Pfizer Stock Price, News & Analysis

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 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 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 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 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 (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.

Pfizer Inc. (NYSE: PFE) will host a webcast discussion on March 7, 2023, at 10:30 a.m. EST, during the Cowen 43rd Annual Health Care Conference. Key speakers include Angela Hwang, Rodrigo Puga, and Annaliesa Anderson. Investors and the public can access the live webcast and registration details at www.pfizer.com/investors. A transcript and replay will be available within 24 hours after the event and will remain accessible for 90 days. Pfizer aims to leverage its science and resources to enhance patient life quality, focusing on innovative medicines and vaccines.