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) announced that the FDA has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) targeting metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. The PDUFA goal date for a decision is set for Q4 2023. Currently, BRAFTOVI + MEKTOVI is approved for melanoma and colorectal cancer treatments. The sNDAs are based on the PHAROS trial results, which showed promising efficacy. However, the PR also mentions various risks and adverse effects associated with treatment, emphasizing the importance of ongoing monitoring.
org value="NYSE:PFE"Pfizer invites investors to join a conference call at 10 a.m. EDT on May 2, 2023 to discuss its First Quarter 2023 Performance Report. The call aims to provide insights into the company’s latest financial results. Interested parties can access the webcast and report via www.pfizer.com/investors, where registration details are also provided. Callers in the U.S. and Canada can dial 800-456-4352, while international participants should call 785-424-1086, using passcode “51512.” A transcript and replay will be available for 90 days after the call.
Pfizer and Astellas announced positive topline results from the Phase 3 EMBARK trial for XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) at high risk for biochemical recurrence. The trial met its primary endpoint, showing a statistically significant improvement in metastasis-free survival when comparing XTANDI plus leuprolide to placebo plus leuprolide. Additionally, XTANDI monotherapy also demonstrated significant benefits. Preliminary safety analyses revealed no new safety signals. Further details will be presented at future medical meetings, and discussions with the FDA for regulatory submission are anticipated.
Pfizer (NYSE: PFE) and Astellas Pharma have announced positive topline results from the Phase 3 EMBARK trial, evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) experiencing high-risk biochemical recurrence. The trial met its primary endpoint, demonstrating a significant improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide over placebo. Additionally, significant improvements were noted for patients on XTANDI monotherapy. A positive trend in overall survival was also observed and further data analysis is ongoing. Detailed results will be presented at a future medical meeting.
Pfizer announced that the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 in favor of PAXLOVID™ for treating mild-to-moderate COVID-19 in high-risk adults. This vote, while non-binding, will influence the FDA's decision by the target PDUFA action date in May 2023. PAXLOVID demonstrated an 86% reduction in hospitalization or death risk when taken early in symptomatic patients during clinical trials. Currently, over 10 million treatment courses are prescribed. If approved, PAXLOVID would be the first oral COVID-19 treatment sanctioned by the FDA. The EU has already granted marketing authorization for the drug.
Astellas Pharma announced positive results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study, involving 180 patients, achieved its primary endpoint by significantly delaying prostate-specific antigen (PSA) progression compared to placebo plus ADT. Key secondary endpoints were also met, indicating reduced radiographic progression-free survival (rPFS) and higher rates of undetectable PSA. These findings support XTANDI’s potential as a treatment option, pending regulatory approval from the China National Medical Products Administration (NMPA).
Pfizer has agreed to acquire Seagen for $229 per share, valuing the deal at approximately $43 billion. This acquisition positions Pfizer to enhance its oncology portfolio, expected to generate over $10 billion in risk-adjusted revenues by 2030. Seagen, known for its pioneering Antibody-Drug Conjugates (ADCs), anticipates $2.2 billion in revenue for 2023, reflecting a 12% year-on-year growth. The boards of both companies have unanimously approved the merger, which is projected to be neutral to slightly accretive to Pfizer's earnings per share within three to four years after closing.
Pfizer has announced a definitive agreement to acquire Seagen for $229 per share, totaling an enterprise value of approximately $43 billion. The merger aims to bolster Pfizer's oncology portfolio with Seagen's advanced Antibody-Drug Conjugates (ADCs) and development programs. Seagen is projected to generate over $10 billion in risk-adjusted revenues by 2030. The acquisition is expected to be financed primarily through $31 billion of long-term debt, with the deal anticipated to close in late 2023 or early 2024, subject to regulatory approvals.
Pfizer (NYSE: PFE) has announced FDA approval for ZAVZPRET (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for acute migraine treatment in adults. In pivotal Phase 3 studies, ZAVZPRET proved statistically superior to placebo in achieving pain freedom and alleviating bothersome symptoms at two hours post-dose. ZAVZPRET offers a rapid onset of action, with relief as early as 15 minutes. Targeted for July 2023 availability, this new treatment expands Pfizer's migraine portfolio, catering to the significant population of nearly 40 million migraine sufferers in the U.S.
Pfizer (NYSE: PFE) announced that the FDA’s Vaccines Advisory Committee voted 7-4 on both safety and effectiveness of its RSV vaccine candidate, PF-06928316 (RSVpreF). This decision supports the prevention of respiratory syncytial virus (RSV) in adults aged 60 and older. The recommendation is based on strong Phase 3 clinical trial evidence. The FDA's final decision is expected by May 2023. RSV poses a significant health threat, causing 60,000-160,000 hospitalizations and 6,000-13,000 deaths annually in older adults in the U.S., highlighting the need for effective vaccine options.