Shares of Scholar Rock (NASDAQ: SRRK) closed 2% higher on Friday after the Cambridge, Massachusetts-based biotech removed a controversial Novo Nordisk-owned facility from its FDA filing for apitegromab.
The company confirmed it has, in accordance with FDA guidance, removed Catalent Indiana, a fill-finish plant now owned by Novo Nordisk, from its U.S. biologics license application for apitegromab.
Apitegromab is designed to treat spinal muscular atrophy by blocking myostatin, a protein that limits muscle growth, and is the first muscle-focused candidate to succeed in a pivotal late-stage trial.
Scholar Rock said review of the filing is progressing smoothly with an alternate U.S. manufacturing site already in place, and the company still expects a regulatory decision by the September 30 target date.
The firm added that it is ready to launch immediately upon approval, with ample commercial vials already produced at the backup facility.
That alternate plant is a proven U.S. site that manufactures multiple commercial products and has recently cleared both FDA and European inspections without issue.
In September 2025, the FDA issued a Complete Response Letter rejecting Scholar Rock’s original biologics license application for apitegromab solely because of manufacturing observations uncovered during a routine inspection of the Catalent Indiana facility.
Regulators raised no concerns about apitegromab’s safety, its efficacy data from late-stage trials, or the site responsible for producing the active ingredient itself.
Scholar Rock resubmitted the application earlier this year, and the FDA is now scheduled to deliver its decision by September 30.
In Europe, the company withdrew its current application and plans to refile using the alternate manufacturing site, seeking the fastest possible path to a decision from European regulators.
Japan’s drug agency has agreed that no additional local clinical trials are needed, and Scholar Rock plans to file its Japanese application by the end of 2026 based on existing data.
CEO David L. Hallal said, “We are very pleased with the continued constructive and collaborative engagement we have with regulators both in the U.S. and Europe and look forward to commencing our US launch in Q3 pending FDA approval.”
On Stocktwits, retail sentiment around SRRK remained bullish over the past 24 hours, while message volume climbed from low to normal levels following the announcement.
One Stocktwits user said that SRRK has the “largest potential” in their portfolio and expressed optimism that the stock would rally to $100.
SRRK stock has gained 28% year-to-date, with Friday’s move reflecting renewed investor confidence following the resolution of the manufacturing obstacle that previously derailed the approval process.
