The HYPERION study will be stopped early due to positive efficacy data from across the sotatercept clinical program.
MSD’s sotatercept has become the first FDA-approved therapy for pulmonary arterial hypertension (PAH) that addresses the underlying mechanism behind the disease, rather than its symptoms.
The phase 3 HYPERION trial of Winrevair in adults with newly diagnosed pulmonary arterial hypertension functional class two ...
MSD has been granted a priority review by the FDA for its pulmonary arterial hypertension (PAH) candidate sotatercept, setting up a decision on the would-be blockbuster by 26th March next year.
Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIRâ„¢ (sotatercept-csrk) Early and Move to Final ...
After the FDA approved both combination macitentan/tadalafil (Opsynvi) and the biologic therapy sotatercept (Winrevair) for WHO group 1 pulmonary hypertension (PH, or PAH) over the course of one ...
Sotatercept was approved for use in combination with other medications to improve exercise capacity in adult PAH patients with moderate or marked limitations of physical activity, according to a ...
The Phase III HYPERION trial was stopped early after strong positive interim results from the ZENITH trial demonstrated the ...
Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and ...
The investigators noted that the HYPERION trial had lost clinical equipoise based on robust evidence of clinical benefit from other trials. A phase 3 trial evaluating sotatercept-csrk (Winrevair ...
World Health Organization **Dr. McLaughlin is a member of the adult sotatercept steering committee, an investigator in the ZENITH and HYPERION trials and a paid consultant to Merck. The HYPERION ...
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) versus placebo (both in combination with ...