Pfizer (PFE)

Pfizer Inc. (NYSE: PFE) and Astellas Pharma U.S. Inc. (Head of Commercial: Mike Petroutsas, "Astellas") today announced final overall survival (OS) results from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For the key secondary endpoint of OS, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone (Hazard Ratio [HR]: 0.597; 95% Confidence Interval [CI], 0.444-0.804; p=0.0006), making this the first and only androgen receptor inhibitor-based regimen to demonstrate an OS benefit in nmHSPC with high-risk BCR.1 The 8-year overall survival was 78.9% (95% CI, 73.9% to 83.1%) among patients receiving XTANDI plus leuprolide and 69.5% (95% CI, 64.0% to 74.3%) among patients taking leuprolide alone.1 A numerical improvement in OS with XTANDI as monotherapy compared to leuprolide alone (HR: 0.83 [95% CI, 0.63-1.095; p=0.1867) did not reach statistical significance.1 These data are being presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany and have been simultaneously published in The New England Journal of Medicine.

Pfizer Inc. (NYSE: PFE) today announced updated follow-up results from the single-arm Phase 2 PHAROS trial evaluating BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adults with metastatic non-small cell lung cancer (mNSCLC) with a BRAF V600E mutation. In treatment-naïve patients, the median overall survival (OS) was 47.6 months (95% confidence interval [CI], 31.3, not estimable) after a median follow-up of 52.3 months. In previously treated patients, the median OS was 22.7 months (95% CI, 14.1, 32.6), after a median follow-up of 48.2 months. The four-year OS rates were 49% (95% CI, 35, 62) and 31% (95% CI, 16, 47) for treatment-naïve and previously treated patients, respectively. These data, from pre-specified secondary trial endpoints, will be presented today in an oral presentation (1849MO) at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, and have been simultaneously published in the Journal of Clinical Oncology.

Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). HER2CLIMB-05 is evaluating TUKYSA versus placebo, both in combination with first-line standard-of-care maintenance therapy (trastuzumab plus pertuzumab) following chemotherapy-based induction. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in the TUKYSA arm versus the placebo arm. Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the established safety profiles of each individual therapy.

Pfizer Inc. (NYSE: PFE, “Pfizer”) will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025. Data in 46 abstracts from company- and collaborator-led studies will showcase significant advancements in preventing and treating infectious diseases.

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.43 fourth-quarter 2025 dividend on the company’s common stock, payable December 1, 2025, to holders of the Common Stock of record at the close of business on November 7, 2025. The fourth-quarter 2025 cash dividend will be the 348th consecutive quarterly dividend paid by Pfizer.

BALA CYNWYD, Pa., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky (jbrodsky@brodskysmith.com) or Marc Ackerman (mackerman@brodskysmith.com) at 855-576-4847. There is no cost or financial obligation to you.

Pfizer Inc. (NYSE: PFE) today announced a historic agreement with the Trump Administration that will ensure U.S. patients pay lower prices for their prescription medicines while strengthening America’s role as the global leader in biopharmaceutical innovation.

BALA CYNWYD, Pa., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky (jbrodsky@brodskysmith.com) or Marc Ackerman (mackerman@brodskysmith.com) at 855-576-4847. There is no cost or financial obligation to you.

A hearing in the Depo-Provera legal action against Pfizer Inc. (NYSE:PFE) will take place on Monday, 29 September at 9:00am CT in the United States Courthouse in Pensacola, Florida. The hearing will address oral arguments from the plaintiffs and defendants concerning the issue of pre-emption. The pre-emption defence is common in drug litigation. It involves the drug manufacturer arguing that they cannot be sued for failure to warn under state law, because changes to a drug warning label are governed by federal law and the FDA. The pre-emption defence asserts that the FDA rejected its request to add a tumour warning to the drug’s label, pre-empting any state law claims that it failed to warn consumers and physicians. The plaintiffs argue that Pfizer’s pre-emption defence fails because the company’s request to the FDA was too broad, because it grouped Depo-Provera with other lower dose hormonal contraceptives, and this led to the FDA’s decision not to approve a tumour warning on the drug’s label in the USA. Also, according to a UN 2022 family planning report, 247 million worldwide are on hormonal contraceptives5,6.

Pfizer Inc. (NYSE: PFE) will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer’s core scientific modalities and key tumor areas.

Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EST on Tuesday, November 4, 2025. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2025 Performance Report, to be issued that morning.

BALA CYNWYD, Pa., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky (jbrodsky@brodskysmith.com) or Marc Ackerman (mackerman@brodskysmith.com) at 855-576-4847. There is no cost or financial obligation to you.

Pfizer Inc. (NYSE: PFE) and Metsera, Inc. (NASDAQ: MTSR) today announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a portfolio of differentiated oral and injectable incretin, non-incretin and combination therapy candidates with potential best-in-class efficacy and safety profiles. The Boards of Directors of both Metsera and Pfizer have unanimously approved the transaction.

Arvinas and Pfizer plan to jointly select third party for the out-licensing and commercialization of vepdegestrant

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY® (COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination. These clinical findings reinforce pre-clinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the LP.8.1-adapted COVID-19 vaccine, which demonstrated improved immune responses against multiple circulating SARS-CoV-2 sublineages.

Unprecedented Student Growth including thousands of refugees

SAN FRANCISCO, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced a new clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) in metastatic breast cancer. The companies will evaluate in a Phase 1b/2 study the safety and combinability of palazestrant plus atirmociclib, Pfizer’s investigational, highly selective-CDK4 inhibitor, in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2

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The crucial role of vaccines in protecting public health couldn't have been clearer than with the recent coronavirus pandemic. COVID-19 vaccines were instrumental in helping to reduce the spread of the virus, propelling vaccines to the top ten therapy category by sales as of 2023.

The obesity treatment market is exploding, with Goldman Sachs projecting it to reach $130 billion by 2030. Driven by rising global obesity rates—now at 42% of U.S. adults, per the CDC—the sector has become a magnet for investors seeking exposure to transformative medicine.

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Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). The EV-303 study is evaluating PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy.