Cardiovascular disease
Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher.
While tonlamarsen missed one of two co-primary endpoints, Kardigan says the drug has shown a clinically meaningful effect on blood pressure, supporting advancement into Phase 2b.
The lack of a dose-response effect could be due to the high number of dropouts in the higher-dose Winrevair arm and the relatively small study population, a discussant for Merck explained.
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Gossamer Bio reported last month that its only late-stage candidate failed a Phase 3 study in pulmonary arterial hypertension, casting doubt on the asset’s future prospects.
The alliance, which pairs Tenaya’s modality agnostic target identification and validation capabilities with Alnylam’s deep experience in RNA interference therapeutics, comes during a period of resurgence for the cardiovascular space.
The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.
Following a disappointing Phase 3 performance and given Gossamer Bio’s balance sheet, seralutinib’s path to the market for pulmonary arterial hypertension has become unclear, according to analysts at Guggenheim Partners.
Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Novartis and Unnatural Products did not specify which disease targets they’re going after, only noting that the latter’s macrocyclic platform can generate potentially next-generation therapies that could apply to cardiovascular conditions.
PRESS RELEASES