SRRK
Scholar Rock Holding Corp.
September 15, 2026 · market open
- Rarity
- 1.89
- Peak move
- −9.87%
- Float cap
- $4.4B
Scholar Rock is a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy and additional rare, severe, and debilitating neuromuscular diseases. It develops monoclonal antibodies that selectively target latent forms of growth factors, including apitegromab for SMA and facioscapulohumeral muscular dystrophy, and SRK-439 for rare neuromuscular diseases.
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What we found
17 events · 3 from SEC or newswire · 0 timed with the movereg_fd_disclosureScholar Rock disclosed in an SEC Regulation FD filing that during its September 13-14, 2026 investor call management incorrectly said the FDA required no post-marketing safety commitments for ISEMBYLD; the FDA actually required a pregnancy safety study and 15-day alert reports on fractures, and the company clarified this afterward.
SEC8-K 0001104659-26-107721Webarchive.fast-edgar.comSEC8-K 0001104659-26-107721Webtipranks.comWebinvesting.comWebhi.investing.comanalyst_ratingH.C. Wainwright raised its price target on Scholar Rock (SRRK) to $70 from $65 while maintaining a Buy rating, after FDA approval of apitegromab (ISEMBYLD) for spinal muscular atrophy, and moved its probability of success from 95% to 100%; it said the ISEMBYLD label came in about as broad as hoped.
analyst_ratingWedbush reiterated an Outperform rating on Scholar Rock (SRRK) with a $64 price target, citing about 15.5% upside from the $55.41 opening price.
- Key event
reg_fd_disclosureScholar Rock furnished a press release and presentation materials on its September 11, 2026 ISEMBYLD FDA approval and said it would host a webcast and conference call on September 14, 2026 to discuss the approval.
SEC8-K 0001104659-26-107273 analyst_ratingBMO Capital Markets reiterated an Outperform rating on Scholar Rock on Sept 10, 2026.
- Key event
analyst_ratingTruist Securities raised its price target on Scholar Rock to $76 from $55 and kept a Buy rating, citing the earlier-than-expected FDA approval of apitegromab (ISEMBYLD) for SMA patients aged 2 and older.
- Key event
analyst_ratingRaymond James raised its price target on Scholar Rock to $72 from $65 and maintained a Strong Buy rating after the FDA approval of ISEMBYLD, citing rapid U.S. commercial uptake potential and adequate supply, and estimating 2035 apitegromab revenue of about $2.2 billion.
analyst_ratingTD Cowen reiterated its Buy rating and $71 price target on Scholar Rock following the broad FDA label for Isembyld, projecting $2 million in US Q4 2026 sales and $2.3 billion in peak US revenue by 2035.
analyst_ratingBarclays analyst Etzer Darout downgraded Scholar Rock (SRRK) to Equal Weight from Overweight with a $58 price target, up from $55, citing balanced risk/reward and valuation after the Isembyld approval.
analyst_ratingCitigroup reiterated a Buy rating on Scholar Rock (SRRK) on September 14, 2026.
product_launchScholar Rock said Isembyld (apitegromab) will be available to ship in the coming days; the drug is given as a monthly intravenous infusion and is expected to launch with a miscellaneous J-code.
analyst_ratingJefferies Financial Group reiterated a Buy rating on Scholar Rock (NASDAQ:SRRK) on September 14, 2026.
analyst_ratingPiper Sandler analyst Allison Bratzel raised the price target on Scholar Rock (SRRK) to $75 from $60, keeping an Overweight rating, calling the fracture-risk label language and stock reaction overdone.
regulatory_approvalThe FDA approved Scholar Rock's ISEMBYLD (apitegromab-mstn) for spinal muscular atrophy in adults and children 2 years and older receiving an SMN2-targeted treatment, based on the Phase 3 SAPPHIRE trial, earlier than the Sept 30, 2026 PDUFA date; the approval carries a Rare Pediatric Disease Priority Review Voucher and U.S. launch is underway with product shipping in coming days.
trading_haltTrading in Scholar Rock shares was halted in aftermarket trading on Sept 11, 2026 for pending news ahead of the FDA approval of ISEMBYLD for spinal muscular atrophy.
executive_appointmentScholar Rock named Akshay Vaishnaw, formerly Alnylam's head of R&D, as president of research and development, and said SRK-439 initial data is expected by year-end 2026 or January 2027.
executive_remarkAt investor conferences, Scholar Rock CEO David Hallal outlined the pipeline and launch plans, including the FDA PDUFA decision on apitegromab for SMA about 20-21 days from September 30, 2026, an alternate fill-finish site replacing Catalent Indiana as the commercial path, a planned Japan PMDA filing by year-end, and launch readiness with 140 U.S. treatment centers and a 10,000-nurse home-infusion network.