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. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
Pfizer Inc. (NYSE: PFE) has acquired Amplyx Pharmaceuticals, which specializes in therapies for life-threatening diseases in immunocompromised patients. The key focus of this acquisition is Amplyx's lead compound, Fosmanogepix (APX001), designed to treat invasive fungal infections. With over 1.5 million global cases annually and a high mortality rate, Fosmanogepix targets drug-resistant fungal strains, introducing a potentially novel therapeutic class. This acquisition follows Pfizer’s previous investment in Amplyx, aiming to enhance its anti-infective portfolio.
Pfizer (NYSE: PFE) has declared a 39-cent dividend for Q2 2021, payable on June 4, 2021, to shareholders on record by May 7, 2021. This marks the 330th consecutive quarterly dividend, highlighting the company's commitment to returning capital to investors. Despite Viatris' upcoming dividend declaration, Pfizer maintains its dividend rate, benefiting shareholders holding shares in both companies. CEO Albert Bourla emphasized that strong financial performance underpins their ability to deliver value to patients and shareholders alike.
Pfizer (NYSE: PFE) invites shareholders to its virtual-only 2021 Annual Meeting on April 22 at 9:00 a.m. EDT. The decision for a virtual format was made in light of ongoing COVID-19 health concerns. Shareholders will have equivalent rights to participate and can log in starting at 8:45 a.m. using their control number. Questions can be submitted in advance by 5:00 p.m. EDT on April 21. A replay of the meeting will be available for one year. For more info, visit www.meetingcenter.io/274898886.
Pfizer Inc. (NYSE: PFE) announced an extension of the FDA's priority review period for the New Drug Application (NDA) of abrocitinib, aimed at treating moderate to severe atopic dermatitis in adults and adolescents. The Prescription Drug User Fee Act (PDUFA) goal date is now set for early Q3 2021, extended by three months. Additionally, the FDA has also extended the review period for the Supplemental New Drug Applications (sNDAs) for XELJANZ® / XELJANZ® XR (tofacitinib) for active ankylosing spondylitis by three months, with the same goal date in early Q3 2021.
Pfizer Inc. (NYSE: PFE) will host a live video webcast on April 9, 2021, at 10 a.m. EDT, featuring updates on its Oncology pipeline, including therapies like LORBRENA® for lung cancer and elranatamab for multiple myeloma. Investors can access the webcast through Pfizer's investor relations website. The session will also include a live Q&A. Pfizer emphasizes its commitment to advancing healthcare and the importance of scientific innovation in developing effective therapies for serious diseases.
Pfizer and BioNTech released updated topline results from their pivotal Phase 3 study on the BNT162b2 COVID-19 vaccine, reporting a 91.3% efficacy rate in preventing symptomatic COVID-19. The vaccine showed 100% effectiveness against severe disease according to the CDC and 95.3% against severe COVID-19 per the FDA. Safety data indicated a favorable profile from over 12,000 participants monitored for at least six months post-vaccination. These results bolster plans for a Biologics License Application to the FDA.
Pfizer (PFE) and BioNTech (BNTX) announced the successful results of a Phase 3 trial for their COVID-19 vaccine BNT162b2, showing 100% efficacy in adolescents aged 12 to 15. The trial, involving 2,260 participants, indicated no COVID-19 cases in the vaccinated group compared to 18 in the placebo group. The companies intend to submit these findings for Emergency Use Authorization (EUA) modification in the US and similar requests globally. They are also advancing studies in younger children, with the goal of public vaccination before the next school year.
Astellas Pharma announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for an additional indication of XTANDI (enzalutamide) for men with metastatic hormone-sensitive prostate cancer (mHSPC). Currently, mHSPC has a median survival of 3-4 years, highlighting the necessity for new treatment options. If approved by the European Commission, XTANDI will be the only oral treatment for three types of advanced prostate cancer. The recommendation is based on the Phase 3 ARCHES trial, showing a 61% reduction in the risk of progression or death.
Astellas Pharma has received a positive opinion from the European Medicines Agency's CHMP for XTANDI (enzalutamide) to treat metastatic hormone-sensitive prostate cancer (mHSPC). This oral therapy addresses a significant unmet medical need, as mHSPC has a median survival of about 3-4 years. If approved by the European Commission, enzalutamide will be the only oral treatment for three types of advanced prostate cancer. The decision is based on favorable results from the Phase 3 ARCHES trial, where enzalutamide plus androgen deprivation therapy significantly reduced the risk of disease progression.
Pfizer (NYSE:PFE) and Eli Lilly (NYSE:LLY) faced a setback as the FDA Joint Advisory Committee voted 1 in favor and 19 against their proposed risk evaluation for tanezumab, an investigational drug for moderate-to-severe osteoarthritis pain. Tanezumab, which is being considered to help patients who have exhausted other therapies, uses a novel mechanism targeting nerve growth factor. Both companies express disappointment but maintain confidence in tanezumab's potential benefits. The advisory vote is non-binding, and discussions will continue as the FDA reviews the ongoing Biologics License Application.