Technology

The FDA's PDUFA target date for a Winrevair label update covering newly diagnosed pulmonary arterial hypertension patients passed on September 21, 2026, with no confirmed approval, extension, or rejection found in Merck or FDA records as of 4:04 a.m. EDT that morning. The proposed update is based on the Phase 3 HYPERION trial, in which sotatercept reduced clinical-worsening events by 76% compared to placebo in 320 patients diagnosed within one year. A separate August 12 label amendment addressing long-term safety data is distinct from this pending HYPERION decision and should not be read as its resolution.

Avacta's preliminary Phase 1a data for its peptide-drug conjugate AVA6103 show low rates of hematologic toxicity in 19 patients, but no clinical efficacy results have been reported and the company's central claim of a tumor drug reservoir remains unconfirmed by biopsy. The full adverse-event dataset, including grades, dose-limiting toxicities, and serious adverse events, has not been disclosed. Independent confirmation of the mechanism and first efficacy data are not expected until H1 2027.