SRRK Stock Surges To Near Five-Year Highs – Here’s Why Analysts Are Bullish About Its Latest FDA Filing

• Raymond James raised the price target to $60 from $53, while maintaining a ‘Strong Buy’ rating, according to The Fly.
• H.C. Wainwright called the resubmission a ‘material de-risking event.’
• The FDA is expected to announce a potential decision by September 2026.

Shares of Scholar Rock (SRRK) garnered significant retail attention on Tuesday after the pharmaceutical firm resubmitted its Biologics License Application with the U.S. Food and Drug Administration for a potential treatment of Spinal Muscular Atrophy.

The resubmission follows earlier feedback tied to manufacturing inspections, rather than concerns about the drug itself. The treatment, Apitegromab, has shown meaningful improvements in motor function in late-stage trials.

SRRK’s shares gained 12% to hit their highest levels since April 2021.

Raymond James Sees Strong Uptake

Raymond James raised its price target on the stock to $60 from $53, while maintaining a ‘Strong Buy’ rating, according to The Fly. If approved, Apitegromab could see strong uptake, analyst Martin Auster said.

H.C. Wainwright maintained its ‘Buy’ rating and the $58 price target. Analyst Andres Maldonado said the “chapter colored by regulatory setbacks is coming to a close for Scholar Rock as they move forward with strengthened FDA alignment, increased manufacturing redundancy, and clear commercial readiness.”

The firm also sees the resubmission as a ‘material de-risking event’, improving the chances of approval and an early commercial rollout.

FDA’s Potential Decision By September

The updated filing now includes manufacturing support from Catalent Indiana, along with a second U.S.-based fill-finish facility to strengthen supply. The FDA is expected to accept the application within 30 days, followed by a review period of up to six months, with a potential decision by September 2026.

The therapy has already received multiple key designations from the FDA, including Fast Track, Orphan Drug, Priority Review, and Rare Pediatric Disease status. Meanwhile, the European Medicines Agency (EMA) has granted it both Priority Medicines (PRIME) and Orphan Medicinal Product designations.

“As we execute our plans for both Catalent Indiana and our second fill-finish facility, we look forward to anticipated apitegromab approvals and launches in both the U.S. and Europe this year,” said David L. Hallal, Chairman and CEO of Scholar Rock.

How Did Retail Traders React?

Retail sentiment on Stocktwits turned ‘bullish’ from ‘neutral’ a day earlier.

One user said the company is highly likely to become an M&A target.

Year-to-date, the stock has gained around 10%.

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