Scholar Rock: FDA Grants Fast Track And Orphan Drug Designations To Apitegromab

Scholar Rock (SRRK) said the FDA granted Fast Track and Orphan Drug designations for apitegromab in facioscapulohumeral muscular dystrophy, a meaningful regulatory milestone. The company also reported that participant dosing is underway in the Phase (study), supporting near-term clinical progression. Overall, the news increases the probability of development success and can be supportive for sentiment around the program.