initiates the formal review process, advancing the potential for the vaccine's commercialization in Europe.

•2mo ago

REG-Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency

Pfizer and partner Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, a Lyme disease vaccine candidate. The application is supported by data from the Phase 3 VALOR trial, which demonstrated an efficacy of more than 70% in participants aged five years and older. This validation initiates the EMA's assessment of the candidate, which aims to become the first approved vaccine for Lyme disease in Europe, a condition affecting over 100,000 people annually.

•2mo ago

Pfizer Reports Second-Quarter Results And Raises Midpoint of 2026 Revenue Guidance

Pfizer reported Q2 2026 revenue of $15.0 billion, representing 1% operational growth, and raised its full-year 2026 revenue guidance by $500 million at the midpoint to a range of $60.5 billion to $62.5 billion. Excluding COVID-19 products, revenue grew 5% operationally, while the company's core launched and acquired products portfolio delivered strong 18% operational growth driven by Eliquis, Padcev, and the Vyndaqel family. Adjusted diluted EPS was $0.77, flat with the prior year, while reported results reflected a non-cash intangible asset impairment charge of $4.3 billion resulting in a loss per share of $(0.04). The company announced an additional $2.5 billion in productivity enhancement savings expected from 2027 through 2029 and revealed that CFO Dave Denton will step down in August, with Cecile Guegan serving as interim successor.

•3mo ago

Pfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with Nonsegmental Vitiligo

Pfizer reported positive topline results from the TRANQUILLO Phase 3 program for LITFULO in nonsegmental vitiligo, with both pivotal studies meeting their co-primary endpoints for facial and total body repigmentation. The trials, which enrolled 2,174 patients across 271 sites, demonstrated significant improvement versus placebo at Week 52 with a safety profile consistent with the drug's established use in alopecia areata. Based on these results, Pfizer intends to submit global regulatory filings for LITFULO as a potential new oral systemic therapy for adults with nonsegmental vitiligo.

•3mo ago

European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union

The European Commission has granted marketing authorization for the Pfizer and BioNTech 2026-2027 COVID-19 vaccine formula targeting the XFG variant for individuals 6 months and older. The authorization covers all 27 EU Member States as well as Iceland, Liechtenstein, and Norway, following a recommendation from the EMA's Emergency Task Force. Manufacturing has been initiated at risk, with shipping expected to begin soon to ensure availability for the upcoming respiratory disease season.

•3mo ago

FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer

The FDA granted Priority Review to Pfizer's supplemental New Drug Application for TALZENNA combined with XTANDI for HRR gene-altered metastatic castration-sensitive prostate cancer (mCSPC), targeting a decision in the last quarter of 2026. The application is supported by Phase 3 TALAPRO-3 data demonstrating a 52% reduction in the risk of radiographic progression or death versus placebo plus XTANDI, with consistent benefits observed across both BRCA and non-BRCA patient groups. If approved, this label expansion would allow the combination to be used at an earlier stage of the disease, potentially delaying progression before the cancer becomes castration-resistant.

•3mo ago

U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

The FDA approved PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility. This approval establishes the first platinum-free regimen for this indication, supported by Phase 3 EV-304 data showing a 47% reduction in the risk of tumor recurrence, progression or death versus standard of care. Pfizer and Astellas highlighted that the combination demonstrated a 35% reduction in the risk of death and achieved a pathological complete response rate of 55.8%.

•3mo ago

Pfizer Declares Third-Quarter 2026 Dividend

Pfizer's board of directors declared a third-quarter 2026 cash dividend of $0.43 per share. The dividend is payable on September 1, 2026, to shareholders of record at the close of business on July 24, 2026. This upcoming payment marks Pfizer's 351st consecutive quarterly dividend, highlighting its commitment to maintaining shareholder returns.

•4mo ago

FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance

Pfizer announced FDA approval for IBRANCE in combination with anti-HER2 therapy for the maintenance treatment of HR+, HER2+ metastatic breast cancer. The approval is supported by Phase 3 PATINA trial data, which demonstrated a 24% reduction in the risk of disease progression or death compared to anti-HER2 and endocrine therapy alone. This label expansion makes IBRANCE the first and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status.

•4mo ago

U.S. FDA Approves Pfizer’s HYMPAVZI for the Treatment of Two Additional Hemophilia A or B Patient Populations with Significant Medical Need

The FDA approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B patients aged 12 and older with inhibitors, as well as pediatric patients aged 6 to 11 with or without inhibitors. This approval is supported by Phase 3 trial data showing a 93% reduction in annualized bleeding rates for inhibitor-positive patients compared to standard bypassing agents. HYMPAVZI is now the first subcutaneous non-factor therapy available for pediatric hemophilia B patients aged 6 to 11, expanding Pfizer’s footprint in a rare disease market with significant unmet medical need.

•5mo ago

Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA Berobenatide

Pfizer presented robust Phase 2b data for berobenatide, an investigational monthly GLP-1 receptor agonist, at the ADA Scientific Sessions. The VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9% with no plateau at 32 weeks, while VESPER-2 demonstrated a 2.2% reduction in HbA1c in patients with type 2 diabetes. Pfizer plans to advance 10 Phase 3 studies for berobenatide in 2026, targeting chronic weight management and comorbidities like knee osteoarthritis and obstructive sleep apnea.

