Merck and Gilead discontinued a Phase 3 lung cancer trial due to lack of statistical significance, while Pfizer initiated a new Phase 1 trial and Roivant Sciences completed enrollment in its Phase 2 PHocus trial for pulmonary hypertension.
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
Two studies of older adults with type 2 diabetes linked diabetic retinal disease with higher dementia risk. DME and more severe diabetic retinopathy were associated with higher all-cause and vascular dementia risk, but not consistently with Alzheimer’s disease.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Relay Therapeutics reported full-year 2025 revenue of $15.36 million and a narrowed net loss of $276.48 million, while securing FDA Breakthrough Therapy designation for lead asset zovegalisib. The company filed a $96.18 million shelf registration.
