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CORRECTING and REPLACING Scholar Rock Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights

Key Takeaway: Scholar Rock reported its financial results for Q4 and full year 2025, highlighting a net loss of $91 million for the quarter. The company is focused on advancing its SMA treatment, apitegromab, and is preparing for a resubmission of its BLA pending FDA reinspection. The CEO expressed optimism for 2026 as a transformative year for the company.
Price reaction · baseline $44.31 (2026-03-03 close) · hit pre-market · clean, no other SRRK news in the window
day 0 close · peak
+7%
day 1
+4.2%
day 3
-0.2%

Market Sentiment Analysis

POSITIVE FACTORS

  • Scholar Rock is advancing its pipeline with apitegromab.
  • The company expects 2026 to be a transformative year.
  • FDA engagement is encouraging for regulatory review.

CONCERNS & RISKS

  • Net loss increased significantly compared to the previous year.
  • Concerns over the remediation of the Catalent Indiana facility.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+68%
120-day peak, hindsight
Typical move
8.7%
average across 5 past catalysts
Cash runway
~21 mo
Low dilution risk
Lead asset
Apitegromab
Phase 3 · Spinal Muscular Atrophy

Full Press Release Details

CAMBRIDGE, Mass.--(BUSINESS WIRE)--In the release, the first paragraph of the Fourth Quarter and Full Year 2025 Financial Results section, second sentence should read: Net loss per common share was $0.76 for the quarter ended December 31, 2025, compared to $0.61 per common share for the quarter ended December 31, 2024. (instead of Net loss per common share was $0.88 for the quarter ended December 31, 2025, compared to $0.61 per common share for the quarter ended December 31, 2024.) In the Condensed Consolidated Statements of Operations table, Net loss per share, basic and diluted for the Three Months Ended December 31, 2025 should read: $(0.76) (instead of $(0.88)) and the Weighted average common shares outstanding, basic and diluted for the Three Months Ended December 31, 2025 should read: 120,449,524 (instead of 103,087,377).
The updated release reads:
SCHOLAR ROCK REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology to advance musculoskeletal health, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent company developments.
“Our highest priority is to serve children and adults living with SMA by bringing apitegromab through the regulatory review process as quickly as possible,” said David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock. “To that end, we are encouraged by the FDA’s continued engagement and shared sense of urgency as Novo Nordisk works expeditiously to remediate its Catalent Indiana facility. We are ready to resubmit our apitegromab BLA following successful reinspection of the site by the FDA.”
Mr. Hallal continued, “As we prepare to usher in the next phase of innovation for patients with SMA, we continue to strengthen our financial position while aggressively advancing our pipeline and expect 2026 to be a transformative year for Scholar Rock.”
Business Highlights and Upcoming Milestones
Apitegromab
Apitegromab is an investigational fully human monoclonal antibody designed to inhibit myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. It is the first and only muscle-targeted therapeutic candidate in spinal muscular atrophy (SMA) to demonstrate a statistically significant and clinically meaningful benefit in a pivotal Phase 3 clinical trial (SAPPHIRE).
SMA Program
FSHD Program
SRK-439
SRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that binds to pro- and latent myostatin with high affinity and selectivity (i.e., no GDF11 or Activin A binding). Based on preclinical data, SRK-439 has the potential to potently inhibit myostatin and increase muscle mass.
Corporate Update
Fourth Quarter and Full Year 2025 Financial Results
Scholar Rock reported a net loss of $91.0 million, including stock-based compensation of $19.4 million, for the quarter ended December 31, 2025, compared to a net loss of $66.5 million, including stock-based compensation of $9.5 million, for the quarter ended December 31, 2024. Net loss per common share was $0.76 for the quarter ended December 31, 2025, compared to $0.61 per common share for the quarter ended December 31, 2024. For the full year ended December 31, 2025, Scholar Rock reported a net loss of $377.9 million, including stock-based compensation of $75.6 million, compared to a net loss of $246.3 million for the year ended December 31, 2024, including stock-based compensation of $36.6 million. Net loss per common share was $3.29 for the full year ended December 31, 2025, compared to $2.47 per common share for the full year ended December 31, 2024.
Conference Call Information
