Pfizer Inc. - PFE STOCK NEWS

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.

Everest Medicines announced positive top-line results from a Phase I clinical trial of EVER206 in healthy subjects in China. The study demonstrated that EVER206, a novel treatment for multi-drug resistant (MDR) gram-negative bacterial infections, was well-tolerated with no new safety signals. The safety profile was consistent with previous studies. The trial involved 72 subjects across various dosage cohorts, and most adverse events were mild. The results support Everest's plans to advance EVER206 to late-stage clinical development. Everest holds exclusive rights for EVER206 in Greater China, South Korea, and certain Southeast Asian countries.

Pfizer (NYSE: PFE) has expanded its commitment to An Accord for a Healthier World, offering a full portfolio of medicines and vaccines on a not-for-profit basis to 1.2 billion people across 45 lower-income countries. This initiative now includes approximately 500 products, increasing from the initial 23 patented medicines and vaccines available in the U.S. and EU. The Accord aims to address health inequities and includes both patented and off-patent treatments for infectious and non-communicable diseases. Pfizer's efforts will provide crucial medical training and supply chain support, enhancing healthcare in countries such as Rwanda, Malawi, Ghana, and Senegal.

Pfizer Inc. (NYSE:PFE) announced the acceptance of its 20-valent pneumococcal conjugate vaccine (20vPnC) by the FDA for priority review. This vaccine aims to prevent invasive pneumococcal disease in infants and children aged 6 weeks to 17 years. The FDA's priority review expedites the evaluation process by four months, with a decision expected by April 2023. The vaccine includes 20 serotypes, potentially offering the broadest coverage among pneumococcal vaccines. Results from Phase 3 trials, involving over 4,300 participants, support this submission.

Pfizer Inc. (NYSE: PFE) will host a webcast featuring CEO Albert Bourla at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 3:00 p.m. PST. Investors and the public can access the live discussion via www.pfizer.com/investors. A transcript and replay will be available within 24 hours and accessible for at least 90 days. Pfizer is committed to advancing global health through innovative therapies and vaccines, enhancing the quality and safety of healthcare for patients worldwide.

Pfizer (NYSE: PFE) reported positive top-line results from the Phase 3 BENEGENE-2 study of fidanacogene elaparvovec, a gene therapy for severe hemophilia B. The study demonstrated a 71% reduction in annualized bleeding rate (ABR) compared to standard prophylaxis with Factor IX. Secondary endpoints also showed significant improvements in treated ABR and infusion rates. Fidanacogene elaparvovec was well-tolerated, with a safety profile consistent with earlier studies. Pfizer is advancing multiple gene therapy programs and plans to discuss these results with regulatory authorities in early 2023.