Pfizer Stock Price, News & Analysis

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.

Pfizer Inc. (NYSE: PFE) announced FDA approval for an expanded indication of CIBINQO (abrocitinib) for adolescents aged 12 to <18 years with moderate-to-severe atopic dermatitis. Previously approved for adults only, this oral medication addresses uncontrolled symptoms in adolescents inadequately managed by other treatments. The JADE TEEN clinical trial demonstrated significant improvement in skin clearance and itch severity, with IGA 0 or 1 response rates of 39% and 46% for 100 mg and 200 mg doses, respectively. This new treatment offers a vital option for adolescents suffering from this debilitating skin condition.

Pfizer Inc. (NYSE: PFE) will host a webcast on February 16, 2023, at 10:00 a.m. EST, featuring Andy Schmeltz and Navin Katyal discussing the company's mRNA portfolio at the SVB Securities Global Biopharma Conference. Interested parties can access the live discussion via Pfizer's investor website, www.pfizer.com/investors. A transcript and replay of the webcast will be available within 24 hours, accessible for at least 90 days. Pfizer focuses on innovative therapies and vaccines to enhance patient lives globally, highlighting its commitment to health care access.

Pfizer reported record revenues of $100.3 billion for full-year 2022, up 23% year-over-year, driven by operational growth of 30%. Fourth-quarter revenues reached $24.3 billion, marking 2% growth. Reported diluted EPS for 2022 was $5.47, up 42%, while adjusted diluted EPS rose 62% to $6.58. For 2023, Pfizer anticipates revenues of $67.0 to $71.0 billion, primarily due to a decline in COVID-19 product sales. However, excluding these products, operational growth of 7% to 9% is expected. The company aims to invest significantly in launches and R&D to drive long-term growth, including anticipated launches of new products.