Pfizer Stock Price, News & Analysis

Pfizer (NYSE: PFE) announced on October 31, 2025 that the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Act for Pfizer’s pending acquisition of Metsera (NASDAQ: MTSR).

The early termination satisfies the HSR Act regulatory review requirements for the proposed acquisition, which had a waiting-period expiry date of November 7, 2025. The transaction remains pending other closing conditions.

Pfizer (NYSE: PFE) and Astellas announced final Phase 3 EMBARK results showing that XTANDI plus leuprolide reduced the risk of death by 40.3% (HR 0.597; 95% CI 0.444-0.804; p=0.0006) versus leuprolide alone in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.

The 8-year overall survival was 78.9% with XTANDI plus leuprolide vs 69.5% with leuprolide. Median follow-up was ~94 months. XTANDI monotherapy showed a numerical but not statistically significant OS improvement (HR 0.83; p=0.1867). Safety was consistent with prior analyses; common adverse events included hot flashes, fatigue and gynecomastia.

Pfizer (NYSE: PFE) reported updated Phase 2 PHAROS results for BRAFTOVI + MEKTOVI in BRAF V600E-mutant metastatic non-small cell lung cancer. In treatment-naïve patients median overall survival was 47.6 months (95% CI 31.3, NE) after a median follow-up of 52.3 months; previously treated patients had median OS 22.7 months after 48.2 months follow-up. Four-year OS rates were 49% (treatment-naïve) and 31% (previously treated). The ORR was 75% (treatment-naïve) and 46% (previously treated). Safety was consistent with prior data; most common TRAEs ≥30% included nausea, diarrhea, fatigue and vomiting. Data presented at ESMO 2025 and published in Journal of Clinical Oncology.

Pfizer (NYSE: PFE) and Astellas announced positive Phase 3 EV-303 (KEYNOTE-905) results for PADCEV plus KEYTRUDA given before and after surgery in cisplatin-ineligible muscle-invasive bladder cancer.

Key results: EFS HR 0.40 (60% risk reduction; median EFS not reached vs 15.7 months), OS HR 0.50 (50% risk reduction; median OS not reached vs 41.7 months), pCR 57.1% vs 8.6%. Two-year EFS 74.7% vs 39.4%; two-year survival 79.7% vs 63.1%.

Safety consistent with known profile; grade ≥3 AEs higher in combination arm. Regulatory discussions planned.

ViiV Healthcare (PFE shareholder) reported 96-week PASO DOBLE results showing Dovato (dolutegravir/lamivudine) is non-inferior to Biktarvy (bictegravir/emtricitabine/TAF) in maintaining virological suppression in 553 virologically suppressed adults who switched regimens.

Key findings: risk difference for HIV-1 RNA ≥50 copies/mL was –0.7% (95% CI –2.1 to 0.7). Dovato had significantly less weight gain (mean difference 1.52kg, 95% CI 0.74–2.29) and fewer drug-related adverse events (7.6% vs 13.4%, p=0.025) through 96 weeks. No resistance was observed in cases of virological failure.

ViiV Healthcare (PFE) reported initial CLARITY Phase I crossover data showing single-dose cabotegravir (CAB LA) injections were more acceptable and better tolerated than lenacapavir (LEN) injections in 63 HIV‑negative adults (data presented 15 Oct 2025).

Key findings: 69% rated CAB LA “totally or very acceptable” vs 48% for LEN (post hoc p=0.019); 90% of participants and 86% of healthcare providers preferred CAB LA; LEN produced 4.4× more injection‑site reactions (538 vs 123).

Pfizer (NYSE: PFE) reported positive topline Phase 3 results from the HER2CLIMB-05 trial on October 14, 2025: first-line maintenance treatment adding TUKYSA (tucatinib) to trastuzumab plus pertuzumab met the primary endpoint with a statistically significant improvement in progression-free survival (PFS) by investigator assessment.

The company said the combination was tolerable with a safety profile consistent with known profiles of each therapy. Results will be presented at a future medical congress and discussed with regulatory authorities. TUKYSA remains approved in later-line settings but is not currently approved for first-line treatment in the United States.

Pfizer (NYSE: PFE) will present research across its infectious disease portfolio at IDWeek 2025 in Atlanta, October 19–22, 2025. Pfizer will feature data in 46 abstracts, including oral, late-breaking and poster sessions on COVID-19, RSV, pneumococcal disease, Lyme, meningococcal disease and other bacterial and viral infections. Presentations include real-world vaccine effectiveness analyses, clinical subanalyses and epidemiology studies across multiple programs.

The program lists session dates/times and directs readers to full prescribing information for referenced vaccines and therapeutics.