Pfizer Stock Price, News & Analysis

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.

ViiV Healthcare, majority owned by GSK and including Pfizer as a shareholder, has signed a new voluntary licensing agreement for cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to enhance access in low-income regions. This agreement allows selected generic manufacturers to produce cabotegravir LA for PrEP in 90 countries, following regulatory approval. With approximately 1.5 million new HIV cases annually, the long-acting injectable could significantly improve prevention efforts, particularly for women and adolescent girls.