Pfizer Inc. - PFE STOCK NEWS

Pfizer and BioNTech announced an agreement with the European Commission to deliver over 200 million additional doses of their COVID-19 vaccine, COMIRNATY, in 2022. This brings the total planned doses for the year to more than 650 million. The contract will include potential vaccines adapted for the Omicron variant at no additional cost. Pfizer and BioNTech had previously agreed to supply 900 million doses to the EC for 2022 and 2023, with an option for up to an additional 900 million doses.

Pfizer (NYSE: PFE) received favorable advice from the European Medicines Agency's CHMP for its antiviral treatment PAXLOVID, indicating its use for adults at increased risk of severe COVID-19. The CHMP recommends timely administration within five days post-diagnosis. This advice supports EU member states in potential emergency use before official marketing authorization. PAXLOVID demonstrated an 89% reduction in hospitalization or death in clinical trials compared to placebo. Pfizer aims to ensure equitable access and plans to invest up to $1 billion in manufacturing and distribution.

Pfizer (NYSE: PFE) announced FDA approval for XELJANZ® (tofacitinib) to treat adults with active ankylosing spondylitis (AS) who have inadequate response or intolerance to TNF blockers. This approval is based on a Phase 3 study involving 269 patients, where tofacitinib showed significant efficacy over placebo (ASAS20 response: 56.4% vs. 29.4%, p<0.0001). XELJANZ is notable as the first oral JAK inhibitor approved for five immuno-inflammatory indications in the U.S., providing a non-injection treatment option for AS, a condition affecting over 350,000 Americans.

Pfizer (NYSE: PFE) announced final results from its Phase 2/3 EPIC-HR study, confirming PAXLOVID's effectiveness in reducing hospitalization or death risk by 89% when administered within three days of COVID-19 symptom onset. The data will support ongoing FDA Emergency Use Authorization applications. In a secondary endpoint, PAXLOVID also reduced the risk by 88% when given within five days. Furthermore, the EPIC-SR study showed a 70% reduction in hospitalization among standard-risk adults, although it did not meet its primary endpoint for symptom alleviation. Both trials indicate significant antiviral activity against SARS-CoV-2 variants.

Pfizer has proposed to acquire Arena Pharmaceuticals for $100 per share, totaling approximately $6.7 billion. This acquisition aims to enhance Pfizer's portfolio in immuno-inflammatory diseases, leveraging Arena’s innovative pipeline, including etrasimod, currently under development for various conditions. The deal has received unanimous approval from both companies' boards and is subject to regulatory approvals and Arena shareholders' consent. An analyst call is scheduled for today at 10am EST.

Pfizer (NYSE: PFE) and Sangamo Therapeutics (NASDAQ: SGMO) have released updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, a gene therapy for severe hemophilia A. At 104 weeks, patients in the highest dose cohort exhibited a mean factor VIII activity of 25.4% with no annualized bleeding in the first year post-infusion. However, the Phase 3 AFFINE trial has encountered a clinical hold by the FDA following observations of elevated FVIII levels in treated patients. The ongoing studies aim to evaluate long-term efficacy and safety of this investigational therapy.

Pfizer Inc. (NYSE: PFE) has announced a quarterly cash dividend increase to $0.40 per share for the first quarter of 2022. This dividend is payable on March 4, 2022, to shareholders on record by January 28, 2022. This marks the 333rd consecutive dividend payout by the company. Pfizer's leadership, including Dr. Albert Bourla, emphasized that this increase reflects strong financial performance and confidence in the company’s product portfolio and research pipeline.

Pfizer Inc. (NYSE: PFE) announced that the European Commission approved its oral medication Cibinqo® (abrocitinib) for treating moderate-to-severe atopic dermatitis in adults. Cibinqo, a Janus kinase 1 inhibitor, is available in 100 mg and 200 mg doses, with a 50 mg dose for patients with renal impairment. The approval is backed by five clinical studies with over 2,800 patients, showing significant symptom improvement versus placebo and a favorable safety profile. This marks a vital treatment innovation for patients suffering from this chronic condition.

The U.S. FDA has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine booster, now available for individuals aged 16 and older. Administered at least six months post-primary series, the booster has shown a 95% efficacy in combating symptomatic COVID-19 compared to non-booster recipients. Pfizer and BioNTech plan to submit a supplemental Biologics License Application to formalize this authorization. The companies will continue supplying vaccines under existing agreements with the U.S. government through April 2022.