Pfizer Stock Price, News & Analysis

Pfizer has received marketing authorization from the UK MHRA for CIBINQO (abrocitinib), a once-daily oral JAK1 inhibitor. This drug is approved for treating moderate to severe atopic dermatitis in patients aged 12 and older who require systemic therapy. The authorized doses are 100mg and 200mg. This marks the first marketing authorization globally for abrocitinib, following its PIM designation last year. Pfizer aims to collaborate with NICE and the Scottish Medicines Consortium to ensure patient access to this treatment.

Pfizer Inc. (NYSE: PFE) invites the public to join two webcasts featuring company executives at healthcare conferences. Frank D’Amelio, CFO, will discuss at the Morgan Stanley 19th Annual Global Healthcare Conference on September 14, 2021, at 10:15 a.m. EDT. Angela Hwang, Group President, will speak at the BofA Global Healthcare Conference on September 15, 2021, at 11:45 a.m. EDT. Webcast access and registration details can be found on Pfizer's website, with transcripts available within 24 hours post-event.

Pfizer has initiated the RENOIR Phase 3 clinical trial for its RSV bivalent prefusion F subunit vaccine candidate in adults aged 60 and older. This trial aims to enroll approximately 30,000 participants and assess the vaccine's safety and efficacy against severe respiratory illness caused by RSV, which poses significant risks to older adults. With no current vaccine available, the trial addresses an urgent medical need, particularly as RSV leads to over 14,000 deaths annually in the U.S. among older adults.

Pfizer Inc. (NYSE: PFE) reported that the JADE DARE trial for abrocitinib met its co-primary and key secondary endpoints. This Phase 3 study demonstrated that abrocitinib, when dosed at 200mg daily, was statistically superior to dupilumab (300mg) for treating moderate to severe atopic dermatitis. While the safety profile was consistent with earlier studies, a higher percentage of patients on abrocitinib experienced adverse events. The findings, expected to be presented at a scientific meeting, underline abrocitinib's potential benefits for patients.

Pfizer Inc. (NYSE: PFE) has appointed Aamir Malik as the new Executive Vice President and Chief Business Innovation Officer, effective August 30, 2021. Malik, previously a Managing Partner at McKinsey & Company, will report to CEO Albert Bourla and succeed John Young as he retires after 34 years. In his new role, Malik will be responsible for the company’s strategy, business development, and innovative partnerships globally. Bourla highlighted Malik's extensive experience in driving growth and improving patient care during the announcement.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have signed a letter of intent with Eurofarma Laboratórios SA to manufacture their COVID-19 vaccine, COMIRNATY^®, for distribution in Latin America. Eurofarma will initiate technical transfer and on-site development immediately, with finished dose production expected to exceed 100 million doses annually, beginning in 2022. This collaboration aims to enhance equitable access to vaccines in the region, contributing to a total of 3 billion doses planned for global distribution by year-end 2021.

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced the initiation of a supplemental Biologics License Application for a third dose of COMIRNATY. New Phase 3 trial data show the booster dose significantly increases SARS-CoV-2 neutralizing antibody titers, achieving levels 3.3 times higher than the second dose. The companies plan to submit these findings to the European Medicines Agency and other regulatory bodies shortly. Adverse events observed were mild to moderate, with a low incidence of severe reactions, consistent with previous clinical data.

Pfizer and BioNTech received FDA approval for COMIRNATY^®, making it the first FDA-approved COVID-19 vaccine for individuals aged 16 and older. This vaccine has been available under Emergency Use Authorization since December 2020. The approval validates the vaccine's efficacy and safety, supported by long-term Phase 3 trial data. Approximately 60% of eligible Americans are fully vaccinated, and the companies aim to enhance vaccine confidence. COMIRNATY is also authorized for individuals aged 12-15 under EUA and will seek further approvals for booster doses and younger age groups.

Pfizer (NYSE: PFE) has announced its definitive agreement to acquire Trillium Therapeutics (NASDAQ/TSX: TRIL) for an equity value of $2.26 billion, equating to $18.50 per share, marking a significant 118% premium. The acquisition aims to enhance Pfizer's oncology portfolio, especially in treating blood cancers, by integrating Trillium's lead molecules, TTI-622 and TTI-621, which target the SIRPα-CD47 axis. These molecules are in advanced clinical trials and show promise as therapies for various hematological malignancies.