Scholar Rock Holding SRRK
Scholar Rock Holding reported a net loss of $107.24 million for Q3 2026.
Scholar Rock Holding (SRRK) filed a 10-Q with the SEC on Nov 10, 2026, 7:21 am ET. Source: the filing on SEC EDGAR.
Quarterly report, 15 new risk factors
- Form
- 10-Q
- Filed
- Importance
- Major
- Accession
- 0001193125-26-454434
- Revenue was $570,000 for the three months ended Sep 30, 2026.
- Net loss was $107.24 million for the three months ended Sep 30, 2026.
- Cash and equivalents were $366.27 million as of Sep 30, 2026.
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed since last quarter
15 new risk factors · 13 removed · 1 new legal mention
Compared with the 10-Q for the period ended Jun 30, 2026.
| This filing | Previous | Change vs prior 10-Q | |
|---|---|---|---|
| Operating income and margin | −$106.06M | −$108.9M | +2.6% |
| Net income | −$107.24M | −$109.9M | +2.4% |
| Operating cash flow | −$81.81M | −$70.31M | −16% |
| Cash | $366.27M | $437.09M | −16% |
New risk factors (15)
- • Our near-term prospects are wholly dependent on the successful commercialization of ISEMBYLD. We have limited experience commercializing an approved product, and if we are unable to successfully commercialize ISEMBYLD in the U.S. for its approved indication, our ability to generate meaningful revenue or achieve… +1 more paragraph
- • We have recently launched ISEMBYLD in the U.S. and are continuing to build and scale the infrastructure to support its successful commercialization in the U.S. and the potential future commercialization of apitegromab in additional jurisdictions, including Europe and Japan. If we are unable to successfully execute…
- On September 11, 2026, the FDA approved ISEMBYLD for the treatment of SMA in adults and children two years of age and older who are currently receiving SMN2-targeted treatment. We have recently launched ISEMBYLD in the U.S. for that indication. +17 more paragraphs
- The third-party fill-finish facility included in our original MAA received an OAI inspection classification from the FDA following inspections in 2025 and again in 2026. As a result, and following discussions with the EMA, we withdrew our original MAA and resubmitted the application in October 2026 to incorporate an…
- • the efficacy and safety of ISEMBYLD or other product candidates as demonstrated in clinical trials; +1 more paragraph
- and 10 more in the filing
Removed risk factors (13)
- • The regulatory approval process for apitegromab in the U.S., EU and other jurisdictions will be lengthy, time-consuming and inherently unpredictable and we may fail to receive or be delayed in receiving regulatory approval of apitegromab, or we may receive regulatory approval for only a subset of SMA patients. Our… +1 more paragraph
- • The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Success of a product candidate in an early-stage clinical trial may not be replicated in later-stage clinical trials.
- The regulatory approval process for apitegromab in the U.S., EU and other jurisdictions will be lengthy, time-consuming and inherently unpredictable and we may fail to receive or be delayed in receiving regulatory approval of apitegromab, or we may receive regulatory approval for only a subset of SMA patients. Our…
- In September 2025, we received a CRL from the FDA citing observations identified during an FDA inspection of a third-party fill-finish facility. This facility was issued a Form 483 by the FDA in July 2025 and the inspection classification of this facility is "official action indicated" (OAI). The observations were… +1 more paragraph
- We have received Rare Pediatric Disease designation for apitegromab for the treatment of SMA. However, a marketing application for apitegromab, if approved, may not meet the eligibility criteria for a rare pediatric disease priority review voucher. +4 more paragraphs
- and 8 more in the filing
New legal mentions (1)
- On November 9, 2026, the Company entered into an asset purchase agreement (the "PRV Asset Purchase Agreement") with BioNTech US Inc. (the "Buyer"), pursuant to which the Company agreed to sell its Rare Pediatric Disease Priority Review Voucher ("PRV") to Buyer for $205.0 million in cash upon the closing of the sale. +2 more paragraphs