Scholar Rock Receives FDA Acceptance of Apitegromab BLA
"With the FDA's acceptance of our apitegromab BLA, we have achieved another critical milestone as we work with urgency to deliver on our mission to bring the world's first muscle-targeted treatment to the SMA community," said David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock. "We are grateful for the FDA's continued high level of engagement, and we are pleased that important progress continues to be made at both of our fill-finish facilities. Our U.S. commercial team stands ready to launch apitegromab on or at any time prior to the September 30th PDUFA date. Our balance sheet is strong, our clinical-stage pipeline continues to advance, and we are poised, now more than ever, to usher in the next phase of innovation for patients with SMA."
