Pfizer Stock Price, News & Analysis

Pfizer (NYSE: PFE) announced that the European Commission has approved LORVIQUA (lorlatinib) for treating adults with ALK-positive advanced non-small cell lung cancer (NSCLC) previously untreated with an ALK inhibitor. This decision was based on the Phase 3 CROWN trial, demonstrating a 72% reduction in the risk of disease progression or death compared to XALKORI (crizotinib). The trial also reported a confirmed objective response rate of 76%, highlighting LORVIQUA's efficacy in patients with brain metastases.

Pfizer announced that the European Medicines Agency's CHMP has recommended conditional marketing authorization for PAXLOVID™ to treat COVID-19 in adults not requiring supplemental oxygen. If approved, it would be the first oral COVID-19 treatment recommended in the EU. The recommendation is based on clinical trial data showing PAXLOVID reduced the risk of hospitalization or death by 89% when administered within three days of symptom onset. Pfizer aims to produce up to 120 million treatment courses and is committed to equitable access worldwide.

Pfizer and BioNTech have commenced a clinical trial for an Omicron-based COVID-19 vaccine, evaluating safety and immunogenicity in 1,420 healthy adults aged 18-55. This study will assess various dosing regimens of the existing vaccine alongside the Omicron variant candidate. With the ongoing risk of waning vaccine effectiveness against emerging variants, the companies aim to provide longer-lasting protection. The trial is part of an extensive strategy to address evolving COVID-19 challenges while maintaining production capabilities of the current vaccine.

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.