Pfizer’s BREAKWATER Trial Yields PFS Boost, Q4 Revenue Tops Estimates by 6%
Pfizer’s BREAKWATER trial of BRAFTOVI plus cetuximab and FOLFIRI in BRAF V600E–mutant metastatic colorectal cancer showed a significant PFS boost and clinically meaningful OS gains, prompting an FDA submission. Q4 2025 revenue hit $17.6 billion (6% above) with EPS of $0.66 (16% above), but Daiwa and Bernstein assigned Hold ratings with $27–30 targets.
1. BREAKWATER Trial Results
Pfizer’s BREAKWATER trial tested BRAFTOVI with cetuximab and FOLFIRI in BRAF V600E–mutant metastatic colorectal cancer, showing a statistically significant improvement in progression-free survival and a secondary descriptive endpoint for overall survival that indicated clinically meaningful gains. Management plans to submit detailed data to the FDA for review, targeting regulatory engagement later this year.
2. Q4 2025 Financial Performance
In the fourth quarter of 2025, Pfizer reported revenue of $17.6 billion, exceeding consensus by 6%, and EPS of $0.66, beating estimates by 16%. The growth was driven by ongoing demand for its leading primary care and specialty medicines, offsetting declines in some established blockbusters.
3. Analyst Ratings and Outlook
Daiwa downgraded Pfizer from Buy to Hold with a $27 price target, while Bernstein maintained a Hold rating with a $30 target, noting that major R&D and oncology pipeline investments will determine 2026 outcomes. Investors will watch upcoming trial readouts and regulatory submissions as key catalysts for the stock.