Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
Ad hoc announcement pursuant to Art. 53 LR Food and Drug Administration (FDA) approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in children and adults aged 2 years and olderU.S. license holder Catalyst Pharmaceuticals plans for commercial launch in Q1-2024FDA approval triggers USD 36 million payment obligation from Catalyst to Santhera, of which USD 26 million will be used to cover Santhera’s third-party milestone obligationsFollowing the recent positive CHMP