Pfizer Inc. - PFE STOCK NEWS

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.

Pfizer (NYSE: PFE) will host a webcast featuring its Hospital leadership team, including Angela Lukin, Annaliesa Anderson, and James Rusnak, at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 1:00 p.m. EST. Investors can access the webcast via www.pfizer.com/investors. A transcript and replay will be available within 24 hours and accessible for at least 90 days. Pfizer aims to enhance patient lives through innovative medicines and vaccines, collaborating globally to ensure access to healthcare.

Pfizer reported full-year 2021 revenues of $81.3 billion, marking a 92% operational growth, with fourth-quarter revenues at $23.8 billion, reflecting a 106% increase. Excluding COVID-19 vaccine Comirnaty and treatment Paxlovid, operational revenue growth was 6% for the year, but declined by 2% in Q4. The adjusted diluted EPS for 2021 was $4.42, and Pfizer issued 2022 guidance expecting revenues between $98 billion and $102 billion, alongside adjusted diluted EPS of $6.35 to $6.55. The guidance includes anticipated revenues of $32 billion from Comirnaty and $22 billion from Paxlovid.

ViiV Healthcare, majority-owned by GlaxoSmithKline (GSK), presented groundbreaking research at CROI 2022, emphasizing long-acting HIV treatments. Key findings highlighted include:

• Cabenuva administered every two months shows sustained efficacy in virologically suppressed adults.
• Dovato demonstrates long-term efficacy over 144 weeks compared to TAF-based treatments.
• Insights from the MOCHA study reveal adolescent perspectives on long-acting injectables.

These results reinforce ViiV's commitment to innovative HIV treatment and prevention.

Pfizer and BioNTech have initiated a rolling submission to amend the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include children aged 6 months to 4 years, at the request of the FDA. This application seeks authorization for two 3 µg doses as part of a planned three-dose series. With over 10.6 million pediatric COVID-19 cases in the U.S., this vaccine could be the first available for children under 5. The companies aim to submit additional data for a third dose in the coming months, enhancing protection against current and future variants.

Pfizer Inc. (NYSE: PFE) announces the appointment of William Pao, M.D., Ph.D., as Executive Vice President and Chief Development Officer, effective March 21, 2022. Dr. Pao, previously at Roche, will lead Pfizer's Global Product Development, overseeing the clinical advancement of innovative medicines. He succeeds Rod MacKenzie, who is retiring after 35 years. Dr. Pao's extensive experience in drug development is expected to enhance Pfizer's focus on breakthrough therapies and vaccines.