Pfizer Stock Price, News & Analysis

Pfizer (PFE) announced groundbreaking results from its Phase 3 BREAKWATER trial for BRAFTOVI combination therapy in treating BRAF V600E-mutant metastatic colorectal cancer. The treatment demonstrated remarkable efficacy, reducing death risk by 51% compared to standard care, with median overall survival of 30.3 months versus 15.1 months. The therapy also showed a 47% reduction in disease progression risk, with median progression-free survival of 12.8 months compared to 7.1 months. The objective response rate was significantly higher at 65.7% versus 37.4% for standard treatment. The FDA granted accelerated approval in December 2024, with potential full approval in 2025. The safety profile remained consistent with known profiles, with common side effects including nausea, anemia, and diarrhea. This breakthrough represents the first promising survival outcomes for BRAF-mutant metastatic colorectal cancer in first-line treatment.

A significant legal challenge faces Pfizer (NYSE:PFE) as a Case Management Conference is scheduled for May 30, 2025, regarding the Depo-Provera multidistrict litigation. The case involves approximately 400 lawsuits following a March 2024 British Medical Journal study showing women using Depo-Provera for over a year were 5.6 times more likely to develop intracranial meningioma. Law firm Levin Papantonio, which has secured over $80 billion in verdicts, is leading the litigation. The lawsuits allege Pfizer knew about the brain tumor risks but failed to warn U.S. consumers, despite issuing warnings in Canada (2015), UK/Europe (2024), and South Africa (2025). Studies indicate that among Depo-Provera users, approximately 2% develop brain tumors, compared to the normal rate of 40 per 10,000 women. The contraceptive, used by an estimated 74 million women globally, has a controversial history, including three FDA rejections between 1978-1992 before final approval.

Astellas and Pfizer announced significant five-year follow-up results from the Phase 3 ARCHES trial for XTANDI™ (enzalutamide) in treating metastatic hormone-sensitive prostate cancer (mHSPC). The study showed that XTANDI plus androgen deprivation therapy (ADT) reduced death risk by 30% compared to placebo plus ADT. After 61.4 months median follow-up, XTANDI plus ADT demonstrated 66% survival probability at five years versus 53% with placebo plus ADT. The drug showed particular effectiveness in high-volume disease patients, with a 36-month improvement in median overall survival. Additionally, eight-year data from the ENZAMET study revealed that XTANDI plus testosterone suppression achieved median overall survival of 8.0 years compared to 5.8 years in the control group. XTANDI has treated over one million patients globally since its 2012 approval.

Pfizer (NYSE: PFE) has secured an exclusive global licensing agreement with Chinese biotech 3SBio for SSGJ-707, a promising bispecific antibody targeting PD-1 and VEGF, excluding China market. The deal includes an upfront payment of $1.25 billion plus potential milestone payments up to $4.8 billion and tiered double-digit royalties. SSGJ-707 is currently in clinical trials for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors in China, with Phase 3 studies planned for 2025. The agreement includes Pfizer's option for China commercialization rights and a $100 million equity investment in 3SBio. Manufacturing will be conducted at Pfizer's facilities in North Carolina and Kansas. The transaction is expected to close in Q3 2025, subject to regulatory approvals and shareholder approval.

Astellas Pharma will present 16 abstracts at the 2025 ASCO Annual Meeting (May 30 - June 3), showcasing new data across its cancer therapies. Key highlights include:

For XTANDI (enzalutamide): New post hoc analyses of long-term overall survival data, including the ARCHES five-year follow-up OS analysis in metastatic hormone-sensitive prostate cancer patients. The ENZAMET trial will present eight-year data comparing enzalutamide vs non-steroidal anti-androgen.

For PADCEV (enfortumab vedotin): Two analyses from the phase 3 EV-302 study in previously untreated locally advanced or metastatic urothelial carcinoma, featuring an exploratory analysis of responders and long-term subgroup analysis.

The presentations emphasize Astellas' focus on long-term overall survival data and clinical outcomes that matter to patients in advanced prostate and bladder cancers.

Pfizer reported solid Q1 2025 financial results with revenues of $13.7 billion, showing an 8% decrease from Q1 2024. The company achieved Adjusted Diluted EPS of $0.92, marking a 12% increase year-over-year.

Key highlights include:

• On track to exceed $4.5 billion in net cost savings by end of 2025
• Additional expected savings of $1.2 billion through 2027
• R&D reorganization to deliver $500 million in savings by 2026
• Manufacturing optimization to save $1.5 billion by 2027

The company reaffirmed its 2025 guidance with expected revenues of $61.0 to $64.0 billion and Adjusted Diluted EPS of $2.80 to $3.00. Notable product performance included growth in Vyndaqel family (+33%) and Comirnaty (+62%), while Paxlovid saw a 75% decline. The company maintained strong capital allocation, including $2.4 billion in cash dividends to shareholders.

Pfizer (NYSE: PFE) announced breakthrough results from its Phase 3 CREST trial for sasanlimab, an investigational PD-1 inhibitor, combined with BCG therapy for bladder cancer treatment. The study demonstrated a 32% reduction in disease-related events risk compared to standard BCG treatment alone.

The trial met its primary endpoint with statistically significant improvement in event-free survival (EFS). The probability of being event-free at 36 months was 82.1% with the combination therapy versus 74.8% with BCG alone. For patients with CIS who achieved complete response, the probability of maintaining response at 36 months was 91.7% with combination therapy compared to 67.7% with BCG alone.

This represents the first potential treatment advancement for BCG-naïve, high-risk non-muscle invasive bladder cancer in over 30 years. The results are particularly significant as bladder cancer is the ninth most common cancer worldwide, with NMIBC representing approximately 75% of cases. The safety profile aligned with known BCG and PD-1 inhibitor characteristics.

Guardant Health (Nasdaq: GH) has announced a strategic collaboration with Pfizer (NYSE: PFE) to advance cancer therapy development using the Guardant Infinity™ smart liquid biopsy platform. The multi-year global partnership will:

• Implement Guardant's liquid biopsy tests in Pfizer's global clinical studies
• Assess circulating tumor DNA (ctDNA) as a surrogate endpoint for therapy response monitoring
• Evaluate blood-based epigenomic analyses

The agreement includes access to Guardant's liquid biopsy tests in China for Pfizer's global clinical trials with Chinese cohorts, building on Guardant's existing partnership with Adicon Holdings announced in July 2022.

Pfizer (NYSE: PFE) has announced its second-quarter 2025 dividend declaration. The company's board of directors has approved a quarterly cash dividend of $0.43 per share, which will be paid on June 13, 2025, to shareholders of record as of May 9, 2025. This marks Pfizer's 346th consecutive quarterly dividend payment, highlighting the company's long-standing commitment to shareholder returns.