--- title: "Scholar Rock Holding (SRRK) news: offering" url: "https://aibio.space/companies/scholar-rock/" publisher: "aibio.space (Biotech Investor Relations News)" summary: "SRRK offering news. Scholar Rock Holding news for investors: Scholar Rock is a Massachusetts biotech that makes antibodies against myostatin to improve…" --- Desk view · Opinion · Updated Oct 22, 2026 ## Scholar Rock gets its approval; the launch is next Scholar Rock has its first approved drug after a manufacturing-driven delay, with a modest motor-function gain with nominal p-values. The business now turns on launch uptake, the fracture signal and funding, since it still spends about $110 million a quarter. Read the full desk view aibio.space Investor Rank · Opinion **7** /10 Positive view Isembyld is approved, but the motor benefit is modest, fractures are a label concern, and cash lasts only into 2H 2027 at about $110 million spent per quarter. - **Technology**: 2/2 - **Odds**: 2/2 - **Balance sheet**: 0/2 - **Risk**: 1/2 - **Momentum**: 2/2 Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. [How the rank works](https://aibio.space/disclosures/#rank). - **Technology**: **Validated in phase 3.** Scholar Rock calls Isembyld the first muscle-targeted treatment for SMA, and it improved motor function 2.2 points on HFMSE over placebo in SAPPHIRE. - **Odds**: **Cleared for the lead drug.** Approval followed a manufacturing-related complete response letter, while FSHD and next-generation programs are early. - **Balance sheet**: **Funded into 2H 2027.** Cash was $492.1 million against $200.0 million of term loans, with a net loss near $110 million a quarter. - **Main risk**: **Launch and safety.** The label is narrow, fractures were 9% versus 2%, and the FDA added a pregnancy study and fracture alert reports. - **Watch next**: **Launch data and Europe.** The third-quarter report, SRK-439 phase 1 data in late 2026 and EMA timing guidance. ## Top news on Scholar 1. 2026-08-06 Financings [Scholar Rock files new $200 million at-the-market stock program](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) The Jefferies program replaces a November 2025 prospectus and has raised about $257.7 million in net proceeds to date. The filing came the day the company reported second-quarter results. ## Dates **Late 2026** Topline data from the phase 1 healthy-volunteer study of SRK-439 [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) **To be announced** Updated guidance on timing of a CHMP opinion on apitegromab in Europe [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) **From Sept. 11, 2026 (FDA approval)** Delayed-draw term loan commitment of up to $150.0 million becomes available [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) ## The money Cash, cash equivalents and marketable securities of $492.1 million at June 30, 2026; company says this funds operations into the second half of 2027. $200.0 million of term loans received from Blue Owl funds, with up to $150.0 million more available from FDA approval. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) No revenue in the second quarter of 2026; Isembyld was approved Sept. 11, 2026 and launch is underway. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) ## Risks on the record - In SAPPHIRE, fractures occurred in 9% of patients on Isembyld 10 mg/kg versus 2% on placebo. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_ex99-1.htm) - The FDA required a pregnancy safety study and asked for 15-day alert reports of fractures, which management initially misstated on its Sept. 14 call. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/tm2625438d1_8k.htm) - Net loss was $109.9 million in the second quarter of 2026 with no revenue, and the company says it will need additional capital. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) ## Questions investors ask ### What is aibio.space's Investor Rank for Scholar Rock Holding? 7 out of 10, our positive view. Isembyld is approved, but the motor benefit is modest, fractures are a label concern, and cash lasts only into 2H 2027 at about $110 million spent per quarter. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. [Source](https://aibio.space/disclosures/#rank) ### What did the FDA approve for Scholar Rock? On Sept. 11, 2026 the FDA approved Isembyld (apitegromab-mstn) for spinal muscular atrophy in adults and children aged two and older who are receiving an SMN2-targeted treatment. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_ex99-1.htm) ### How well did Isembyld work in the phase 3 trial? In SAPPHIRE, the 10 mg/kg dose improved HFMSE motor function by 2.2 points versus placebo at one year (nominal p=0.0121), and 34.2% of patients gained at least 3 points versus 13.5% on placebo. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_ex99-1.htm) ### What are the safety concerns with Isembyld? Fractures occurred in 9% of patients on 10 mg/kg versus 2% on placebo in SAPPHIRE. The FDA also required a pregnancy safety study and asked for 15-day alert reports of fractures. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/tm2625438d1_8k.htm) ### How much cash does Scholar Rock have? Scholar Rock had $492.1 million in cash, cash equivalents and marketable securities at June 30, 2026, which it says funds operations into the second half of 2027. