Pfizer Stock Price, News & Analysis

Pfizer (PFE) reported strong financial results for full-year 2024, with revenues of $63.6 billion, showing 7% year-over-year operational growth. Excluding Paxlovid and Comirnaty contributions, revenues grew 12% operationally.

Fourth-quarter 2024 revenues reached $17.8 billion, with 21% operational growth excluding COVID products. The company reported full-year 2024 adjusted diluted EPS of $3.11 and fourth-quarter adjusted diluted EPS of $0.63.

Pfizer reaffirmed its 2025 financial guidance, projecting revenues between $61.0 to $64.0 billion and adjusted diluted EPS of $2.80 to $3.00. The company is on track to deliver overall net cost savings of approximately $4.5 billion by end of 2025 from its ongoing cost realignment program.

Pfizer (PFE) announced positive topline results from the Phase 3 BREAKWATER study of BRAFTOVI® combination therapy for metastatic colorectal cancer (mCRC) with BRAF V600E mutation. The study demonstrated statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy.

The BRAFTOVI combination regimen, which includes cetuximab and mFOLFOX6, received accelerated FDA approval in December 2024 for treatment-naïve patients based on improved objective response rate (ORR). The safety profile remained consistent with known profiles of each agent, with no new safety signals identified.

These results will be shared with the FDA to support potential conversion to full approval and with other global regulatory authorities for additional license applications.

Pfizer (PFE) will present significant advancements in genitourinary cancer treatments at the ASCO GU Cancers Symposium in San Francisco. The company will showcase more than 20 abstracts, including five oral presentations, focusing on prostate and bladder cancers.

Key highlights include detailed overall survival results from the Phase 3 TALAPRO-2 trial of TALZENNA® with XTANDI® in metastatic castration-resistant prostate cancer, which demonstrated statistically significant improvements. Updated analysis from the Phase 3 EV-302 trial shows sustained overall survival benefits of PADCEV® combined with pembrolizumab in advanced urothelial cancer.

The company will also present the first randomized progression-free survival data for mevrometostat with XTANDI in mCRPC. Pfizer's genitourinary portfolio includes seven approved medicines across bladder, prostate, and kidney cancers, with TALZENNA-XTANDI combination already approved in over 35 countries globally.

Pfizer (PFE) announced positive Phase 3 BREAKWATER trial results for BRAFTOVI® combination therapy in treating BRAF V600E-mutant metastatic colorectal cancer (mCRC). The trial showed a significantly higher objective response rate of 60.9% compared to 40% with standard chemotherapy.

Key findings include a median duration of response of 13.9 months for the BRAFTOVI combination versus 11.1 months for chemotherapy. Additionally, 22.4% of BRAFTOVI-treated patients maintained response for 12+ months, compared to 11.4% in the chemotherapy group.

While overall survival data is not yet mature, early trends favor the BRAFTOVI combination. The safety profile aligned with known profiles of individual components, with serious treatment-emergent adverse events occurring in 37.7% of BRAFTOVI combination patients versus 34.6% in the chemotherapy group. The FDA granted accelerated approval for this treatment in December 2024.

Pfizer (PFE) announced positive topline results from its Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody, combined with BCG therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint, showing significant improvement in event-free survival compared to BCG alone.

The treatment could potentially be the first PD-1 inhibitor approved in combination with BCG for this indication, representing the first major advancement in BCG-naïve, high-risk NMIBC treatment in over 30 years. Approximately 100,000 people globally are diagnosed with high-risk NMIBC annually, with 40-50% experiencing recurrent disease.

The safety profile of sasanlimab with BCG was consistent with known profiles of both treatments. Pfizer plans to submit the results to regulatory authorities and present them at upcoming medical conferences.

Pfizer Inc. (NYSE: PFE) has announced a public webcast featuring a discussion with Albert Bourla, Chairman and CEO, at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 9:45 a.m. PST.

The webcast will be accessible through www.pfizer.com/investors, with registration details available immediately. A transcript and replay will be posted within 24 hours and remain accessible for at least 90 days.

Pfizer, with a 175-year legacy, focuses on developing breakthrough therapies and vaccines that improve lives globally. The company emphasizes quality, safety, and value in healthcare product development, working across developed and emerging markets to advance wellness and treatments for major diseases. They collaborate with healthcare providers, governments, and communities to expand access to affordable healthcare worldwide.

Stuart Therapeutics has appointed Tracy Valorie and Jason Werner to its Board of Directors, expanding it to five members. They replace Robert O. Baratta, MD, who passed away in Q3, and Diane Black, RN, who resigned. Valorie, owner of TMV Associates , brings 30 years of pharmaceutical and biotech experience, including senior roles at Bausch + Lomb and Pfizer. Werner serves as Executive Chairman of Sightstream Biotherapeutics and has extensive experience in ophthalmology, including co-founding Eyevance Pharmaceuticals. Both appointments strengthen Stuart's leadership as it advances in ophthalmology therapeutics development and commercialization.

Pfizer (PFE) has received FDA accelerated approval for BRAFTOVI® combination with cetuximab and mFOLFOX6 as the first-line treatment for metastatic colorectal cancer with BRAF V600E mutation. The approval is based on the Phase 3 BREAKWATER trial results, which showed a 61% overall response rate compared to 40% in the control arm. The median duration of response was 13.9 months versus 11.1 months for the control group.

This marks the first and only combination regimen with targeted therapy approved for first-line use in this patient population. The safety profile was consistent with known profiles of each agent, with common adverse reactions including peripheral neuropathy, nausea, and fatigue. The approval was granted under FDA's Project FrontRunner initiative.

Pfizer (NYSE: PFE) has announced a conference call with investment analysts scheduled for 10:30 a.m. EST on Tuesday, February 4, 2025. The call will discuss Pfizer's Fourth Quarter and Full Year 2024 Performance Report, which will be released that morning.

Investors and the public can access the webcast through www.pfizer.com/investors. Participants can join via webcast or by phone using the following numbers: 800-456-4352 (US/Canada) or 785-424-1086 (International), with passcode '30674'. The webcast replay and transcript will be available within 24 hours after the call and accessible for at least 90 days on Pfizer's investor website.