Scholar Rock (SRRK) reported Q3 2025 results with a larger loss as it prepares for potential commercialization. Net loss was $102.2 million for the quarter and $287.0 million for the nine months. Operating expenses rose to $103.6 million in Q3, driven by higher R&D to support apitegromab and pipeline work, and sharply higher G&A for launch readiness, equity-based comp, and professional services.
Liquidity remains solid. Cash, cash equivalents and marketable securities totaled $369.6 million as of September 30, 2025, with long‑term debt of $99.6 million. The company raised $91.7 million net through its ATM in 2025 (2,767,000 shares) and drew an additional $50.0 million term loan on September 29, bringing total term loans funded to $100.0 million. Shares outstanding were 102,007,457 as of November 5, 2025.
Regulatory update: The FDA issued a Complete Response Letter in September tied to site‑related observations at a third‑party fill‑finish facility; no efficacy or safety issues were cited. Scholar Rock held a Type A meeting in November and plans to resubmit the apitegromab BLA when the facility is reclassified. The EMA validated the apitegromab MAA in March 2025.
Scholar Rock Holding Corporation (SRRK) furnished an update regarding its quarterly results process. The company issued a press release with financial and operating results for the quarter ended September 30, 2025, furnished as Exhibit 99.1.
It also furnished presentation slides as Exhibit 99.2 for a conference call scheduled for 8:00 am ET on November 14, 2025. The press release and slides are furnished, not filed, under the Exchange Act.
Scholar Rock (SRRK) reported an update under Other Events. On October 10, 2025, the company was informed by Novo Nordisk that the U.S. Food and Drug Administration has classified the Catalent Indiana, LLC facility as “official action indicated.”
The classification follows a Form FDA 483 issued to Catalent Indiana, LLC on July 14, 2025. The filing does not provide additional details or actions beyond noting the FDA’s inspection outcome.
David Hallal, who serves as Chief Executive Officer and a Director of Scholar Rock Holding Corp (SRRK), transferred 205,000 shares of the issuer's common stock to the Hallal Family Irrevocable Trust - 2012 on 10/08/2025 for no consideration (reported price $0). The filing notes the reporting person’s spouse is a trustee of the trust and that he disclaims beneficial ownership of the transferred shares except to the extent of any pecuniary interest.
After the reported transfer, the filing shows the reporting person beneficially owns 1,599,095 shares, consisting of 99,095 shares of common stock and 1,500,000 restricted stock units. The statement was signed by an attorney-in-fact on 10/09/2025.
Samsara-affiliated investors increased and reshuffled holdings in Scholar Rock Holding Corp (SRRK). The group—Samsara BioCapital, L.P., its GP entities, Samsara Opportunity Fund and Dr. Srinivas Akkaraju—reports combined beneficial ownership of 6,991,553 shares, representing 7.2 of the outstanding common stock on the filing date. The amendment discloses an internal private sale on 10/03/2025 where Samsara Opportunity Fund bought 276,578 shares from Samsara LP for $37.44 per share ($10,355,080.32 total) and multiple open-market purchases on 10/03/2025 and 10/06/2025 at weighted-average prices between $35.61 and $39.52 per share. The filing confirms voting and dispositive power structures: Samsara GP and Samsara Opportunity GP and Dr. Akkaraju control voting for the partnership-held shares. The disclosure updates prior Schedule 13D filings and attaches a joint filing agreement.
Srinivas Akkaraju, a director, reported multiple purchases of Scholar Rock Holding Corp (SRRK) common stock in early October 2025. The filings show net additions through affiliated vehicles, primarily Samsara Opportunity Fund, L.P., bringing the fund's reported beneficial ownership to 500,439 shares following purchases executed on 10/03/2025 and 10/06/2025. Purchase prices are disclosed as weighted averages across multiple trades, with reported ranges from $35.14 up to $39.84 depending on the tranche. The report also notes prior shares held by Samsara BioCapital, L.P. and contains standard disclaimers that the reporting person disclaims beneficial ownership except to the extent of pecuniary interest.
Mo Qatanani, Chief Scientific Officer of Scholar Rock Holding Corp (SRRK), reported an insider sale on a Form 4. On 09/22/2025 the reporting person sold 3,353 shares of Scholar Rock common stock at a weighted average price of $30.6729 under a Rule 10b5-1 trading plan adopted March 31, 2025. After the sale the reporting person beneficially owns 108,964 shares represented by RSUs. The Form 4 was signed by an attorney-in-fact on behalf of the reporting person and filed on 09/24/2025. The filing discloses the sale occurred in multiple transactions at prices ranging from $30.33 to $30.85, and the weighted average reflects those executions.
Scholar Rock Holding Corporation reported that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for its Biologics License Application for apitegromab, a treatment candidate for spinal muscular atrophy (SMA). The company disclosed that it announced the CRL in a press release dated September 23, 2025, which is furnished as an exhibit. A CRL means the FDA has completed its review of the application and, instead of approving it in its current form, has provided feedback that must be addressed before approval can be granted.
Scholar Rock Holding Corp (SRRK) filed a Form 144 disclosing a proposed sale of 3,353 common shares through J.P. Morgan Securities LLC on 09/22/2025 with an aggregate market value of $102,846. The shares were acquired on 09/15/2025 as a restricted stock award from the issuer and were paid for on the acquisition date. The filing reports 67,122,987 shares outstanding for the class. The notice also lists a prior sale on 07/08/2025 where Mohammed Qatanani sold 24,066 shares for gross proceeds of $828,897. The filer affirms they are not aware of undisclosed material adverse information and references Rule 10b5-1 trading plan disclosure language.
Katie Peng, a director of Scholar Rock Holding Corp (SRRK), reported sales of common stock on 09/16/2025 under a Rule 10b5-1 plan adopted 11/20/2024 to cover tax obligations from RSU vesting. The filing shows two sale events: 930 shares sold at a weighted average price of $32.4761 and 76 shares sold at a weighted average price of $33.1963, executed in multiple transactions at prices ranging $31.85–$33.73. After these sales Ms. Peng beneficially owns 33,990 shares following the first reported sale and 33,914 shares following the second, held directly and including unvested RSUs. The Form 4 was signed by an attorney-in-fact on 09/17/2025.