Articles from Pfizer Inc.

Pfizer Inc. (NYSEPFE) will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates.

Pfizer Inc. (NYSEPFE) today announced positive results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. At the time of this analysis, the BRAFTOVI combination regimen demonstrated a clinically meaningful and statistically significant improvement in confirmed objective response rate (ORR) assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab (60.9% vs 40.0%, odds ratio =2.443, p=0.0008). These results will be presented today in an oral presentation (Abstract 16) at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine.

Pfizer Inc. (NYSEPFE) today announced positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance).

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 9:45 a.m. PST.

Pfizer Inc. (NYSEPFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval is among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:30 a.m. EST on Tuesday, February 4, 2025. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter and Full Year 2024 Performance Report, to be issued that morning.

Pfizer Inc. (NYSEPFE) today provided its full-year 2025 guidance(1) and reaffirmed its October 29, 2024 full-year 2024 guidance(1). The accompanying presentation can be found at www.pfizer.com/investors.

Pfizer Inc. (NYSEPFE) and Alliance Foundation Trials, LLC (AFT) today announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). In the study, which is sponsored by AFT, median PFS was 44.3 months (95% CI: 32.4-60.9) for patients treated with IBRANCE in combination with anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy, and 29.1 months (95% CI: 23.3-38.6) for patients treated with anti-HER2 therapy and endocrine therapy alone [HR: 0.74 (95% CI, 0.58-0.94); unstratified 1-sided p= 0.0074]. This represents an extension in median PFS of over 15 months. Overall survival, a secondary endpoint, was not yet mature at the time of the analysis. These results are being presented during a late-breaking oral session (Abstract GS2-12) and highlighted in the press program at the 47th San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 8:30 a.m. EST on Tuesday, December 17, 2024. The purpose of the call is to provide Pfizer’s full-year 2025 financial guidance.

Pfizer Inc. (NYSEPFE) will highlight the latest advancements from its growing hematology and breast cancer portfolios at the American Society of Hematology (ASH) Annual Meeting & Exposition (December 7-10) and the San Antonio Breast Cancer Symposium (SABCS, December 10-13). Data from more than 100 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 13 oral presentations and four poster spotlights, will be shared across the company’s approved medicines and expanding portfolio of potential breakthroughs for patients with blood and breast cancers, as well as rare blood disorders.

Pfizer Inc. (NYSEPFE) today announced that after a comprehensive internal and external selection process, the company is appointing Chris Boshoff, M.D., PhD, as Chief Scientific Officer and President, Research & Development effective January 1, 2025. Dr. Boshoff, who most recently served as Chief Oncology Officer and Executive Vice President, will succeed Dr. Mikael Dolsten whose departure from Pfizer was announced earlier this year. In his new role, Dr. Boshoff will remain a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla, and he will oversee all functions of Research & Development across all therapeutic areas.

Pfizer Inc. (NYSEPFE) announced today that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a discussion with Andrew Baum, Chief Strategy and Innovation Officer, Executive Vice President, and Dave Denton, Chief Financial Officer, Executive Vice President, at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024 at 9:00 a.m. GMT.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a discussion with Aamir Malik, Chief U.S. Commercial Officer, Executive Vice President, at the UBS Global Healthcare Conference on Wednesday, November 13, 2024 at 12:30 p.m. PST.

Pfizer Inc. (NYSEPFE) reported financial results for the third quarter of 2024 and raised its full-year 2024 guidance(1) for both Revenues and Adjusted(2) diluted EPS.

Pfizer Inc. (NYSEPFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. With respect to PREVNAR 20, ACIP recommended:

Pfizer Inc. (NYSEPFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.

Pfizer Inc. (NYSEPFE) today announced the election of Mortimer (“Tim”) J. Buckley to its Board of Directors, effective immediately, following a lengthy and comprehensive search that began in May 2024. Mr. Buckley, age 55, was also appointed to and will join the Governance and Sustainability Committee and the Audit Committee of Pfizer’s Board. Following the appointment of Mr. Buckley, the Board will comprise 14 directors, 13 of whom are independent.

Pfizer Inc. (NYSEPFE) announced today that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors.

