Pfizer Stock Price, News & Analysis

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.

ViiV Healthcare, majority-owned by GSK and partnered with Pfizer, has received approval from the European Commission to update product guidelines for Vocabria and Rekambys. This allows HIV patients the option to start treatment directly with injections, bypassing the oral lead-in phase. The change aims to simplify the treatment initiation process, as both methods have shown similar efficacy and safety. This decision is based on positive phase III clinical trial results that support the new regimen.

ViiV Healthcare announced positive interim results from the CARISEL study evaluating a long-acting HIV treatment regimen of Vocabria (cabotegravir) and Rekambys (rilpivirine). Conducted during the COVID-19 pandemic, the study showed 97% of participants found the bi-monthly injection visits acceptable. Healthcare teams across five European countries largely agreed on the regimen's feasibility, with mean scores of 4.6 for acceptability. Additionally, implementation concerns among healthcare teams decreased significantly over time, indicating strong potential for this innovative treatment in diverse settings.

Pfizer and BioNTech announced FDA's Vaccines Advisory Committee voted 17-0, with 1 abstention, to recommend Emergency Use Authorization (EUA) for their COVID-19 vaccine for children aged 5 to <12 years. This vaccine demonstrated a 90.7% efficacy rate in clinical trials conducted during the Delta variant surge, using a 10-µg dosage. If authorized, this will be the first COVID-19 vaccine approved for this age group in the U.S. The companies anticipate starting vaccine distribution immediately upon authorization, ensuring free access for eligible children.