Pfizer Inc. - PFE STOCK NEWS

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.

ViiV Healthcare announced the launch of a new weekly podcast titled Being Seen, which explores cultural representations relevant to the queer and gay Black male experience. Hosted by Darnell Moore, the podcast aims to change perceptions and reduce stigma surrounding this community, emphasizing their stories and challenges. Available starting October 6, Being Seen features conversations with various artists and activists. This initiative aligns with ViiV's focus on addressing HIV-related disparities and amplifying marginalized voices in society.

Pfizer Inc. (NYSE: PFE) announced that its gene therapy candidate PF-06939926 for Duchenne muscular dystrophy (DMD) has received Fast Track designation from the FDA. This designation aims to accelerate development for serious conditions with unmet needs. Preliminary data from a Phase 1b study indicated that PF-06939926 was well-tolerated and showed sustained dystrophin expression over 12 months. Pfizer aims to advance to a Phase 3 program swiftly, highlighting the urgent need for effective treatment options for DMD, which affects approximately 10,000 to 12,000 individuals in the U.S.

Pfizer Inc. (NYSE: PFE) has received FDA approval for XELJANZ® (tofacitinib) to treat children and adolescents aged 2 and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). The approval includes both a tablet and an oral solution formulation. This marks XELJANZ as the first approved Janus kinase (JAK) inhibitor for pcJIA in the U.S. The approval was based on a Phase 3 study demonstrating significant efficacy, with disease flare rates lower in tofacitinib-treated patients compared to placebo. XELJANZ tablets are available now, while the oral solution is expected by Q1 2021.