Phase 3
Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.
While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
With Phase 3 data in hand, Intellia Therapeutics is seeking approval for its in vivo CRISPR gene editing therapy for hereditary angioedema.
A triplet regimen comprising Merck’s Welireg and PD-1 blockbuster Keytruda and Eisai’s Lenvima flopped in a Phase 3 renal cell carcinoma trial.
The Phase 3 failure has prompted Gilead Sciences and Arcus Biosciences to terminate a mid-stage study of their TIGIT asset in lung cancer.
Novo Nordisk’s etavopivat elicited a 27% drop in vaso-occlusive crises and 48.7% hemoglobin response after 24 weeks, creating “separation amongst PK class candidates,” Truist analysts said on Monday. Novo plans to seek FDA approval in the back half of 2026.
In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings.
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.
Sales of Amgen’s thyroid eye disease drug Tepezza have slowed, dipping 1% to $457 million in the fourth quarter of 2025.
Presentations at the 2026 meeting of the American Academy of Dermatology not only demonstrate the therapeutic potential of next-generation skin drugs but also shed light on how they might fare on the market.
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