Pfizer Inc. (NYSEPFE) today announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in patients with metastatic castration-resistant prostate cancer (mCRPC). Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone.

Pfizer Inc. (NYSEPFE) today announced that its board of directors declared a $0.42 fourth-quarter 2024 dividend on the company’s common stock, payable December 2, 2024, to holders of the Common Stock of record at the close of business on November 8, 2024. The fourth-quarter 2024 cash dividend will be the 344th consecutive quarterly dividend paid by Pfizer.

Pfizer Inc. (NYSEPFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases.

Pfizer Inc. (NYSEPFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY® KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, Pfizer and BioNTech���s Omicron KP.2-adapted COVID-19 vaccine will ship to European Union (EU) member states that have specifically ordered this formulation.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EDT on Tuesday, October 29, 2024. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2024 Performance Report, to be issued that morning.

Pfizer Inc. (NYSEPFE) today announced its Phase 2 study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15. Cachexia is a common, life-threatening wasting condition that can significantly impact quality of life in affected patients with cancer.ii,iii Results will be presented today as a late-breaking Proffered Paper Presentation (LBA82) at the European Society for Medical Oncology (ESMO) 2024 Congress and have simultaneously been published in The New England Journal of Medicine (NEJM).

Pfizer Inc. (NYSEPFE) today announced longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). After an additional 18 months of follow-up, the objective response rate (ORR) and the median duration of response (DoR) as assessed by independent radiology review were 75% and 40 months in treatment-naïve patients and 46% and 16.7 months in previously treated patients, respectively. In addition, after approximately three years of follow-up in treatment-naïve patients, the median progression-free survival (PFS) with BRAFTOVI + MEKTOVI was 30.2 months (95% confidence interval [CI], 15.7-not estimable [NE]), while median overall survival (OS) was not yet reached (95% CI, 31.3-NE). These data will be presented today during a late-breaking oral session (Abstract LBA56) at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

Pfizer Inc. (NYSEPFE) continues to showcase potential practice-changing research and next-generation candidates across its robust Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17 in Barcelona. Data from more than 50 company-sponsored, investigator-sponsored and collaborative research abstracts, including more than 10 oral and mini-oral presentations, will be presented across the company’s tumor areas and core scientific modalities, as well as a potential treatment for a cancer-related condition.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a discussion with David Denton, Chief Financial Officer, Executive Vice President, at the Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, 2024 at 8:30 a.m. EDT.

Pfizer Inc. (NYSEPFE) today introduced PfizerForAll, a user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S. The new, end-to-end experience will support the millions of Americans affected annually by common illnesses like migraine, COVID-19 or flu, and those seeking to protect themselves with adult vaccinations. By bringing together critical resources and services into a single destination, PfizerForAll helps individuals and their families cut down on the time and steps needed to take important health actions like getting care, filling prescriptions, and finding potential savings on Pfizer medicines.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met. In a separate Phase 2 trial, Pfizer evaluated trivalent (“tIRV”) influenza mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age. The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

Pfizer Inc. (NYSEPFE) today announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

Pfizer Inc. (NYSEPFE) reported financial results for the second quarter of 2024 and raised its full-year 2024 guidance(1) for both Revenues and Adjusted(2) diluted EPS.

Pfizer Inc. (NYSEPFE) today announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX® (fidanacogene elaparvovec), a gene therapy for the treatment of severe and moderately severe hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. DURVEQTIX is designed to enable people living with hemophilia B to produce factor IX (FIX) themselves via a one-time dose, rather than multiple intravenous FIX infusions weekly or biweekly with the current standard of care.1,2,3

Pfizer Inc. (NYSEPFE) today announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A.

Pfizer Inc. (NYSEPFE) today announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.

Pfizer Inc. (NYSEPFE) today announced that the company is launching the process to identify a successor for Dr. Mikael Dolsten, Pfizer’s Chief Scientific Officer and President, Pfizer Research & Development, who will depart the company after a more than 15-year stellar career. This process is expected to last several months, probably through early next year. Pfizer will initiate an external search for a new Chief Scientific Officer, and Dr. Dolsten will assist in this search and continue to serve in his current position until his successor is in place and any necessary transition is complete.

