We recently published Lackluster Market? Not for These 10 Soaring Stocks. Scholar Rock Holding Corp. (NASDAQ:SRRK) is one of the best-performing stocks on Friday.
Scholar Rock soared by 24.41 percent on Friday to close at $37.41 apiece as investor sentiment was boosted by the progress of its drug candidate for spinal muscular atrophy (SMA).
In an updated report, Scholar Rock Holding Corp. (NASDAQ:SRRK) said that it completed “constructive and collaborative” in-person meeting with the Food and Drug Administration last Wednesday, November 12, for its biologics license application of apitegromab.
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Catalent Indiana, LLC, a unit of Novo Nordisk, joined Scholar Rock Holding Corp. (NASDAQ:SRRK) at the meeting and detailed progress in implementing the remediation plan, and affirmed that it expects the facility to be ready for reinspection by the end of this year.
Scholar Rock Holding Corp. (NASDAQ:SRRK) said BLA resubmission and US launch is anticipated 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.