Scholar Rock Holding Corp. (NASDAQ:SRRK) saw its share prices soar by 29.2 percent last week due to positive developments for its spinal muscular atrophy drug candidate. The company plans to resubmit a BLA application with the FDA for apitegromab, targeting an official launch next year. Scholar Rock aims to secure EMA approval to sell apitegromab in Europe by mid-2026.

The FDA rejected Scholar Rock’s BLA application last September, citing inspection issues at the manufacturing facility. Catalent, the third-party manufacturing contractor, detailed progress in implementing a remediation plan and expects the facility to be ready for reinspection by year-end. Scholar Rock plans to resubmit the BLA application with hopes of securing approval for apitegromab.

In the third quarter of the year, Scholar Rock reported a widened net loss of $102 million, a 58 percent increase from the same period last year. Operating losses also increased by 60 percent to $103.5 million. Despite the promising performance of SRRK, some believe that other AI stocks offer greater returns with limited downside risk.

Read more at Yahoo Finance: Scholar Rock (SRRK) Soars 29% as Drug Candidate Progresses