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 (NYSE:PFE) announced positive interim results from its Phase 3 RENOIR trial for the bivalent RSV vaccine candidate, RSVpreF. The vaccine showed an efficacy of 85.7% against severe lower respiratory tract illness (LRTI-RSV) in adults aged 60 and older. The findings were considered significant enough for Pfizer to plan a Biologics License Application (BLA) submission to the FDA in fall 2022. The vaccine was reported to be well-tolerated, with no safety concerns noted during the trial.
Pfizer and BioNTech have updated the efficacy results of their COVID-19 vaccine for children aged 6 months to 4 years, reporting a vaccine efficacy of 73.2% based on 34 cases observed more than seven days post-vaccination. Efficacy was confirmed across variants, primarily Omicron BA.2, with favorable safety profiles. The data supports the ongoing review for Emergency Use Authorization by the FDA and a conditional Marketing Authorization by the EMA, alongside plans for an adapted vaccine targeting emerging Omicron strains.
Pfizer and BioNTech announced their submission to the FDA for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals aged 12 and older. The companies have rapidly scaled production and are prepared to begin shipping doses immediately upon authorization. A similar application has been submitted to the European Medicines Agency. The bivalent vaccine is designed to generate a robust immune response against multiple variants, with pre-clinical data showing strong neutralizing antibody responses against Omicron variants and the original strain.
Pfizer Inc. (NYSE: PFE) will host a webcast featuring Mikael Dolsten, Chief Scientific Officer, at the Handelsbanken Life Science Innovation Day on August 24, 2022, at 4:30 p.m. CEST (10:30 a.m. EDT). Interested parties can access the live discussion or register via Pfizer's investor website. Following the event, a transcript and replay will be available within 24 hours for 90 days. Pfizer emphasizes its commitment to improving global health through innovative therapies and vaccines.
Pfizer announced positive top-line results from its pivotal Phase 3 study of the 20-valent pneumococcal conjugate vaccine candidate (20vPnC) aimed at preventing invasive pneumococcal disease in infants. The vaccine candidate achieved statistical non-inferiority for all 20 serotypes after the fourth dose. It also demonstrated a favorable safety profile similar to Prevnar 13. Pfizer intends to submit a supplemental Biologics License Application by year-end 2022, pending discussions with the U.S. FDA, to potentially address the significant burden of infant pneumococcal disease.
NextRNA Therapeutics announces the appointment of Dominique Verhelle, PhD, MBA, as CEO, effective immediately. Verhelle, a co-founder of the company, has spearheaded its scientific and corporate strategy since its inception. Under her leadership, NextRNA secured $56M in financing to advance its unique platform aimed at developing small molecule drugs targeting non-coding RNA interactions. Additionally, Jason Katz has been appointed as VP and Head of Drug Discovery, bringing extensive drug discovery experience from IFM Therapeutics and Merck.
Pfizer (PFE) and Valneva (VALN) have initiated a Phase 3 clinical study named VALOR to evaluate their investigational Lyme disease vaccine, VLA15, among 6,000 participants in Lyme-endemic areas in Europe and the U.S. This randomized, placebo-controlled trial aims to investigate the vaccine's efficacy, safety, and immunogenicity. VLA15 is the only Lyme vaccine candidate currently in clinical development, and prior studies have shown promising immunogenicity and tolerability. Pfizer plans to submit regulatory applications by 2025, upon successful trial completion.
Pfizer announced the acquisition of Global Blood Therapeutics (GBT) for $68.50 per share in cash, totaling approximately $5.4 billion. This acquisition aims to enhance Pfizer's portfolio in sickle cell disease (SCD), addressing critical needs in this underserved community. GBT's Oxbryta, a first-in-class SCD treatment, generated $195 million in net sales in 2021. The combined franchise from both companies could exceed $3 billion in peak sales worldwide. The deal awaits stockholder and regulatory approvals.
ViiV Healthcare announced week 240 results from the phase III BRIGHTE study of fostemsavir, demonstrating significant virologic responses in heavily treatment-experienced adults with multidrug-resistant HIV-1. The study involved 371 patients and found that 45% achieved virologic suppression. CD4+ cell counts increased by 296 cells/mm³, with 78% reaching counts of ≥200 cells/mm³. Safety profiles remained consistent, with 95% experiencing adverse events, primarily nausea and diarrhea. Fostemsavir serves as a crucial treatment option for patients facing limited alternatives due to resistance or safety issues.
ViiV Healthcare announced new findings from the HPTN 084 trial at the 24th International AIDS Conference, showing that cabotegravir long-acting (LA) for pre-exposure prophylaxis (PrEP) demonstrated an 89% lower rate of new HIV infections compared to daily oral tablets. No new HIV cases were reported among participants receiving cabotegravir during the unblinded period. Additionally, no birth defects were recorded among women who became pregnant post-injection. Cabotegravir LA is currently approved in the U.S. as Apretude.