Welcome to our dedicated page for Pfizer news (Ticker: PFE), a resource for investors and traders seeking the latest updates and insights on Pfizer stock.
Pfizer Inc. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) received a Complete Response Letter (CRL) from the FDA concerning their Biologics License Application for somatrogon, a once-weekly treatment for pediatric growth hormone deficiency (GHD). Pfizer will collaborate with the FDA to address the feedback. Despite the setback, somatrogon has gained approvals in several countries, including Japan, Canada, and Australia. The European Commission decision is expected soon. The companies remain committed to advancing somatrogon and addressing unmet medical needs in GHD.
Pfizer Inc. (NYSE: PFE) has received FDA approval for CIBINQO (abrocitinib), a once-daily oral JAK1 inhibitor aimed at adults with refractory, moderate-to-severe atopic dermatitis (AD). CIBINQO is indicated for those who do not respond to existing systemic therapies, including biologics. The approved doses are 50 mg, 100 mg, and 200 mg, with clinical trials involving over 1,600 patients demonstrating significant efficacy in skin clearance and itch relief. The product is expected to be available soon, marking a pivotal moment for patients struggling with this chronic condition.
Pfizer Inc. (NYSE:PFE) announced successful top-line results from a Phase 3 study evaluating the coadministration of PREVNAR 20™, a 20-valent pneumococcal conjugate vaccine, with the Pfizer-BioNTech COVID-19 Vaccine in adults aged 65 and older. The study included 570 participants and demonstrated similar immune responses whether administered together or individually. The safety profile was consistent with previous COVID-19 vaccine booster doses. Pfizer plans to publish detailed findings and is committed to promoting adult immunization amidst ongoing COVID-19 vaccinations.
Pfizer has entered a Development and Option agreement with Acuitas Therapeutics to license lipid nanoparticle (LNP) technology for up to 10 targets in vaccine or therapeutic development. This strategic collaboration enhances Pfizer's mRNA capabilities, building on the success of its COVID-19 vaccine, COMIRNATY®. Chief Scientific Officer Mikael Dolsten emphasized the goal of leveraging mRNA-LNP technology for breakthrough therapeutics. Acuitas, whose technology underpins COMIRNATY®, is also excited to support Pfizer in advancing new vaccine and therapeutic products.
Pfizer (PFE) and Beam Therapeutics (BEAM) announced a four-year research collaboration to develop in vivo base editing programs targeting rare genetic diseases. Beam will receive an upfront payment of $300 million and may earn up to $1.35 billion through future milestone payments. The collaboration aims to advance innovative therapies using Beam's base editing and delivery technologies combined with Pfizer's drug development expertise. This partnership reflects a commitment to addressing unmet medical needs for patients with genetic disorders.
Biohaven Pharmaceutical (BHVN) and Pfizer (PFE) have finalized a collaboration for the commercialization of migraine treatments rimegepant and zavegepant outside the U.S. The deal includes an upfront payment of $500 million to Biohaven, comprising $150 million in cash and $350 million in equity, giving Pfizer 3% ownership in the company. Biohaven is eligible for up to $740 million in future milestones and retains U.S. market rights. This partnership aims to expand the reach of these migraine therapies to millions globally as Biohaven leads ongoing research.
Pfizer and BioNTech have announced a collaboration to develop an mRNA-based vaccine for shingles, targeting the herpes zoster virus. This partnership marks their third collaboration in infectious diseases, building on their previous successes with COVID-19 and influenza vaccines. Under the agreement, BioNTech will receive $225 million upfront, while Pfizer will secure $25 million for its proprietary antigen sequences. Clinical trials are set to begin in the second half of 2022, with cost-sharing and profit-sharing on potential vaccine sales.
Pfizer Inc. (NYSE: PFE) has announced a commitment from the U.S. government to purchase an additional 10 million treatment courses of its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir and ritonavir). This raises the total to 20 million courses, with 10 million set for accelerated delivery by June and the remaining by September 2022. PAXLOVID is FDA authorized for emergency use in high-risk adults and pediatric patients. Pfizer is also increasing production projections from 80 million to 120 million courses for 2022, to meet global demand amid the surge of the Omicron variant.
Pfizer Inc. (NYSE: PFE) invites the public to a webcast featuring CEO Albert Bourla at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 3:00 p.m. EST. Interested individuals can access the webcast on Pfizer's investor relations website. A transcript and replay will be available within 24 hours and accessible for 90 days. Pfizer emphasizes its commitment to innovative healthcare solutions over its 170-year history, actively working to enhance accessibility to treatments and vaccines worldwide.
The U.S. FDA has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include booster doses for individuals aged 12 and older. The booster maintains the same 30-µg dosage as the primary series, addressing rising COVID-19 cases. Additionally, the waiting time for the booster after primary series completion has been reduced from six to five months. A third primary series dose is also authorized for immunocompromised children aged 5-11. Pfizer and BioNTech have delivered 1 billion doses to low- and middle-income countries, with an additional billion expected in 2022.