Servier will acquire Edgewise Therapeutics' muscular dystrophy business, including the drug sevasemten, for up to $2.65 billion. Sevasemten recently faced an FDA rejection for accelerated approval in Becker muscular dystrophy but is advancing to a Phase 3 trial in 2026. The drug has received multiple FDA and EMA designations for both Becker and Duchenne muscular dystrophy.
Two studies found cardiac MRI-derived biomarkers may improve heart failure risk assessment. Epicardial adipose tissue index was linked to HFpEF risk, while imaging-derived SvO2 predicted hospitalization and death.
Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.
A study finds nearly half of melanoma patients receiving BRAF or MEK inhibitors develop hypertension or cardiac dysfunction. Moderate to severe cardiac issues appear within 4 weeks and only in patients with medium or higher baseline risk. Higher baseline NT-proBNP levels are associated with increased cardiac dysfunction risk.
Gossamer Bio's seralutinib narrowly missed its primary endpoint in the Phase 3 PROSERA study for pulmonary arterial hypertension, achieving a p-value of 0.0320 versus the prespecified threshold of 0.025, though showing stronger results in intermediate- and high-risk patients.
Prothena reported Q4 2025 adjusted loss of 45 cents per share, meeting estimates, while ending the year with $308.4 million in cash. Roche and Novo Nordisk advanced partnered programs prasinezumab and coramitug into Phase III trials.