Scholar Rock will host a conference call and webcast today, Tuesday, March 3, at 8:00 a.m. ET to review its fourth quarter and full year 2025 financial results and discuss recent business updates. To access the live audio webcast, please go to “Events and Presentations” in the Investors section of the Scholar Rock website athttp://investors.scholarrock.com.
To participate via telephone, please register in advancehere. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call. A replay of the webcast will be available on the Company’s website for approximately 90 days.
About Scholar Rock
Scholar Rock is a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Scholar Rock® is a registered trademark of Scholar Rock, Inc.
Availability of Other Information About Scholar Rock
Investors and others should note that we communicate with our investors and the public using our company websitewww.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly known as Twitter) and LinkedIn. The information that we post on our website or on X (formerly known as Twitter) or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials for apitegromab, SRK-439 and its preclinical programs, and indication selection and development timing, including the timing of any regulatory submissions and anticipated approvals, the therapeutic potential, clinical benefits and safety of any product candidates, its ability to address the observations identified in the complete response letter, expectations regarding resubmission and timing of its BLA for apitegromab upon the successful FDA reinspection of Catalent Indiana, expectations regarding commercial launch timing in the U.S. and in Europe, expectations regarding a new fill finish facility and the achievement of important milestones, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “could,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, without limitation, whether preclinical and clinical data, including the results from the Phase 3 SAPPHIRE trial, will be sufficient to support regulatory approval, that preclinical and clinical data, including the results from the Phase 2 or Phase 3 clinical trial of apitegromab, or the preclinical data for SRK-439, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidates; whether the FDA will accept the remediations to the Novo Nordisk Bloomington Indiana fill finish facility in response to the FDA Observations, whether Scholar Rock will be able to resubmit its BLA in a timely manner and whether the updated BLA will be sufficient to support regulatory approval, Scholar Rock’s ability to manage expenses or provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; information provided or decisions made by regulatory authorities; competition from third parties that are developing products for similar uses; Scholar Rock’s ability to obtain, maintain and protect its intellectual property; and Scholar Rock’s dependence on third parties for development and manufacture of product candidates including, without limitation, to supply any clinical trials as well as those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.
Scholar Rock Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months EndedDecember 31, Years EndedDecember 31,
2025 2024 2025 2024
Operating expenses
Research and development $ 46,875 $ 50,365 $ 208,440 $ 184,550
General and administrative 45,021 18,992 176,205 67,504
Total operating expenses 91,896 69,357 384,645 252,054
Loss from operations (91,896 ) (69,357 ) (384,645 ) (252,054 )
Other income (expense), net 931 2,903 6,706 5,760
Net loss $ (90,965 ) $ (66,454 ) $ (377,939 ) $ (246,294 )
Net loss per share, basic and diluted $ (0.76 ) $ (0.61 ) $ (3.29 ) $ (2.47 )
Weighted average common shares outstanding, basic and diluted 120,449,524 109,520,287 114,701,154 99,838,102
Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
December 31, 2025 December 31, 2024
Assets
Cash, cash equivalents and marketable securities $ 367,563 $ 437,278
Other current assets 17,584 13,887
Total current assets 385,147 451,165
Other assets 19,125 23,757
Total assets $ 404,272 $ 474,922
Liabilities and Stockholders' Equity
Current liabilities $ 55,419 $ 46,936
Long-term liabilities 103,365 59,352
Total liabilities 158,784 106,288
Total stockholders' equity 245,488 368,634
Total liabilities and stockholders' equity $ 404,272 $ 474,922

Frequently Asked Questions

What was Scholar Rock's net loss for Q4 2025?

Scholar Rock reported a net loss of $91 million for Q4 2025.

What is apitegromab?

Apitegromab is an investigational monoclonal antibody for treating SMA.

When will Scholar Rock resubmit its BLA?

Scholar Rock plans to resubmit its BLA after FDA reinspection of its facility.

What are the expectations for Scholar Rock in 2026?

Scholar Rock anticipates 2026 to be a transformative year for the company.

Last updated: Mar 4, 2026