Scholar Rock Holding Inc. (NASDAQ:SRRK) stock is falling on Monday with a session volume of 8.19 million versus the average volume of 2.08 million, as per data from Benzinga Pro.
In a press release on Monday, the company stated that on Friday, October 10, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Catalent Indiana, LLC, a subsidiary of Novo Nordisk A/S (NYSE:NVO).
The FDA inspected the facility in July and determined that the inspection classification of this facility is "official action indicated" (OAI).
Also Read: Scholar Rock Stock Jumps On Additional Data From Pivotal Trial Of Muscular Dystrophy Treatment
In September, the FDA issued a Complete Response Letter (CRL) for Scholar Rock's apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).
The CRL is related to observations identified during a routine general site inspection of Catalent Indiana.
The observations are not specific to apitegromab. The CRL did not cite any other approvability concerns, including apitegromab's efficacy and safety data or the third-party drug substance manufacturer.
What Does This Mean For Apitegromab's Future?
The company said it is working with Novo Nordisk and requested a Type A meeting with the FDA to discuss next steps for resubmitting the BLA.
In March, the FDA accepted the company's Biologics License Application for apitegromab under priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2025.
In June, Scholar Rock revealed results from the Phase 2 EMBRAZE proof-of-concept trial assessing apitegromab in combination with tirzepatide to preserve lean mass during tirzepatide-induced weight loss.
The trial demonstrated that 30% of the total weight loss with tirzepatide alone was due to lean mass loss.
Apitegromab therapy (10 mg/kg) with tripeptide preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% (p=0.001) of lean mass compared to tripeptide alone, leading to higher-quality weight loss.
SRRK Price Action: Scholar Rock Holding shares were down 11.26% at $35.01 at the time of publication on Monday, according to Benzinga Pro data.
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