Pfizer Inc. - PFE STOCK NEWS

Pfizer Inc. (NYSE: PFE) has announced the retirement of Frank D’Amelio, CFO, after nearly 15 years. D’Amelio will assist in the transition as Pfizer conducts an external search for his successor. Mike McDermott, previously EVP Chief Global Supply Officer, has been appointed to the Executive Leadership Team. Under D’Amelio, Pfizer achieved $150 billion in market cap growth and engaged in $200 billion in acquisitions and partnerships. McDermott played a crucial role in ramping up vaccine production during the COVID-19 pandemic.

Pfizer is seeking Emergency Use Authorization (EUA) for its investigational oral antiviral, PAXLOVID™ (PF-07321332; ritonavir), aimed at treating mild to moderate COVID-19 in high-risk patients. The request is based on an interim analysis from the Phase 2/3 EPIC-HR study, showing an 89% reduction in COVID-19-related hospitalizations or deaths compared to placebo. Rolling submissions for the drug have begun in countries like the UK and Australia, with further submissions planned globally. Pfizer is investing up to $1 billion to support the manufacturing and distribution of PAXLOVID.

Pfizer Inc. (NYSE: PFE) has signed a voluntary license agreement with the Medicines Patent Pool (MPP) to enhance access to its COVID-19 oral antiviral treatment, PF-07321332. This agreement will empower qualified generic manufacturers to distribute the treatment in 95 countries, covering around 53% of the global population, especially in low- and middle-income nations. Interim data from the Phase 2/3 EPIC-HR study indicates a remarkable 89% reduction in COVID-19-related hospitalizations or deaths among treated high-risk patients.

Pfizer Inc. (NYSE: PFE) announces a webcast featuring key executives, including Chief Scientific Officer Mikael Dolsten, on November 17, 2021, at 12:30 p.m. EST during the Wolfe Research Healthcare Conference 2021. The session will cover advances in research and development, with a focus on their product pipeline.

Investors can access the live webcast and later replay on Pfizer's investor website, with transcripts available within 24 hours. Pfizer continues to emphasize its commitment to innovative healthcare solutions and improving patient lives globally.

Biohaven and Pfizer announced a strategic collaboration for the commercialization of rimegepant outside the U.S. Rimegepant, known as Nurtec® ODT in the U.S., is indicated for both acute and preventive migraine treatment. Pfizer will pay $500 million upfront, with $350 million in equity purchase at a 25% premium, and may provide up to $740 million in milestones. Biohaven will retain responsibility for further development while Pfizer will handle commercialization globally, excluding the U.S. This partnership aims to enhance access to innovative migraine treatments worldwide.

Pfizer's investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), demonstrated an 89% reduction in the risk of hospitalization or death in high-risk adults with COVID-19, as per interim data from the Phase 2/3 EPIC-HR study. The study showed no deaths in patients receiving PAXLOVID™ compared to 10 in the placebo group. Pfizer plans to submit data for Emergency Use Authorization to the U.S. FDA. The positive results support the potential for PAXLOVID™ to serve as a breakthrough treatment for COVID-19.

Pfizer reported third-quarter 2021 revenues of $24.1 billion, a 134% increase year-over-year, driven by the success of the Comirnaty vaccine, which contributed $13 billion. Excluding Comirnaty, revenues still grew 7% to $11.1 billion. The reported diluted EPS was $1.42, with adjusted EPS at $1.34. Pfizer raised its full-year revenue guidance to $81-82 billion and adjusted EPS to $4.13-4.18. The company anticipates around $36 billion in revenue from Comirnaty for 2021, with plans to deliver 2.3 billion doses globally.

The U.S. FDA has granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for children aged 5 to 11 years. This milestone is supported by clinical data indicating a 90.7% vaccine efficacy among participants when Delta was the prevalent strain. The vaccine demonstrates a favorable safety profile and will be administered in two 10-µg doses. With this authorization, Pfizer-BioNTech's vaccine is now the only option for this age group in the U.S., aiming to protect millions of school-aged children from COVID-19.

Pfizer and BioNTech announced the U.S. government's purchase of an additional 50 million COVID-19 vaccine doses, bringing the total to 600 million under the existing supply agreement. This move supports pediatric vaccination efforts, particularly for children under 5, pending regulatory authorization. Deliveries are anticipated by April 30, 2022. Furthermore, the companies aim to manufacture 4 billion doses worldwide in 2022, with a commitment to provide vaccines to low-income countries. The FDA has been approached for Emergency Use Authorization for children aged 5 to under 12 years.