Pfizer Inc. - PFE STOCK NEWS

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.

Pfizer (NYSE: PFE) and EMD Serono report the publication of Phase III JAVELIN Bladder 100 study results, demonstrating BAVENCIO® (avelumab) as an effective first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC). The study highlighted a significant overall survival (OS) improvement, with 71.3% of BAVENCIO patients alive at one year compared to 58.4% on best supportive care (BSC). FDA approved BAVENCIO in June for this use, based on these results, marking a potential shift in UC treatment protocols.

Find Your MBC Voice, an initiative by Pfizer (NYSE:PFE), is launched with television host Meredith Vieira to empower those living with metastatic breast cancer (mBC). The program offers resources, including a Treatment Discussion Guide, to facilitate informed discussions between patients and doctors about treatment options. An accompanying feature, WMBC Radio, will present insights into managing mBC through interviews with advocates and healthcare professionals. Pfizer emphasizes the importance of empowering patients to advocate for their health.

The FDA has approved BAVENCIO® (avelumab) for maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC) who have not progressed after first-line platinum-containing chemotherapy. This approval follows the Phase III JAVELIN Bladder 100 study, which showed a median overall survival of 21.4 months with BAVENCIO compared to 14.3 months with best supportive care alone, representing a 31% reduction in death risk. This makes avelumab the first immunotherapy to significantly improve survival in this setting, marking a crucial advancement in bladder cancer treatment.