SRRK Stock Gains After Company Drops Troubled Novo Nordisk-Owned Plant From FDA Filing

• Scholar Rock still expects a decision on its application by the September 30 target date.
• In September 2025, the FDA rejected Scholar Rock’s original biologics license application for apitegromab, solely because of manufacturing observations uncovered during a routine inspection of the Catalent Indiana facility.
• In Europe, the company withdrew its current application and is looking to refile.

Shares of Scholar Rock (SRRK) closed 2% higher on Friday after the Cambridge, Massachusetts-based biotech removed the mention of a controversial Novo Nordisk-owned fill-finish facility from its U.S. Food and Drug Administration (FDA) application for its spinal muscular atrophy drug.

Investors are now more optimistic about approval following the company’s previous application being rejected due to facility-related issues.

Novo-Owned Catalent Indiana Dropped

The company said 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. Review of the filing is progressing smoothly with an alternate U.S. manufacturing site, and Scholar Rock still expects a decision by the September 30 target date. The firm is ready to launch immediately if approved, with ample commercial vials already produced at the backup facility, it said.

That alternate plant is a proven U.S. site that already makes multiple commercial products and has cleared recent FDA and European inspections. Fill-finish is the final step of putting a biologic drug into sterile vials for patients.

Previous FDA Rejection Tied To Manufacturing

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.

The problems were not linked to the drug itself; regulators raised no concerns about apitegromab’s safety, efficacy data from late-stage trials, or the site that produced the active ingredient.

Scholar Rock resubmitted the application earlier this year, and the FDA is now set to decide by September 30.

Apitegromab is a drug designed to block myostatin, a protein that limits muscle growth. In SMA, progressive muscle weakness can rob patients of mobility; this is the first muscle-focused candidate to succeed in a pivotal late-stage trial.

Updates In International Markets

In Europe, Scholar Rock withdrew its application seeking approval. The company will refile using its alternate manufacturing site to seek the fastest path to a decision from European regulators, it said.

Japan’s drug agency, meanwhile, has agreed that no extra local clinical trials are needed. Scholar Rock plans to file its Japanese application by the end of 2026, based on existing data showing a favorable benefit-risk profile for the rare condition.

“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,” said CEO David L. Hallal.

How Did SRRK Retail Traders React?

On Stocktwits, retail sentiment around SRRK stock remained ‘bullish’ over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.

A Stocktwits user said that SRRK has the “largest potential” in their portfolio and expressed optimism that the stock will rally to $100.

SRRK stock has gained 28% year-to-date. 

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