Pfizer Stock Price, News & Analysis

Pfizer (NYSE: PFE) has announced FDA approval for ZAVZPRET (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for acute migraine treatment in adults. In pivotal Phase 3 studies, ZAVZPRET proved statistically superior to placebo in achieving pain freedom and alleviating bothersome symptoms at two hours post-dose. ZAVZPRET offers a rapid onset of action, with relief as early as 15 minutes. Targeted for July 2023 availability, this new treatment expands Pfizer's migraine portfolio, catering to the significant population of nearly 40 million migraine sufferers in the U.S.

Pfizer (NYSE: PFE) announced that the FDA’s Vaccines Advisory Committee voted 7-4 on both safety and effectiveness of its RSV vaccine candidate, PF-06928316 (RSVpreF). This decision supports the prevention of respiratory syncytial virus (RSV) in adults aged 60 and older. The recommendation is based on strong Phase 3 clinical trial evidence. The FDA's final decision is expected by May 2023. RSV poses a significant health threat, causing 60,000-160,000 hospitalizations and 6,000-13,000 deaths annually in older adults in the U.S., highlighting the need for effective vaccine options.

Pfizer Inc. (NYSE: PFE) will host a webcast discussion on March 7, 2023, at 10:30 a.m. EST, during the Cowen 43rd Annual Health Care Conference. Key speakers include Angela Hwang, Rodrigo Puga, and Annaliesa Anderson. Investors and the public can access the live webcast and registration details at www.pfizer.com/investors. A transcript and replay will be available within 24 hours after the event and will remain accessible for 90 days. Pfizer aims to leverage its science and resources to enhance patient life quality, focusing on innovative medicines and vaccines.

ViiV Healthcare, majority owned by GSK with Pfizer as a shareholder, has reported positive results from the SOLAR study. This Phase IIIb trial evaluates the long-acting injectable regimen Cabenuva (cabotegravir, rilpivirine) against the daily oral regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Findings indicate CAB+RPV LA maintains non-inferior efficacy compared to BIC/FTC/TAF over 12 months, with 90% of participants preferring the long-acting treatment. The study included 670 participants; CAB+RPV LA demonstrated 90% virologic suppression, and treatment satisfaction significantly improved. Results were shared at the 30th CROI.

Pfizer Inc. (NYSE:PFE) announced that the FDA has granted Priority Review for its Biologics License Application for elranatamab, a bispecific antibody targeting B-cell maturation antigen for treating relapsed or refractory multiple myeloma (RRMM). This review is anticipated to expedite the availability of the drug, which aims to improve patient outcomes significantly. The FDA is expected to make a decision in 2023. The European Medicines Agency has also accepted the marketing application for elranatamab, which shows promising results, including a 61% response rate in patients after a 10.4-month follow-up in clinical trials.

Pfizer announced that the FDA has accepted its Biologics License Application for the RSV vaccine candidate RSVpreF, aimed at preventing respiratory illness in infants through maternal immunization. The decision comes after the vaccine received Breakthrough Therapy Designation in March 2022. If approved, RSVpreF would be the first vaccine to protect infants from RSV, which causes significant hospitalizations and deaths annually. The FDA has set an action date of August 2023 for this review. Additionally, the EMA is reviewing the MAA for the vaccine under accelerated assessment for both maternal immunization and older adults.

Pfizer (NYSE: PFE) reports promising results from the Phase 3 TALAPRO-2 study, showing a 37% reduction in disease progression or death risk in men with metastatic castration-resistant prostate cancer (mCRPC) treated with TALZENNA and XTANDI. The FDA has granted Priority Review for the supplemental drug application for this combination. The study demonstrated a statistically significant improvement in radiographic progression-free survival (rPFS). Final overall survival data is pending. Safety profiles for TALZENNA plus XTANDI were consistent with known risks, with frequent adverse events including anemia and decreased platelet counts.

Pfizer Inc. (NYSE: PFE) announced the publication of positive Phase 3 trial results for zavegepant, an intranasal formulation of a CGRP receptor antagonist for acute migraine treatment. The trial involved 1,405 participants and demonstrated zavegepant's superiority over placebo in achieving pain freedom (24% vs 15%) and relief from the most bothersome symptom (40% vs 31%) at two hours post-dose. Relief began as early as 15 minutes and lasted up to 48 hours for many patients. Zavegepant was generally well tolerated, with no serious adverse events reported. The NDA for zavegepant has been submitted to the FDA, with a decision expected in 1Q2023.

ViiV Healthcare, majority-owned by GSK, presented key findings on innovative HIV treatment and prevention options at CROI 2023 in Seattle, held from February 19-22, 2023. Notably, the first head-to-head study comparing Cabenuva's long-acting regimen against the daily oral Biktarvy was showcased. New data on cabotegravir for HIV prevention, particularly among underrepresented communities, was also revealed. Kimberly Smith, M.D., emphasized the importance of long-acting treatments in improving patient satisfaction. Other studies highlighted included findings from SOLAR and HPTN trials focusing on the efficacy and safety of novel treatment options.