Welcome to our dedicated page for Pfizer news (Ticker: PFE), a resource for investors and traders seeking the latest updates and insights on Pfizer stock.
Pfizer Inc. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
Pfizer Inc. (NYSE:PFE) announced the acceptance of its 20-valent pneumococcal conjugate vaccine (20vPnC) by the FDA for priority review. This vaccine aims to prevent invasive pneumococcal disease in infants and children aged 6 weeks to 17 years. The FDA's priority review expedites the evaluation process by four months, with a decision expected by April 2023. The vaccine includes 20 serotypes, potentially offering the broadest coverage among pneumococcal vaccines. Results from Phase 3 trials, involving over 4,300 participants, support this submission.
Pfizer Inc. (NYSE: PFE) will host a webcast featuring CEO Albert Bourla at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 3:00 p.m. PST. Investors and the public can access the live discussion via www.pfizer.com/investors. A transcript and replay will be available within 24 hours and accessible for at least 90 days. Pfizer is committed to advancing global health through innovative therapies and vaccines, enhancing the quality and safety of healthcare for patients worldwide.
Pfizer (NYSE: PFE) reported positive top-line results from the Phase 3 BENEGENE-2 study of fidanacogene elaparvovec, a gene therapy for severe hemophilia B. The study demonstrated a 71% reduction in annualized bleeding rate (ABR) compared to standard prophylaxis with Factor IX. Secondary endpoints also showed significant improvements in treated ABR and infusion rates. Fidanacogene elaparvovec was well-tolerated, with a safety profile consistent with earlier studies. Pfizer is advancing multiple gene therapy programs and plans to discuss these results with regulatory authorities in early 2023.
Pfizer Inc. (PFE) announced that the FDA accepted for review its Biologics License Application for the investigational pentavalent meningococcal vaccine candidate, MenABCWY. This vaccine targets the most common serogroups causing meningococcal disease in individuals aged 10-25. If approved by October 2023, it could streamline the vaccination schedule and enhance coverage. A Phase 3 trial indicated that the vaccine was well-tolerated, and it could potentially reduce invasive meningococcal disease cases in the U.S., addressing low vaccination rates among adolescents.
Pfizer Inc. (NYSE: PFE) announced that the FDA has accepted for review a New Drug Application for etrasimod, targeting moderately-to-severely active ulcerative colitis (UC). This follows positive results from two Phase 3 trials (ELEVATE UC 52 and UC 12) demonstrating significant clinical remission compared to placebo. The FDA decision is expected in the second half of 2023, with EMA review anticipated in early 2024. Etrasimod, an oral S1P receptor modulator, aims to provide a new therapeutic option for the 3.8 million people affected by UC.
Pfizer Inc. (NYSE: PFE) will host a conference call for investment analysts at 10 a.m. EST on January 31, 2023, to discuss its Fourth Quarter and Full Year 2022 Performance Report. Investors and the public can access the webcast and Performance Report through Pfizer's investor relations website. Participants must register in advance. The call can be listened to by dialing 800-456-4352 (U.S.) or 785-424-1086 (international) with the passcode '51512'. A transcript and replay will be available for 90 days.
Kindeva Drug Delivery and Meridian Medical Technologies have successfully merged, forming a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. The newly combined entity, Kindeva, will leverage enhanced capabilities across various drug delivery methods, including inhalation and transdermal solutions. Milton Boyer, former CEO of Meridian, now leads Kindeva. This merger consolidates Kindeva's existing strength as a leader in drug-device solutions, having a rich history of innovation since the 1950s.
Pfizer (NYSE:PFE) presented positive results from the Phase 2 MagnetisMM-3 trial of elranatamab at the 2022 ASH Annual Meeting. The study reported a high objective response rate of 61% in patients with relapsed/refractory multiple myeloma (RRMM), with an 84% probability of maintaining this response at nine months. Elranatamab demonstrated early and deep responses, alongside manageable safety, indicating its potential as a transformative treatment in a high-need area. The trial involved 123 heavily pretreated patients, showing promising signs for further studies.
Pfizer Inc. (NYSE: PFE) announced an increase in its quarterly cash dividend to $0.41 per share for the first quarter of 2023. This dividend, which is the 337th consecutive quarterly dividend, will be payable on March 3, 2023, to shareholders on record as of January 27, 2023. Pfizer's CEO Albert Bourla emphasized that this increase reflects the company’s robust financial performance in 2022 and highlights its commitment to returning value to shareholders.
Pfizer and BioNTech announce the FDA's Emergency Use Authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a third 3-µg dose in the primary vaccination series for children aged 6 months to 4 years. Given the urgent need due to rising COVID-19 cases and respiratory illnesses in young children, vaccine doses will ship immediately upon CDC recommendation. The EUA is supported by clinical data and aims to enhance protection against severe illness in this age group.