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.
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.
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.
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.
Pfizer Inc. (NYSE:PFE) announced a peer-reviewed study showing that first-line therapy with IBRANCE® (palbociclib) plus letrozole significantly improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with HR+, HER2- metastatic breast cancer compared to letrozole alone. With a median follow-up of approximately two years, median rwPFS was 20.0 months for IBRANCE plus letrozole versus 11.9 months for letrozole alone, demonstrating a 42% reduction in progression risk. The OS rate was 78.3% in the IBRANCE group, indicating a clear benefit of using the combination therapy.
Pfizer Inc. (NYSE: PFE) has advanced to multiple ascending doses in a Phase 1 study of PF-07321332, a novel oral antiviral targeting SARS-CoV-2, after successfully completing single ascending dose testing. The study, conducted in the U.S., assesses safety, tolerability, and pharmacokinetics. This potential first-in-class therapy aims to provide oral treatment for COVID-19, complementing existing vaccines. Preclinical data supports its antiviral efficacy, with further findings to be presented at the Spring American Chemical Society meeting on April 6.
Pfizer invites investors and the public to its conference call on May 4, 2021, at 10 a.m. EDT. This call aims to discuss the First Quarter 2021 Performance Report. Interested participants can join via phone at (833) 711-4984 or (916) 900-3769, using the password 'First Quarter Earnings'. The report and webcast details are available at www.pfizer.com/investors. Pfizer is dedicated to improving global health through innovative medicines and vaccines, demonstrating its commitment for over 170 years.
The Israel Ministry of Health, Pfizer, and BioNTech announced significant findings from a real-world study showing a 97% effectiveness of the Pfizer-BioNTech COVID-19 Vaccine in preventing symptomatic COVID-19, severe cases, and deaths. This data, derived from health surveillance from January to March 2021, showcases the impact of Israel's vaccination efforts, particularly against the B.1.1.7 variant. Further, the vaccine demonstrated 94% effectiveness against asymptomatic infections, emphasizing its role in controlling the pandemic and supporting ongoing immunization campaigns globally.
Pfizer (NYSE: PFE) will host a webcast featuring CFO Frank D’Amelio at the Barclays Global Healthcare Conference on March 11, 2021, at 1:15 p.m. EST. Investors and the public can access the discussion via www.pfizer.com/investors. The archived recording will also be available on the same site after the event. Pfizer aims to enhance health care through innovative medicines and vaccines, maintaining a commitment to quality and safety in the biopharmaceutical industry for over 170 years.
The FDA has approved Pfizer's LORBRENA (lorlatinib) for first-line treatment of ALK-positive non-small cell lung cancer (NSCLC), expanding its indication for adults with metastatic disease. LORBRENA's transition from accelerated to full approval is based on the pivotal Phase 3 CROWN trial, which demonstrated a 72% reduction in progression or death compared to XALKORI. The drug targets common tumor mutations and is effective against brain metastases, presenting high response rates. Serious adverse events occurred in 34% of patients, with a 3.4% fatality rate.
Strata Oncology, Inc., a precision oncology firm, has launched the Strata PATH trial, a multi-drug and biomarker-driven clinical trial aimed at evaluating the effectiveness of FDA-approved therapies for specific cancer biomarkers. Pfizer (NYSE: PFE) will supply targeted drugs at no cost to participants. The trial is designed for patients with advanced solid tumors who have exhausted standard treatments. It utilizes Strata's comprehensive genomic profiling to match patients with investigational therapies, aiming to accelerate cancer treatment availability.