IndustryCompany release

Scholar Rock begins US launch of Isembyld as EU and Japan reviews progress

🇺🇸 Scholar Rock Holding Corp (SRRK) · Tue 10 Nov 2026

The company's Q3 2026 update also confirms a $205M priority review voucher sale and the start of dosing in a Phase 2 facioscapulohumeral muscular dystrophy study.

Scholar Rock said on 10 November 2026, in its third-quarter earnings presentation, that it is now launching Isembyld (apitegromab-mstn) in the US. The FDA has approved the product for spinal muscular atrophy (SMA) in patients aged 2 years and older who are already receiving therapy that targets SMN.

Regulatory reviews are continuing outside the US. The company expects a CHMP opinion on its resubmitted marketing authorisation application to the European Medicines Agency in the first half of 2027. In Japan, the PMDA is assessing the Japanese new drug application under priority review.

Scholar Rock also reported that it has signed a definitive agreement to sell its priority review voucher for $205M. Such vouchers, awarded by the FDA under certain programmes, can be sold and used to obtain a shortened review time for a later application.

In its pipeline, the company has begun dosing in FORGE, a Phase 2 study in facioscapulohumeral muscular dystrophy (FSHD). The FDA has granted the programme Fast Track and Orphan Drug designations.

What it means for your team

  • Market-access teams in SMA should note the US launch, which makes Isembyld available to patients aged 2 and older already on SMN-targeted therapy.
  • Regulatory teams should track the expected CHMP opinion in H1 2027 as the next EU milestone for the resubmitted MAA.
  • The PMDA priority review in Japan means the company is advancing a parallel regulatory pathway there.
  • The FSHD study with Fast Track and Orphan Drug designations signals a possible expansion of the company's neuromuscular pipeline.

Company's press release (SEC filing): Scholar Rock Holding Corp ↗

Article written by VigiEye from the official source (Scholar Rock Holding Corp). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →