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. (PFE) is a global biopharmaceutical leader driving innovations in vaccine development and therapeutic treatments. This news hub provides investors and industry professionals with timely updates on corporate developments, regulatory milestones, and market strategies.
Access official press releases, earnings reports, and analysis of Pfizer's clinical trial progress. Our curated collection covers FDA approvals, partnership announcements, and research breakthroughs across oncology, immunology, and infectious disease portfolios.
Key updates include quarterly financial results, manufacturing expansions, and strategic collaborations shaping the pharmaceutical landscape. Bookmark this page for reliable insights into one of healthcare's most influential companies, with content organized for efficient navigation across devices.
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.
CStone Pharmaceuticals has finalized a US$200 million share subscription agreement with an affiliate of Pfizer (PFE), enhancing their strategic collaboration announced on September 30, 2020. Pfizer will acquire approximately 115.9 million shares at HK$13.37 per share, representing about 9.90% of CStone's increased capital. This partnership aims to develop and commercialize oncology therapies in Greater China, including granting Pfizer a license for sugemalimab, CStone's key asset.
The German Breast Group (GBG) and Pfizer announced that their Phase 3 PENELOPE-B trial did not improve invasive disease-free survival (iDFS) in women with hormone receptor-positive, HER2-negative early breast cancer with residual disease post-chemotherapy. No unexpected safety issues were reported. The trial compared palbociclib combined with standard endocrine therapy to placebo and showed that while the results were disappointing, further analysis of biomarkers may yield insights for future research. Findings will be presented at a forthcoming medical congress.
Pfizer (NYSE: PFE) and OPKO Health (NASDAQ: OPK) announced successful results from the Phase 3 study C0311002, evaluating somatrogon, a once-weekly treatment for growth hormone deficiency (GHD) in children aged 3 to <18 years. The study met its primary endpoint, demonstrating a significant reduction in treatment burden compared to daily somatropin, with a mean Life Interference score of 8.63 versus 24.13 (p<0.0001). No serious adverse events occurred, and the companies aim to explore additional indications for somatrogon.
Pfizer (PFE) and Sangamo Therapeutics (SGMO) announced the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec, a gene therapy for hemophilia A. This global, open-label study aims to evaluate the therapy's efficacy and safety, focusing on annual bleed rates over 12 months. The study follows promising Phase 1/2 results, indicating sustained Factor VIII activity and reduced bleeds. Sangamo has now earned a $30 million milestone payment as part of their collaboration, which could total $300 million.
