The seventh annual Calves to Cure DMD charity cattle auction raised funds to help fund research for Duchenne muscular dystrophy.
The complete response letter was issued by the FDA during a routine inspection of a third-party fill-finish facility, not because of an issue with apitegromab.
The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.