Pfizer Inc. (NYSEPFE) today announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately. Mr. Taraporevala, age 57, was also appointed to and will join the Audit Committee and Compensation Committee of Pfizer’s Board.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that “evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”1,2

Pfizer Inc. (NYSEPFE) today announced that its board of directors declared a $0.42 third-quarter 2024 dividend on the company’s common stock, payable September 3, 2024, to holders of the Common Stock of record at the close of business on July 26, 2024. The third-quarter 2024 cash dividend will be the 343rd consecutive quarterly dividend paid by Pfizer.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:30 a.m. EDT on Tuesday, July 30, 2024. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2024 Performance Report, to be issued that morning.

Pfizer Inc. (NYSEPFE) today announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). The study demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial.

Pfizer Inc. (NYSEPFE) today announced that CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. The primary endpoint in the final analysis was assessed by change in the North Star Ambulatory Assessment (NSAA) at one year after treatment. Key secondary endpoints, including 10-meter run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo.

Pfizer Inc. (NYSEPFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 11:20 a.m. Eastern Daylight Time.

Pfizer Inc. (NYSEPFE) today announced detailed overall survival (OS) results from the Phase 3 ECHELON-3 study of ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study showed that the ADCETRIS combination reduced patients’ risk of death by 37% compared to placebo in combination with lenalidomide and rituximab (HR 0.63 [95% CI: 0.445-0.891] p=0.0085). The overall survival benefit was consistent across levels of CD30 expression.

Pfizer Inc. (NYSEPFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). After five years of median follow-up, median progression-free survival (PFS) based on investigator assessment was not reached with LORBRENA, with an observed Hazard Ratio (HR) of 0.19 (95% Confidence Interval [CI], 0.13-0.27), representing an 81% reduction in the rate of disease progression or death compared to XALKORI. Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm. These data will be presented today in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8503) and have been simultaneously published in the Journal of Clinical Oncology.

Pfizer Inc. (NYSEPFE) today announced that Andrew Baum, M.D., will join the company as Chief Strategy and Innovation Officer, Executive Vice President. Dr. Baum will be a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla. He joins Pfizer from Citi, where he served as Head of Global Healthcare, Managing Director Equity Research. Prior to joining Citi in 2011, Dr. Baum covered European Pharmaceuticals at Morgan Stanley for 14 years and earlier in his career was a practicing physician at the Royal National Orthopaedic Radcliffe Hospital in Oxford where he completed his residency.

Pfizer Inc. (NYSEPFE) reported financial results for the first quarter of 2024 and raised its Adjusted(3) diluted EPS guidance while maintaining all other components of its 2024 financial guidance(6).

Pfizer Inc. (NYSEPFE) and Genmab A/S (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Pfizer Inc. (NYSEPFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago. More than 50 abstracts, including 11 oral presentations, will be presented from Pfizer’s broadened portfolio of approved and pipeline therapies across the company’s key tumor areas and core scientific modalities, including small molecules, antibody-drug conjugates (ADCs) and bispecific antibodies.

Pfizer Inc. (NYSEPFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.1,2

Pfizer Inc. (NYSEPFE) today announced that its board of directors declared a $0.42 second-quarter 2024 dividend on the company’s common stock, payable June 14, 2024, to holders of the Common Stock of record at the close of business on May 10, 2024. The second-quarter 2024 cash dividend will be the 342nd consecutive quarterly dividend paid by Pfizer.

Pfizer Inc. (NYSEPFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

Pfizer Inc. (NYSEPFE) announced today that its shareholders and the general public are invited to access its virtual-only 2024 Annual Meeting of Shareholders at 9:00 a.m. EDT on Thursday, April 25, 2024. Pfizer has designed the virtual Annual Meeting to ensure that its shareholders who attend the virtual-only Annual Meeting will be afforded comparable rights and opportunities to participate as they would at an in-person meeting.

Pfizer Inc. (NYSEPFE) today announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Wednesday, May 1, 2024. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2024 Performance Report, to be issued that morning.

Pfizer Inc. (NYSEPFE) today announced that the European Commission (EC) has granted marketing authorization for the company’s 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

Pfizer Inc. (NYSEPFE) today announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Pfizer Inc. (NYSEPFE) invites investors and the general public listen to a webcast of a discussion with Mikael Dolsten, Chief Scientific Officer & President, Pfizer Research and Development, at the Leerink Partners Global Biopharma Conference 2024 on Tuesday, March 12, 2024 at 8:00 a.m. Eastern Daylight Time.