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) ### Why did the FDA delay apitegromab earlier? In September 2025 the FDA issued a complete response letter over observations at the Catalent Indiana fill-finish site, which were not specific to apitegromab. Scholar Rock resubmitted on March 31, 2026 with a second site added. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/tm2610664d1_ex99-1.htm) ### What is the latest Scholar Rock Holding (SRRK) stock news? Our latest story on Scholar Rock Holding, dated Aug 6, 2026: "Scholar Rock files new $200 million at-the-market stock program". The Jefferies program replaces a November 2025 prospectus and has raised about $257.7 million in net proceeds to date. The filing came the day the company reported second-quarter results. [Source](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) ### What is Scholar Rock Holding's latest stock offering or financing news? Our latest financing story, dated Aug 6, 2026: "Scholar Rock files new $200 million at-the-market stock program". The Jefferies program replaces a November 2025 prospectus and has raised about $257.7 million in net proceeds to date. The filing came the day the company reported second-quarter results. [Source](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) ### Who were the underwriters or placement agents on Scholar Rock Holding's offering? From our story: Scholar Rock filed a prospectus supplement on Aug. 6 that lets it offer up to $200 million of common stock from time to time through Jefferies LLC as sales agent. [Source](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) ### How long will Scholar Rock Holding's cash last? From our story of Aug 6, 2026: The 10-Q says cash of $492.1 million is enough to fund operations into the second half of 2027, but that it will require more capital to complete development and commercialization of its programs. [Source](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) ### How much cash does Scholar Rock Holding have? From our story of Aug 6, 2026: The 10-Q says cash of $492.1 million is enough to fund operations into the second half of 2027, but that it will require more capital to complete development and commercialization of its programs. [Source](https://aibio.space/news/scholar-rock-files-new-200-million-market-stock-program/) ### What is Scholar Rock Holding's market cap? We do not publish live share prices. In its annual report, Scholar Rock Holding Corporation put the market value of shares held by non-affiliates (public float) at $2.60 billion as of Jun 30, 2025. Source ### Is Scholar Rock Holding a smaller reporting company? SEC records list Scholar Rock Holding Corporation's filer category as: Non-accelerated filer. Source ### Where is Scholar Rock Holding headquartered? SEC records list its business address as 301 BINNEY STREET, CAMBRIDGE, MA, 02142. Source ### When does Scholar Rock Holding's fiscal year end? Scholar Rock Holding Corporation's fiscal year ends on December 31, per SEC records. Source ## Legal and investor matters Checked against Scholar Rock Holding filings and press releases. Allegations are allegations; nothing here is a finding of fault. Reviewed Oct 25, 2026. Part II, Item 1 of the 10-Q filed 2026-08-06 states that, as of the date of that report, Scholar Rock does not believe it is party to any claim or litigation whose adverse outcome would reasonably be expected to have a material adverse effect on its business. It covers that quarterly report only. [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) 1. 2026-09-11 Other FDA approves Scholar Rock's apitegromab for spinal muscular atrophy Scholar Rock announced on 2026-09-11 that the FDA approved ISEMBYLD (apitegromab-mstn) for spinal muscular atrophy in adults and children 2 years and older who are currently receiving a survival SMN2 targeted treatment. The approval follows a BLA resubmission announced on 2026-03-31, after the FDA issued a complete response letter in September 2025. The company reported the approval in an 8-K filed 2026-09-14. [Scholar Rock 8-K filed 2026-09-14](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm) 2. 2026-08-06 Financing Scholar Rock files new $200 million at-the-market prospectus supplement On 2026-08-06 Scholar Rock filed a prospectus supplement to sell additional common stock with an aggregate offering price of up to $200 million through Jefferies under its at-the-market program. It replaces the supplement dated 2025-11-14 and ends that offering. The company said it had raised approximately $257.7 million in net proceeds under the program to date. [Scholar Rock 8-K filed 2026-08-06](https://www.sec.gov/Archives/edgar/data/1727196/000110465926091702/tm2622083d2_8k.htm) 3. 2025-12-02 Regulatory Scholar Rock fill-finish site receives FDA warning letter after OAI classification Scholar Rock reported that its third-party fill-finish site, Catalent Indiana, part of Novo Nordisk, received an FDA warning letter after the FDA classified the facility inspection as official action indicated. The company said that, based on a Type A meeting on 2025-11-12 and information from Catalent, it still anticipated resubmitting the apitegromab BLA and launching in the U.S. in 2026. [Scholar Rock 8-K filed 2025-12-02](https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/tm2532170d1_8k.htm) 4. 