Pfizer - PFE STOCK NEWS

Pfizer Inc. (NYSE:PFE) has released promising safety and clinical response results from its Phase 1 study of PF-06863135, a bispecific antibody targeting B-cell maturation antigen (BCMA) for treating relapsed or refractory multiple myeloma. Involving 30 patients, the study showed no dose-limiting toxicities and an 83% clinical response rate at the highest dose level of 1,000 μg/kg. Cytokine release syndrome was reported but primarily mild. The data suggests PF-06863135 could be a significant advancement in multiple myeloma treatment, supporting its further development.

Pfizer (NYSE: PFE) and Sangamo Therapeutics have shared updated data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, a gene therapy for severe hemophilia A, presented at the 62nd American Society for Hematology Annual meeting. The study’s high-dose cohort (3 x 10¹³ vg/kg) showed sustained factor VIII activity for over a year, with a median FVIII activity of 56.9% and no bleeding events during the first year. Adverse events were minor, and the therapy was generally well tolerated. A pivotal Phase 3 study is underway, with results expected by 2022.

Pfizer and BioNTech announced that the U.K.'s MHRA has granted a temporary Emergency Use Authorization for their COVID-19 mRNA vaccine, BNT162b2. This is a historic milestone as it is the first such authorization following a global Phase 3 trial showing a 95% efficacy rate. The companies plan to deliver up to 40 million doses, prioritizing high-risk populations as per U.K. guidelines. The regulatory review is ongoing in other regions, including the U.S. and EU, with Pfizer's extensive distribution capabilities expected to facilitate rapid vaccine rollout globally.

Pfizer Inc. (NYSE: PFE) has initiated the Phase 3 BASIS study for marstacimab (PF-06741086), aimed at treating severe hemophilia A or B. This multicenter trial will assess annualized bleed rate (ABR) over 12 months among participants undergoing prophylactic treatment. Previous Phase 2 results indicated a significant reduction in ABR (>75%) and no serious adverse events. Marstacimab could potentially eliminate the need for factor replacement therapy, offering a novel subcutaneous treatment option for patients.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced their request for Emergency Use Authorization (EUA) of the mRNA vaccine candidate BNT162b2 against SARS-CoV-2. The vaccine demonstrated 95% efficacy in Phase 3 trials, involving over 43,000 participants. Safety data shows no serious concerns. If authorized, the companies can distribute 50 million doses globally in 2020 and 1.3 billion by the end of 2021. The collaboration aims to facilitate rapid global vaccine distribution amidst rising COVID-19 cases.

Pfizer Inc. (NYSE:PFE) announced significant results from the Phase 3 CROWN trial of LORBRENA® (lorlatinib) versus XALKORI® (crizotinib) for previously untreated ALK-positive advanced non-small cell lung cancer (NSCLC). LORBRENA showed a statistically significant improvement in progression-free survival (PFS) with a 72% risk reduction of progression or death (HR 0.28, p<0.001). Furthermore, the objective response rate was 76% for LORBRENA versus 58% for XALKORI. These findings will be reviewed under the FDA's Real-Time Oncology Review pilot program for potential first-line indication.

Pfizer and BioNTech have announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, has achieved a 95% efficacy rate in their Phase 3 trial, surpassing all primary endpoints. The study involved 43,661 participants, with the data showing efficacy consistent across demographics. The companies are preparing to submit a request for Emergency Use Authorization (EUA) from the FDA, following the achievement of the required safety milestone. They aim to produce up to 50 million doses in 2020 and up to 1.3 billion by the end of 2021.

Pfizer Inc. (NYSE: PFE) has completed the spin-off of its Upjohn Business, merging it with Mylan N.V. to create Viatris Inc. This all-stock Reverse Morris Trust transaction allows Pfizer shareholders to receive approximately 0.124079 shares of Viatris for each Pfizer share held. Post-transaction, Pfizer shareholders own about 57% of Viatris, with Mylan shareholders holding the remaining 43%. Pfizer has not updated its financial guidance, noting that contributions from Upjohn will be treated as discontinued operations.

Pfizer Inc. (NYSE: PFE) announced the publication of an analysis confirming that higher doses of VYNDAQEL (tafamidis meglumine) 80 mg and VYNDAMAX (tafamidis) 61 mg significantly improve long-term survival in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) compared to the lower dose of VYNDAQEL 20 mg. The analysis, detailed in the European Journal of Heart Failure, indicated a 30% reduction in mortality risk, increasing to 43% after adjusting for variables. These findings reinforce the use of VYNDAQEL 80 mg and VYNDAMAX 61 mg as optimal dosing for ATTR-CM patients.