Pfizer Inc. - PFE STOCK NEWS

Pfizer Inc. (NYSE: PFE) reported positive top-line results from the Phase 3 JADE REGIMEN study of abrocitinib, a JAK1 inhibitor for moderate to severe atopic dermatitis. The 52-week study showed significant efficacy, with 81.1% of patients on 200mg and 57.4% on 100mg preventing flares, compared to 19.1% on placebo (p<0.0001). The study also demonstrated a higher percentage of patients maintaining an Investigator's Global Assessment (IGA) score of clear or almost clear. Out of 1,233 participants, 798 (64.7%) had positive responses during the induction phase, exceeding expectations.

Pfizer (PFE) and BioNTech have finalized a supply agreement with the European Commission for 200 million doses of their BNT162b2 COVID-19 vaccine, with an option for an additional 100 million doses. Deliveries are expected to commence by the end of 2020, contingent on successful clinical trials and regulatory approval. The vaccine will be manufactured in Germany and Belgium. This supply agreement marks a significant step in making a COVID-19 vaccine accessible in the EU, aiming to protect vulnerable populations amidst the pandemic.

Pfizer (PFE) and BioNTech announced that their mRNA-based vaccine candidate, BNT162b2, has shown efficacy against COVID-19 in a Phase 3 clinical trial. The first interim analysis reported a vaccine efficacy rate above 90% based on 94 cases, achieved 7 days after the second dose. The trial has enrolled 43,538 participants to date, with diverse backgrounds. Pfizer plans to produce up to 50 million doses in 2020 and 1.3 billion doses in 2021. The companies are preparing data for regulatory submission and will continue to collect safety and efficacy data.

Pfizer Inc. (NYSE: PFE) announced positive Phase 3 study results for tofacitinib in adults with active ankylosing spondylitis, demonstrating significant efficacy compared to placebo. The study, which included 270 participants, met both its primary and key secondary endpoints, showing ASAS20 responses of 56.4% versus 29.4% for placebo, and ASAS40 responses of 40.6% compared to 12.5%, respectively. Tofacitinib is not yet FDA-approved for this indication, but a presentation is scheduled for November 9 during ACR Convergence. The company anticipates FDA review with a PDUFA goal date in Q2 2021.

Astellas Pharma announced the approval of XTANDI^® (enzalutamide) by the China National Medical Products Administration for treating non-metastatic castration-resistant prostate cancer (nmCRPC) in adult men. This marks the second approved indication in China, complementing its existing use for metastatic castration-resistant prostate cancer. The approval is based on the PROSPER trial, which showed a median metastasis-free survival of 36.6 months for enzalutamide plus ADT, versus 14.7 months for placebo. Astellas anticipates reflecting this approval in its financial forecast for the fiscal year ending March 31, 2021.

Mylan and Pfizer announced that the U.S. Federal Trade Commission accepted a proposed consent order concluding the FTC's review of Mylan's merger with Pfizer's Upjohn Business. All antitrust clearances have now been obtained. The transaction, structured as a Reverse Morris Trust, is set to close on November 16, 2020, creating Viatris Inc. Pfizer shareholders will receive 57% of Viatris shares, while Mylan shareholders will own 43%. The merger aims to enhance shareholder value and focus on healthcare innovations.

Pfizer Inc. (NYSE: PFE) announced that the FDA has accepted its New Drug Application for abrocitinib, an oral JAK1 inhibitor for moderate to severe atopic dermatitis in patients aged 12 and older. The FDA granted Priority Review designation, with a decision expected in April 2021. The EMA has also accepted the Marketing Authorization Application. The filing is based on a robust Phase 3 clinical trial program showing significant improvements in skin clearance and itch relief compared to placebo. Abrocitinib is expected to offer a new treatment option for patients with substantial unmet needs.

Pfizer Inc. (NYSE: PFE) reported Q3 2020 results, reflecting a 4% revenue decline to $12.1 billion, influenced by COVID-19. The Biopharma segment grew 4%, countering an 18% drop in Upjohn revenues, which suffered from generic competition. Net income fell 71% year-over-year to $2.2 billion. Pfizer updated 2020 guidance, projecting revenues of $48.8 to $49.5 billion and adjusted diluted EPS of $2.88 to $2.93. Ongoing investments in R&D are aimed at combating COVID-19, alongside a strategic transition to a more agile, science-driven company.

Pfizer (NYSE:PFE) announced results from its Phase 3 trial (NCT03760146) of the 20-valent pneumococcal conjugate vaccine (20vPnC) for adults aged 18 and over, showing robust immune responses across all evaluated age cohorts. The trial involved 902 participants, demonstrating noninferiority in immune responses compared to Prevnar 13 and PPSV23. Pfizer has submitted a biologics license application to the FDA and plans to file for European marketing authorization in Q1 2021. The Phase 2 study in infants indicated a similar safety profile and effective immune response.