Pfizer Stock Price, News & Analysis

EMD Serono and Pfizer (NYSE: PFE) announced that the CHMP of the EMA adopted a positive opinion recommending BAVENCIO® (avelumab) for first-line maintenance treatment of advanced urothelial carcinoma (UC) patients who are progression-free after platinum-based chemotherapy. This decision, based on the Phase III JAVELIN Bladder 100 trial, is expected to be reviewed by the European Commission in early 2021. BAVENCIO is the first immunotherapy showing significant overall survival improvement in this setting. Approximately 200,000 bladder cancer cases are diagnosed yearly in Europe.

Pfizer Inc. (NYSE:PFE) has declared a 39-cent first-quarter 2021 dividend, payable on March 5, 2021, to shareholders on record as of January 29, 2021. This marks a 3% increase from the fourth-quarter 2020 dividend of 38 cents. The upcoming dividend will be the 329th consecutive quarterly dividend paid by Pfizer. The board's decision reflects confidence in Pfizer's business and its scientific pipeline. Following the merger of Upjohn and Mylan to form Viatris Inc., Pfizer's dividend will be adjusted to maintain shareholder value.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 4 in favor of granting Emergency Use Authorization (EUA) for Pfizer's and BioNTech's COVID-19 mRNA vaccine, BNT162b2. The committee's decision was based on robust data from a pivotal Phase 3 clinical trial, showing a vaccine efficacy rate of 95% after the second dose. The FDA will consider this recommendation before making a final decision on the EUA. All trial participants will be monitored for long-term safety. The companies remain ready to distribute the vaccine promptly if authorized.

Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) announced the publication of final efficacy results from their Phase 3 trial of the COVID-19 vaccine candidate BNT162b2. Involving 43,448 participants aged 16 and older, the trial demonstrated a 95% efficacy rate against COVID-19 with a favorable safety profile. The trial results showed that the vaccine was well-tolerated across diverse populations, including those with pre-existing conditions. The companies are pursuing regulatory submissions globally, having received emergency use authorizations in several countries.

Pfizer and BioNTech have released pivotal Phase 3 trial results for BNT162b2, their mRNA-based COVID-19 vaccine, published in the New England Journal of Medicine. The trial involved 43,448 participants and showed a remarkable 95% efficacy in preventing COVID-19 after a two-dose regimen. The vaccine was well-tolerated, with common side effects like fatigue and pain at the injection site. The companies are seeking Emergency Use Authorization from the FDA and have already received approvals in other countries. Ongoing monitoring for long-term safety and efficacy will continue for two more years.

Pfizer Inc. (NYSE:PFE) announced the FDA's acceptance for priority review of its Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC). This vaccine aims to prevent invasive diseases and pneumonia in adults aged 18 and older caused by multiple Streptococcus pneumoniae serotypes. The FDA decision is expected by June 2021. The 20vPnC vaccine shows promise in inducing immune memory and covers more serotypes than any currently licensed vaccine, potentially addressing a significant public health issue as pneumococcal pneumonia results in an estimated 500,000 deaths annually worldwide.

PostEra has formed a strategic partnership with Pfizer Inc. (NYSE: PFE), focusing on enhancing small molecule drug discovery through advanced machine learning technologies. This multi-year collaboration aims to develop a generative chemistry platform to optimize novel molecular structures.

PostEra will receive upfront payments and additional funding as the project progresses while retaining rights to all developed algorithms. Both companies will combine Pfizer's extensive data and PostEra's technological capabilities to address challenges in preclinical drug discovery.

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.