Pfizer Inc. (NYSE: PFE) 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. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information...
Pfizer Inc. (NYSE: PFE) 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 LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection...
Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ELREXFIO™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for...
Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2023. The company narrowed its 2023 revenue guidance (4) range to $67 to $70 billion, while maintaining its outlook for Adjusted diluted EPS (3) of $3.25 to $3.45. The second-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com . EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and Chief Executive...
Pfizer Inc. (NYSE: PFE) today announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology. Effective today, Chris Boshoff, M.D., PhD, will join Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Under his leadership, Pfizer will continue to invest in its fight...
Pfizer Inc. (NYSE: PFE) today announced the company’s immediate efforts to provide relief and repair the damage caused to its manufacturing facility in Rocky Mount, North Carolina after a violent tornado swept through the town on Wednesday, July 19. All 3,200 local Pfizer colleagues reporting to this manufacturing site are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan. Crews are working around-the-clock to restore power, assess the...
Pfizer Inc. (NYSE: PFE) today announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease. In stage two of the three-part study, which enrolled 360 healthy pregnant individuals, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies...
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. NGENLA is expected to become available for U.S. prescribing in August 2023. Growth hormone deficiency (GHD) is a rare disease characterized...
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application (MAA) for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency (EMA). Fidanacogene elaparvovec is a novel, investigational gene therapy that contains a...
Pfizer Inc. (NYSE: PFE) today announced its decision to continue to progress one oral late-stage glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidate toward further clinical development for the potential treatment of adults with obesity and Type 2 diabetes mellitus (T2DM). Moving forward, the company will continue advancing the clinical program for danuglipron (PF-06882961), subject to results from the ongoing Phase 2 trial, and discontinue the clinical development of lotiglipron...
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata. “While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs...
Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 third-quarter 2023 dividend on the company’s common stock, payable September 5, 2023, to holders of the Common Stock of record at the close of business on July 28, 2023. The third-quarter 2023 cash dividend will be the 339th consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people...
Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval is based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data...
Pfizer Inc. (NYSE: PFE) 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 Tuesday, August 1, 2023. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2023 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors . Information on accessing and...
Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a discussion with William Pao, Chief Development Officer, Executive Vice President, at the Goldman Sachs 44 th Annual Global Healthcare Conference on Tuesday, June 13, 2023 at 8:00 a.m. Pacific Daylight Time. To view and listen to the webcast, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors...
Pfizer Inc . (NYSE: PFE) today announced positive results from the Phase 3 program comprising the REVISIT ( NCT03329092 ) and ASSEMBLE ( NCT03580044 ) studies evaluating the efficacy, safety, and tolerability of the novel investigational antibiotic combination aztreonam-avibactam (ATM-AVI) in treating serious bacterial infections due to Gram-negative bacteria, including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data...
Pfizer Inc. (NYSE: PFE) 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 caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective. “A vaccine to help...
Pfizer Inc. (NYSE: PFE) today announced that the pivotal Phase 3 BASIS clinical trial ( NCT03938792 ) evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects. Marstacimab, a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people without inhibitors to Factor VIII (FVIII) or Factor IX (FIX), was administered weekly with flat (not weight-based)...
Pfizer Inc. (NYSE: PFE) will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6. Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. In addition, Pfizer will highlight its ongoing...
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain...
