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 (PFE) received FDA approval for its TUKYSA combination as front-line maintenance treatment for adults with HER2-positive advanced breast cancer. The approval covers TUKYSA with trastuzumab and pertuzumab after induction treatment for unresectable locally advanced or metastatic disease, providing a chemotherapy-free maintenance option.
In the Phase 3 HER2CLIMB-05 trial, median investigator-assessed progression-free survival—the time without cancer worsening or death—was 24.9 months versus 16.3 months with placebo, both alongside trastuzumab and pertuzumab. The primary analysis showed a 35.9% reduction in progression or death risk. Liver toxicity was more severe than TUKYSA's known safety profile. Serious adverse reactions occurred in 17% of TUKYSA recipients, including one fatal drug-induced liver injury. TUKYSA carries a boxed warning for severe and fatal liver toxicity, particularly after restarting treatment.
Astellas Pharma (TSE: 4503) will present 21 oncology abstracts at ESMO 2026, scheduled for October 23–27 in Madrid, Spain. Presentations include long-term follow-up of enfortumab vedotin with or without pembrolizumab in advanced bladder cancer, alongside subgroup analyses and bladder-preservation trials in progress. Zolbetuximab research covers CLDN18.2, a protein used to identify patients for treatment, and real-world use in gastric and gastroesophageal junction cancers.
The program also includes enzalutamide research in prostate cancer and ongoing investigational studies: Phase 3 setidegrasib trials in pancreatic and non-small cell lung cancers, a Phase 1 ASP5834 trial and a Phase 1b/2 ASP546C trial.
Pfizer (NYSE: PFE) declared a fourth-quarter 2026 cash dividend of $0.43 per common share, payable December 7, 2026.
Shareholders of record at the close of business on November 6, 2026 qualify for the payment. Pfizer said its capital allocation strategy includes maintaining the dividend and growing it over the longer term.
Pfizer (PFE) presented two Phase 3 trials showing LITFULO improved facial and total body repigmentation versus placebo in nonsegmental vitiligo. At Week 52, at least 75% improvement in facial pigmentation occurred in 21.86% versus 2.40% with 100 mg in TRANQUILLO 2 and 12.47% versus 2.48% with 50 mg in TRANQUILLO. At least 50% improvement in total body pigmentation occurred in 13.02% versus 2.40% and 8.98% versus 1.98%, respectively.
Improvements appeared by Week 24 and increased through Week 52; patient-reported disease severity also improved. No new safety signals emerged, although adverse events occurred in 67.7% versus 62.0% in TRANQUILLO 2 and 81.0% versus 77.1% in TRANQUILLO. The trials evaluated 2,174 patients. Pfizer intends to submit the data globally, including to the FDA and EMA, for a potential adult vitiligo indication.
Pfizer (NYSE: PFE) reported that tilrekimig met its Phase 2 primary endpoint in adults with moderate-to-severe atopic dermatitis across all evaluated doses. At Week 16, EASI-75, a reduction of at least 75% in eczema severity and extent, occurred in 62.5% receiving 450 mg every two weeks versus 19.9% on placebo. Monthly doses of 400 mg, 200 mg and 50 mg achieved rates of 58.5%, 61.0% and 47.8%, respectively, versus 9.1% on placebo. All comparisons were statistically significant.
Clear or almost-clear skin responses also improved; exploratory itch results favored the 400 mg and 200 mg monthly doses. No serious adverse events related to tilrekimig occurred in either stage. Adverse event rates were higher than placebo in Stage 1 and lower in Stage 2. Patients have been dosed in two Phase 3 dermatitis studies and one asthma study; a Phase 2b/3 COPD study is ongoing.
Pfizer (PFE) will present 45 oncology research abstracts at the ESMO Congress in Madrid, running October 23–27, 2026. The program includes 11 oral presentations and covers breast, lung and genitourinary cancers.
Planned presentations include Phase 2 results for atirmociclib in advanced breast cancer and Phase 3 survival results for investigational sigvotatug vedotin in previously treated lung cancer. Pfizer will also present updated analyses of PADCEV-based treatment and TALAPRO-3 patient-reported outcomes and safety data. A supplemental application for TALZENNA plus XTANDI in metastatic castration-sensitive prostate cancer remains under FDA Priority Review.
Pfizer (PFE) will host a webcasted conference call with investment analysts at 10:00 a.m. EST on Tuesday, November 3, 2026, to discuss its Third Quarter 2026 Performance Report, which is scheduled to be issued that morning.
Investors and the public can access the live webcast and the Performance Report at www.pfizer.com/investors, where registration instructions are available beginning September 22, 2026. Participants are advised to register in advance. The call can also be joined by phone by dialing 800-456-4352 in the U.S. and Canada or 785-424-1086 outside these regions, using passcode 11974. A transcript and replay of the webcast will be posted on the investor website within 24 hours after the call and remain accessible for at least 90 days.
Pfizer (PFE) will host a webcast of a discussion with Chief International Commercial Officer and Executive Vice President Alexandre de Germay at the J.P. Morgan U.S. All Stars 2026 Conference on Tuesday, September 22, 2026, at 11:50 a.m. BST.
Investors and the public can access the live audio via the www.pfizer.com/investors website, where registration and access details are available beginning September 15, 2026. A transcript and replay of the webcast will be posted on the same site within 24 hours after the live discussion and will remain accessible for at least 90 days. Pfizer notes that the webcast may contain forward-looking statements subject to substantial risks and uncertainties, as described in its SEC filings.
Pfizer (PFE) will webcast a discussion with Chairman and CEO Albert Bourla at the Morgan Stanley 24th Annual Global Healthcare Conference on Monday, September 14, 2026, at 10:45 a.m. EDT.
The live audio will be accessible through the investor section of Pfizer’s website at www.pfizer.com/investors, where access and registration details are available starting today. A transcript and replay of the webcast will be posted on the same site within 24 hours after the event and remain available for at least 90 days. Pfizer notes the webcast may contain forward-looking statements subject to risks described in its SEC filings.
Pfizer (NYSE:PFE) and Valneva (Nasdaq:VALN; Euronext Paris:VLA) announced that the European Medicines Agency has validated the Marketing Authorization Application for PF‑07307405, their 6‑valent OspA‑based Lyme disease vaccine candidate, and will now begin its formal assessment. The filing is supported by Phase 3 VALOR data showing more than 70% efficacy in preventing Lyme disease in participants aged five years and older, with the vaccine reported as well tolerated and with no safety concerns identified. According to the companies, PF‑07307405 targets six Borrelia OspA serotypes prevalent in North America and Europe, and is the most clinically advanced Lyme disease vaccine candidate, with two pivotal Phase 3 trials completed.