• Scholar Rock held a meeting with the FDA earlier this month to discuss the application.
• The third-party facility under question is undertaking remedies under new owners, Scholar Rock said. 
• The company also said that it has identified an additional fill-finish facility for Apitegromab.

Scholar Rock (SRRK) announced on Friday that it expects to resubmit its application for Apitegromab for children and adults with spinal muscular atrophy in 2026, following the U.S. Food and Drug Administration's rejection of approval earlier this year.

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Shares of the company traded 26% higher on Friday afternoon at the time of writing.

The FDA refused to approve Apitegromab in September after raising concerns identified during a routine general site inspection of Novo Nordisk-owned Catalent Indiana LLC, a third-party fill-finish facility. The agency did not make any observations specific to its drug or cite any other approvability concerns, including any pertaining to Apitegromab’s efficacy and safety data, the company then said.

Meeting With FDA

Scholar Rock stated on Friday that it held an in-person “constructive” meeting with the FDA regarding the therapy. Catalent Indiana participated in the meeting and presented the progress made in implementing remedies at the facility, it said. Catalent also confirmed to the FDA that the facility is on track to be ready for another inspection by the end of the year.

The company also said that it has identified an additional fill-finish facility for Apitegromab. The second facility, based in the U.S., has a proven track record of successful site inspections, the company stated. Tech transfer is underway, and commercial capacity has been reserved beginning in the first quarter of 2026, it added.

Scholar Rock CEO David L. Hallal said on the company’s earnings call that while there is “history” at the Catalent Indiana facility, it largely links back to ownership. Novo Nordisk acquired the facility in December, and Hallal now expects Novo to turn things around.

“We would expect that our BLA would be resubmitted with Catalent as our primary filler, and we would expect a second filler to be added to our file, which was, frankly, always going to be our plan anyway, given the fact that Novo wants that facility for internal purposes. That is the path that we are following,” he added.

Q3 Earnings

For the third quarter, Scholar Rock reported a net loss per share of $0.90, compared to a loss of $0.66 per share in the corresponding quarter of 2024. The increase in loss was spurred by a rise in expenses, including investments in commercial manufacturing and launch readiness for Apitegromab.

The company ended the quarter with cash, cash equivalents, and marketable securities of approximately $369.6 million, which, in addition to cash from common warrants that expire this year-end, is expected to be sufficient to fund operations into 2027, the company said.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around SRRK stock rose from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘high’ levels.

SRRK stock is down 12% this year and up approximately 38% over the past 12 months. 

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