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) invites investors and the public to join a webcast featuring CFO David Denton at the Wolfe Research Healthcare Conference on November 18, 2022, at 8:45 a.m. EST. Investors can access the webcast at www.pfizer.com/investors, where information on registration will also be available. A transcript and replay will be accessible on Pfizer's site within 24 hours post-event for at least 90 days. Pfizer focuses on innovative therapies, improving patients' lives, and enhancing healthcare access globally.
Pfizer and BioNTech announced robust results from a Phase 2/3 clinical trial for their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. A 30-µg booster significantly increased neutralizing antibody titers—13.2-fold in adults over 55 and 9.5-fold for those aged 18 to 55 compared to the original vaccine. The safety profile remains favorable, similar to the original vaccine. These findings suggest enhanced protection against Omicron variants and support ongoing evaluations of the vaccine's effectiveness against emerging strains.
Pfizer's investigational cancer immunotherapy, elranatamab, has received Breakthrough Therapy Designation from the FDA for treating relapsed or refractory multiple myeloma (RRMM). This designation is based on promising results from the Phase 2 MagnetisMM-3 study, which reported a 61% overall response rate after a median follow-up of 6.8 months. The therapy could provide significant advantages over existing treatments.
Elranatamab is designed to engage cancer and T-cells simultaneously, offering a novel approach to treatment.
Transgene (Euronext Paris: TNG) announces that an interim analysis of its Phase II clinical trial for TG4001 has shown promising results, leading the Independent Data Monitoring Committee to recommend continuation. The trial will now enroll 120 patients instead of the previously planned 150, with a completion expected in H1 2024. TG4001, a therapeutic vaccine for HPV16-positive anogenital tumors, is being tested in combination with avelumab, supplied by Pfizer (NYSE: PFE). A webcast on the interim results is scheduled for November 2, 2022.
Pfizer Inc. reported its third-quarter 2022 results, with revenues of $22.6 billion, a 6% decline compared to the previous year. Excluding contributions from Paxlovid and Comirnaty, the revenue showed a 2% operational growth. Reported diluted EPS increased by 6% to $1.51, and adjusted diluted EPS rose 40% to $1.78. The company raised its 2022 revenue guidance to $99.5-$102 billion and narrowed its adjusted diluted EPS guidance to $6.40-$6.50. Pfizer's pipeline includes promising candidates with positive Phase 3 data, and it plans to launch up to 19 new products within 18 months.
Pfizer announced positive Phase 3 trial results for its investigational RSV vaccine, RSVpreF, showing an efficacy of 81.8% against severe lower respiratory illness in infants up to 90 days old. The vaccine was well-tolerated with no safety issues noted in vaccinated individuals or their newborns. Pfizer plans to submit a Biologics License Application to the FDA by the end of 2022. If approved, this could be the first maternal vaccine to help prevent RSV in young infants, filling a critical public health need.
ViiV Healthcare has announced positive results from its phase IIa study of N6LS, a novel broadly neutralizing antibody, for treating HIV. The study demonstrated strong antiviral efficacy and tolerability at both high and low doses. Out of 14 participants, 13 showed a significant reduction in viral load. The results will be presented at the 30th HIV Glasgow Conference. ViiV plans to launch a phase IIb study in 2023 to further explore this treatment's potential.
The CARISEL study revealed that the long-acting regimen of cabotegravir and rilpivirine was successfully implemented across various European healthcare settings. Conducted by ViiV Healthcare, the study showed high acceptability, appropriateness, and feasibility among clinical staff and people living with HIV. At 12 months, 87% of participants maintained viral suppression while 81% felt the regimen was less stigmatizing than daily treatments. Staff identified and overcame initial implementation barriers, further endorsing this innovative treatment approach.
Pfizer Inc. (NYSE: PFE) is set to present diverse data from its infectious disease portfolio at IDWeek 2022, focusing on the efficacy and safety of its bivalent RSVpreF vaccine for older adults, alongside findings on PAXLOVID™ for COVID-19 treatment. A late-breaking presentation will detail results from the Phase 3 clinical trial of RSVpreF on October 20, 2022. The company aims to demonstrate its commitment to addressing critical health challenges posed by infectious diseases. Presentations will span a range of topics, showcasing investigational vaccines and therapies.
Pfizer and BioNTech have announced encouraging early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Following a 30-µg booster dose, participants exhibited a significant increase in neutralizing antibodies against the Omicron BA.4/BA.5 variants. Both younger and older adults demonstrated similar responses. Notably, the bivalent vaccine is expected to outperform the original vaccine in providing protection against these variants. The vaccine was well tolerated, with safety profiles resembling that of the original formulation. Additional data is forthcoming.