Pfizer Stock Price, News & Analysis

Pfizer Inc. (NYSE: PFE) has received approval from the European Commission for XELJANZ^® (tofacitinib) for treating active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients aged two years and older who have not responded adequately to previous disease-modifying antirheumatic drug (DMARD) therapies. The approval includes a new oral solution and a once-daily tablet formulation. XELJANZ is the first JAK inhibitor approved in Europe for these indications and has been studied across over 50 clinical trials globally.

Pfizer (PFE) and BioNTech (BNTX) have submitted Phase 1 data to the FDA for a booster dose of their COVID-19 vaccine (BNT162b2). This submission follows successful Phase 1 trials showing significantly higher neutralizing antibodies after a third dose compared to the two-dose schedule. The companies plan to also submit this data to the EMA and other authorities soon. Although the booster is not yet widely authorized in the U.S., it was recently approved for immunocompromised individuals. Further Phase 3 results are expected shortly.

Pfizer Inc. (NYSE:PFE) has received FDA approval for TICOVAC™, a vaccine for tick-borne encephalitis (TBE), aimed at individuals aged 1 and older. This makes TICOVAC™ the first FDA-approved vaccine to protect U.S. residents traveling to TBE-endemic areas. With over 170 million doses distributed globally over the past 45 years, the vaccine shows a seropositivity rate of 99.5% in children and 98.7-100% in adults after three doses. While TBE is not endemic in the U.S., it poses significant health risks in over 35 countries worldwide.

Pfizer Inc. (NYSE: PFE) announced positive top-line results from the Phase 2b/3 ALLEGRO trial for ritlecitinib, an oral treatment for alopecia areata. The study met its primary endpoint, showing significant scalp hair regrowth in patients with at least 50% hair loss. Ritlecitinib’s safety profile was consistent with earlier studies, with common adverse events including nasopharyngitis and headache. There were no major adverse cardiac events reported. Full study results will be published, supporting future regulatory filings.

Pfizer Inc. (NYSE: PFE) reported a substantial 92% revenue increase in Q2 2021, totaling $18.98 billion, attributed to strong sales of its COVID-19 vaccine, BNT162b2, which alone contributed $7.8 billion. The company raised its 2021 financial guidance, now expecting revenues of $78.0 to $80.0 billion. Adjusted diluted EPS is projected between $3.95 and $4.05, reflecting a 77% increase from 2020. The company also reported a 10% operational growth in its business excluding the vaccine. Pfizer aims for a 6% CAGR through 2025, buoyed by promising clinical pipelines and revenue forecasts.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced the U.S. government's purchase of an additional 200 million doses of their COVID-19 vaccine. This increases the total to 500 million doses under their supply agreement. The companies plan to deliver 110 million doses by December 31, 2021, and the remaining doses by April 30, 2022. The U.S. government will continue to provide the vaccine for free. The vaccine remains under Emergency Use Authorization and is aimed at preventing COVID-19.

Pfizer (NYSE: PFE) announced the FDA will not meet the PDUFA goal dates for its New Drug Application for abrocitinib, aimed at treating moderate to severe atopic dermatitis, and the supplemental application for XELJANZ/XELJANZ XR (tofacitinib) for active ankylosing spondylitis. The delay is attributed to the FDA's ongoing review of Pfizer's post-marketing safety study for tofacitinib in rheumatoid arthritis. Pfizer remains confident in the benefit-risk profiles of both drugs.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) have signed a letter of intent with The Biovac Institute to manufacture and distribute the Pfizer-BioNTech COVID-19 Vaccine in Africa. Biovac will join Pfizer's global supply chain, enhancing production capabilities across three continents with over 20 facilities. Production is set to begin in 2022, aiming for more than 100 million doses annually for the African Union. This collaboration underscores Pfizer's commitment to equitable vaccine access and explores further partnerships in Latin America.