2025-09-23 Regulatory FDA issues complete response letter for apitegromab BLA Scholar Rock announced on 2025-09-23 that the FDA issued a complete response letter for its BLA for apitegromab for spinal muscular atrophy. The company's later 10-Q states that the letter related to observations from a routine inspection of a third-party fill-finish facility, which received a Form 483 in July 2025. The company said it would need to resubmit the BLA, delaying progress toward commercialization. [Scholar Rock 8-K filed 2025-09-23](https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm) 5. 2025-06-03 Governance Scholar Rock replaces Ernst & Young with Deloitte as auditor Ernst & Young told Scholar Rock on 2025-05-06 that it declined to stand for re-election as auditor for fiscal 2025. EY's reports for 2024 and 2023 had no adverse opinion, and the company reported no disagreements or reportable events. On 2025-06-03 the audit committee appointed Deloitte & Touche LLP after a competitive process. [Scholar Rock 8-K filed 2025-06-03](https://www.sec.gov/Archives/edgar/data/1727196/000155837025008364/srrk-20250603x8k.htm) 6. 2025-04-26 Governance Scholar Rock names David Hallal CEO as Jay Backstrom steps down On 2025-04-26 the board appointed David Hallal, chairman since 2017, as chief executive officer effective 2025-04-27. Jay Backstrom moved to senior advisor through 2025-10-31 and left the board. The company said his resignation was not the result of any disagreement. The board also named a new chief operating officer, chief financial officer and president of R&D. [Scholar Rock 8-K filed 2025-04-28](https://www.sec.gov/Archives/edgar/data/1727196/000110465925039854/tm2513330d1_8k.htm) ## Pipeline | Program | Indication | Stage | |---|---|---| | Isembyld (apitegromab-mstn) | Spinal muscular atrophy, patients 2 years and older on SMN2-targeted therapy | FDA approved Sept. 11, 2026; EMA review ongoing [Source](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_ex99-1.htm) | | Apitegromab (FORGE) | Facioscapulohumeral muscular dystrophy (FSHD) | Phase 2, about 60 patients, initiated 2026 [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) | | Apitegromab (OPAL) | SMA in infants and toddlers under 2 | Phase 2, enrolling [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) | | Apitegromab, subcutaneous formulation | SMA | Development path to be aligned with FDA and EMA after approvals [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) | | SRK-439 | Myostatin inhibition, muscle mass (subcutaneous) | Phase 1 in healthy volunteers; topline expected late 2026 [Source](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-ex99_1.htm) | ## Stock chart Price chart and quote supplied by TradingView, delayed as the exchange requires. 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[Open NASDAQ:SRRK on TradingView](https://www.tradingview.com/symbols/NASDAQ-SRRK/). ## SEC filings and registration - **SEC name**: Scholar Rock Holding Corp - **CIK**: 1727196 - **Industry (SIC)**: Biological Products, (No Diagnostic Substances) (2836) - **US tickers**: SRRK (Nasdaq) - **State or country of incorporation**: DE - **Fiscal year ends**: December 31 - **Filer category**: Non-accelerated filer - **Business address**: 301 BINNEY STREET, CAMBRIDGE, MA, 02142 - **Phone**: 857-259-3860 - **Shares outstanding**: 121,785,282 as of 2026-08-03 (10-Q filed 2026-08-06) ### Recent filings (8-K and 6-K are the company's own announcements) - [8-K](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/tm2625438d1_8k.htm) filed 2026-09-15 - [8-K](https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm) filed 2026-09-14 - [8-K](https://www.sec.gov/Archives/edgar/data/1727196/000110465926091702/tm2622083d2_8k.htm) filed 2026-08-06 - [424B5](https://www.sec.gov/Archives/edgar/data/1727196/000110465926091699/tm2622083-1_424b5.htm) filed 2026-08-06 - [10-Q](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336732/srrk-20260630.htm) filed 2026-08-06 - [8-K](https://www.sec.gov/Archives/edgar/data/1727196/000119312526336715/srrk-20260806.htm) filed 2026-08-06 - [8-K](https://www.sec.gov/Archives/edgar/data/1727196/000110465926070636/srrk-20260604x8k.htm) filed 2026-06-05 - [10-Q](https://www.sec.gov/Archives/edgar/data/1727196/000110465926056667/srrk-20260331x10q.htm) filed 2026-05-07 Source: [SEC EDGAR](https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001727196), retrieved October 23, 2026. Shares outstanding is the cover-page figure from the latest periodic report. The SEC does not publish share prices. Who manages this page **This page is managed by aibio.space.** The company does not run, edit or pay for this page. News, desk views and Investor Ranks are written and managed independently by aibio.space under our editorial and analytical judgment. Opinion only, not investment advice. [How we work](https://aibio.space/disclosures/#paid) · [Terms](https://aibio.space/terms/#news) · [Request a correction](https://aibio.space/reputation/#update) --- Source page: https://aibio.space/companies/scholar-rock/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Scholar Rock Holding (SRRK) news: offering", 2026-10-31, https://aibio.space/companies/scholar-rock/