Scholar Rock (SRRK) Soars 29% as Drug Candidate Progresses

We recently published 10 Market Movers That Made Millionaires in a Week. Scholar Rock Holding Corp. (NASDAQ:SRRK) is one of the best-performing stocks of the past trading week.

Scholar Rock saw its share prices climb by 29.2 percent on week-on-week as investors took heart from positive developments for its drug candidate for spinal muscular atrophy (SMA).

In an announcement last week, Scholar Rock Holding Corp. (NASDAQ:SRRK) said that it sat down with the Food and Drug Administration and third-party manufacturing contractor, Catalent Indiana, last Wednesday to discuss its biologics license application for apitegromab.

This followed the FDA’s rejection of its application last September following inspection issues at the manufacturing facility.

Catalent, for its part, detailed progress in implementing the remediation plan, and affirmed that the facility would be ready for reinspection by the end of this year.

Scholar Rock Holding Corp. (NASDAQ:SRRK) said it plans to resubmit a BLA application, with official launch targeted by next year.

Additionally, it said that it targets to secure the approval of the European Medicines Agency (EMA) to sell apitegromab to Europe by mid 2026.

Also on Friday, the company announced the results of its earnings performance in the third quarter of the year, where it widened its net loss by 58 percent to $102 million from $64.5 million in the same period last year, pulled down by a 60 percent higher operating loss of $103.5 million versus $64.78 million year-on-year.

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Disclosure: None. This article is originally published at Insider Monkey.