At a meeting with the investment community today, Pfizer Inc. (NYSEPFE) outlined its strategic priorities for the newly formed Oncology organization — and how its deep and diverse pipeline, industry-leading Oncology expertise, and anticipated near- and mid-term catalysts are expected to position the company to deliver strong growth and shareholder value. A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors.

Pfizer Inc. (NYSEPFE) today announced top-line ABRYSVO® vaccine efficacy and safety data for respiratory syncytial virus (RSV) in adults 60 years of age and older following a second season in the Northern and Southern Hemispheres from the ongoing pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). Vaccine efficacy against RSV-associated lower respiratory tract disease (LRTD), defined by three or more symptoms, after disease surveillance in season two was 77.8% (95.0% CI: 51.4, 91.1); vaccine efficacy following season one was 88.9% (95.0% CI: 53.6%, 98.7%)1, which demonstrates durable efficacy after two seasons.

Pfizer Inc. (NYSEPFE) invites investors and the general public to listen to a webcast of a discussion with David Denton, Chief Financial Officer, Executive Vice President, at the TD Cowen 44th Annual Health Care Conference on Monday, March 4, 2024 at 11:10 a.m. Eastern Standard Time.

Pfizer Inc. (NYSEPFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Pfizer Inc. (NYSEPFE) invites investors and the general public to access a live video webcast of its Oncology Innovation Day on Thursday, February 29, 2024, from 1:00 p.m. EST to 5:30 p.m. EST, with an approximately 20-minute break at the midpoint. During the event, Pfizer Oncology leadership will provide details on the new combined Pfizer Oncology Division, including its strategic approach, robust portfolio, industry-leading R&D capabilities and potential for growth through 2030 and beyond.

The American Cancer Society (ACS) and Pfizer Inc. (NYE: PFE) today announced the launch of “Change the Odds™: Uniting to Improve Cancer Outcomes,” a three-year initiative to bridge the gap in cancer care disparities. Through $15 million in funding from Pfizer, the initiative aims to improve health outcomes in medically underrepresented communities across the United States by enhancing awareness of and access to cancer screenings, clinical trial opportunities, and patient support and comprehensive navigation. “Change the Odds” will initially focus on breast and prostate cancer in medically underserved communities, with the potential to expand to additional cancer types. ACS plans to engage additional partners to extend the reach of the programmatic activities to more individuals and deepen the tangible impact in select communities.

Pfizer Inc. (NYSEPFE) reported financial results for fourth quarter and full-year 2023 and reaffirmed its 2024 financial guidance(5) provided on December 13, 2023.

Pfizer Inc. (NYSEPFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, PADCEV with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Pfizer Inc. (NYSEPFE) today announced that it has received notice of an unsolicited mini-tender offer by TRC Capital Investment Corporation of Ontario, Canada to purchase up to 4 million shares of Pfizer common stock at a price of $27.35 per share in cash. TRC Capital Investment’s offer price of $27.35 per share is approximately 4.4 percent lower than the $28.61 closing share price of Pfizer’s common stock on December 27, 2023 – the business day prior to the date of the offer. The offer is for approximately 0.071 percent of the shares of Pfizer common stock outstanding as of the December 28, 2023 offer date.

Pfizer Inc. (NYSEPFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

Pfizer Inc. (NYSEPFE) today announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations.

Pfizer Inc. (NYSEPFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 3:00 p.m. PST.

Pfizer Inc. (NYSEPFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EST on Tuesday, January 30, 2024. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Fourth Quarter and Full Year 2023 Performance Report, to be issued that morning.

Pfizer Inc. (NYSEPFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Pfizer Inc. (NYSEPFE) today announced that its board of directors declared an increase in the quarterly cash dividend on the company’s common stock to $0.42 for the first-quarter 2024 dividend, payable March 1, 2024, to holders of the Common Stock of record at the close of business on January 26, 2024. The first-quarter 2024 cash dividend will be the 341st consecutive quarterly dividend paid by Pfizer.