•5mo ago

TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer

Pfizer announced positive pivotal Phase 3 results from the TALAPRO-3 study, showing TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% (HR 0.48) in men with HRR gene-mutated metastatic hormone-sensitive prostate cancer. At three years, radiographic progression-free survival was 77% for the combination versus 56% for placebo plus XTANDI, with median rPFS not reached in the treatment arm after over 37 months of follow-up. The benefit was consistent across BRCA and non-BRCA subgroups, and interim overall survival showed a strong trend (HR 0.77) though it did not reach statistical significance (p=0.09). Pfizer is discussing these results with global health authorities to potentially expand the existing indication.

•5mo ago

Seven-Year Analysis from Pfizer’s LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced Non-Small Cell Lung Cancer

Pfizer reported seven-year follow-up results from the Phase 3 CROWN trial for LORBRENA in ALK-positive advanced NSCLC. Patients treated with LORBRENA had a 55% likelihood of remaining alive without disease progression at seven years, compared to 3% for the XALKORI comparator arm. Median progression-free survival was not reached for LORBRENA, representing an 81% reduction in the risk of disease progression or death versus XALKORI. The data also showed a 94% reduction in the risk of intracranial progression, with no new brain metastasis events occurring after the first 30 months of treatment.

•5mo ago

Innovent Biologics and Pfizer Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

Pfizer and Innovent Biologics have entered a global strategic collaboration to develop 12 early-stage oncology programs, including antibody-drug conjugates and multi-specific antibodies. Innovent will receive a $650 million upfront payment and up to $9.85 billion in milestones, bringing the total deal value to $10.5 billion. Innovent retains Greater China rights for four co-developed programs. Pfizer will lead global development after Phase 1 for all programs, leveraging Innovent's discovery engine to accelerate its oncology pipeline with differentiated assets.

•5mo ago

Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

Pfizer entered a global strategic collaboration with Innovent Biologics to develop 12 early-stage oncology medicines, including antibody-drug conjugates and multi-specific antibodies. Innovent will receive a $650 million upfront payment and is eligible for up to $9.85 billion in milestone payments, plus double-digit royalties on approved products. The deal splits development responsibilities: Innovent leads through Phase 1, after which Pfizer takes over global development for most programs, with co-development and co-commercialization in the U.S. and Europe for four specific assets.

•5mo ago

European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors

The European Commission has approved Pfizer's HYMPAVZI for the treatment of adults and adolescents 12 years and older with hemophilia A or B with inhibitors. The approval is based on Phase 3 data from the BASIS trial, which demonstrated a 93% reduction in the mean treated annualized bleeding rate compared to on-demand therapy. HYMPAVZI is the only once-weekly subcutaneous treatment approved in the EU for both hemophilia A and B patients with inhibitors, offering a significant improvement in treatment options. Pfizer is also conducting further studies, including BASIS KIDS, to evaluate the safety and efficacy of HYMPAVZI in children under 18 years of age with hemophilia A or B with or without inhibitors.

•5mo ago

Arvinas and Pfizer Enter into a Transaction with Rigel Pharmaceuticals for the Exclusive Global Rights of VEPPANU (vepdegestrant)

Arvinas and Pfizer have entered into a license agreement with Rigel Pharmaceuticals for the exclusive global rights of VEPPANU (vepdegestrant), the first FDA-approved PROTAC. The deal includes an upfront payment of $85 million and the potential for up to $320 million in future milestone payments, as well as tiered royalties in the mid-teens to mid-20s. Rigel will be responsible for the commercialization of VEPPANU in the U.S. and will own global rights, with the ability to sublicense outside the U.S. Arvinas and Pfizer will continue to handle ongoing development activities and will receive a percentage of sublicensing revenue.

•5mo ago

Pfizer Reports Strong First-Quarter Results And Reaffirms 2026 Guidance

Pfizer reported first-quarter 2026 revenue of $14.5 billion, up 5% year-over-year (2% operationally), driven by a 22% operational surge in launched and acquired products like Padcev and Eliquis. The company reaffirmed full-year 2026 guidance for revenues of $59.5 billion to $62.5 billion and adjusted diluted EPS of $2.80 to $3.00, supported by $2.5 billion in R&D investment and positive Phase 3 readouts across its oncology and rare disease pipelines. Management returned $2.4 billion to shareholders via dividends while maintaining a $3.3 billion share repurchase authorization, though no buybacks are anticipated in 2026 as the company focuses on de-levering.

•6mo ago

Pfizer’s ELREXFIO Significantly Improves Progression-Free Survival for Double-Class Exposed Patients with Relapsed or Refractory Multiple Myeloma

Pfizer announced positive topline results from the Phase 3 MagnetisMM-5 study, where ELREXFIO monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus standard of care. The trial met its primary endpoint at the interim analysis with 497 patients enrolled across 26 countries, showing a safety profile consistent with previous experience. Management plans to discuss these data with global health authorities to support potential regulatory submissions for earlier lines of therapy.

•6mo ago

Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026

Pfizer will present over 40 abstracts at ASCO 2026, featuring late-breaking Phase 3 data for key assets like BRAFTOVI in colorectal cancer and TALZENNA plus XTANDI in prostate cancer. The data set includes a seven-year update for LORBRENA in lung cancer and early-stage results for next-generation pipeline candidates such as sigvotatug vedotin and PF-08634404. These presentations highlight the company's strategy to extend established therapies into earlier lines of treatment and advance novel mechanisms across solid tumors.

•6mo ago