Pfizer Stock Price, News & Analysis

Pfizer Inc. (NYSE:PFE) announced that its RSV vaccine candidate, RSVpreF, received Breakthrough Therapy Designation from the FDA for preventing RSV-associated respiratory illness in infants via maternal immunization. The designation is based on Phase 2b study results, focusing on safety and immunogenicity. Pfizer anticipates future publications regarding the trial outcomes. Approximately 2.1 million outpatient visits occur annually in the U.S. due to RSV in young children, highlighting the significance of this potential vaccine.

Pfizer announced findings from the CLOVER trial, a Phase 3 study evaluating its C. difficile vaccine candidate (PF-06425090). Although the trial did not meet its primary endpoint, it showed promising results in secondary endpoints, indicating 100% efficacy in preventing medically attended infections and a significant reduction in disease duration. The vaccine was well tolerated with a favorable safety profile. Pfizer is assessing the next steps for the vaccine program in coordination with regulatory agencies.

Pfizer Inc. (NYSE: PFE) will host a webcast featuring its executives, Angela Hwang, Andy Schmeltz, and Suneet Varma, at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 9:50 a.m. EST. Investors and the public can access the live discussion through www.pfizer.com/investors. A transcript and replay will be available within 24 hours for 90 days. Pfizer focuses on delivering therapies that significantly improve patients’ lives and routinely provides important updates on its website.

Biohaven and Pfizer have received a positive opinion from the CHMP for rimegepant, a new treatment for migraines, recommending its 75 mg dose for both acute and preventive use in adults. This marks a significant advancement, as rimegepant is set to become the first oral CGRP receptor antagonist in the EU under the trade name VYDURA™, pending European Commission approval. The CHMP's recommendation was based on results from multiple Phase 3 studies that demonstrated rimegepant's safety and efficacy in treating migraines, addressing a crucial unmet need for patients.

Pfizer Inc. (NYSE: PFE) will host a webcast featuring keynote speaker Lidia Fonseca, Chief Digital and Technology Officer, during the Truist Securities Life Sciences AI Symposium on March 1, 2022, at 12:30 p.m. EST. Interested parties can access the webcast through www.pfizer.com/investors. A transcript and replay will be available on the site within 24 hours of the event and will remain accessible for at least 90 days. Pfizer focuses on delivering innovative therapies that improve global health outcomes.

Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) received EU marketing authorization for NGENLA™ (somatrogon), a long-acting growth hormone replacement therapy for children with growth hormone deficiency (GHD). This innovative treatment reduces injection frequency from daily to weekly, potentially enhancing patient adherence and quality of life. The approval is based on the positive results from a Phase 3 study demonstrating NGENLA's non-inferiority to GENOTROPIN^® (somatropin) in height velocity. NGENLA is now available across all EU states, Iceland, Norway, and Liechtenstein.

Pfizer Inc. (NYSE:PFE) received approval from the European Medicines Agency (EMA) for APEXXNAR, a 20-valent pneumococcal conjugate vaccine aimed at adults 18 and older. This vaccine provides protection against 20 serotypes linked to invasive pneumococcal disease and pneumonia, representing the most comprehensive serotype coverage available in Europe. The approval follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use on December 17, 2021, and is based on extensive clinical trials involving over 6,000 adult participants.

Biohaven Pharmaceutical and Pfizer announced successful Phase 3 trial results for rimegepant, aimed at treating migraines in 1,431 adults across the Asia-Pacific region. This trial, led by BioShin Limited, confirmed that a single 75 mg dose significantly alleviated migraine symptoms within two hours (p<0.0001) and showed sustained effectiveness for up to 48 hours. Following this success, rimegepant, currently marketed as Nurtec ODT in the U.S., has regulatory applications pending in Europe. The partnership aims to expand the drug's availability, particularly in regions where migraine remains prevalent.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced plans to extend a rolling submission to the FDA to amend the Emergency Use Authorization for their COVID-19 vaccine, targeting children aged 6 months to 4 years. Ongoing trials are evaluating a three-dose regimen, with data expected in early April, aimed to enhance protection amidst the Omicron surge. The study involves around 8,300 children and is supported by an independent Data Monitoring Committee, underscoring the vaccine's tolerability and potential efficacy.