- \n
- Apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA) review by FDA continues to advance with two fill-finish facilities, representing two independent paths to an FDA approval decision by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date<\/i><\/li>\n
- FDA review of second fill-finish facility progressing; Data package for FDA review of second fill-finish facility has been submitted; Ample supply available for commercialization upon FDA approval<\/i><\/li>\n
- Scholar Rock is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026<\/i><\/li>\n
- Company engaging with European Medicines Agency (EMA) on next steps for apitegromab Marketing Authorisation Application (MAA); FDA inspection classification of Catalent Indiana LLC (part of Novo Nordisk) is pending<\/i><\/li>\n
- Initiated Phase 2 FORGE study evaluating apitegromab in patients with facioscapulohumeral muscular dystrophy (FSHD)<\/i><\/li>\n
- Cash, cash equivalents, and marketable securities of $492 million as of June 30, 2026; Includes $63 million in net cash proceeds from Company\u2019s at-the-market (ATM) program<\/i><\/li>\n
- Management to host a conference call today at 8:00 a.m. ET<\/i><\/li>\n<\/ul>\n
CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nScholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, today reported financial results for the second quarter ended June 30, 2026, and provided an update on recent company developments.<\/p>\n\n\u201cWe are on the threshold of securing the world\u2019s first ever regulatory approval of a myostatin inhibitor, which will also be the first ever muscle-targeted treatment for children and adults living with SMA,\u201d said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock. \u201cBacked by a strong balance sheet, our Scholar Rock team is ready to usher in the next phase of innovation for the SMA community in the U.S. immediately upon apitegromab approval.\u201d<\/p>\n
Business Highlights and Upcoming Milestones<\/b><\/p>\n
Apitegromab<\/span><\/b><\/p>\n
\nApitegromab 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 SMA to demonstrate a statistically significant and clinically meaningful benefit in a pivotal Phase 3 clinical trial (SAPPHIRE).<\/p>\n
SMA Program<\/b><\/p>\n
- \n
- Apitegromab Biologics License Application (BLA) on track for potential FDA approval by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date. <\/b>The FDA review of the apitegromab BLA is advancing with both the Catalent Indiana fill-finish facility and a second fill-finish facility, representing two independent paths to an FDA approval decision.At the March 2026 Type C meeting, FDA and Scholar Rock agreed to the data package required for FDA review of the second fill-finish facility. That data package has been submitted, and Agency review of the data is progressing well. Ample supply from the second fill-finish facility is available for commercialization upon FDA approval. The FDA inspection classification of Catalent Indiana following an April 2026 general site inspection is pending.\n<\/li>\n
- U.S. Commercial team prepared to launch apitegromab upon FDA approval. <\/b>The U.S. Commercial team remains active in the field with SMA prescribers and centers of excellence nationwide, furthering disease education and awareness initiatives. The Company had a significant presence at Cure SMA\u2019s Annual SMA Conference and Annual SMA Research & Clinical Care Meeting, which was held June 23 \u2013 28, 2026 in Orlando, FL.\n<\/li>\n
- Scholar Rock engaging with European Medicines Agency (EMA)<\/b>on next steps for apitegromab Marketing Authorisation Application (MAA). <\/b>The EMA is reviewing the apitegromab MAA, which includes the Catalent Indiana fill-finish facility, and is awaiting the FDA inspection classification of Catalent Indiana. In parallel, Scholar Rock is engaging with the EMA on next steps, including the potential to add the Company\u2019s second fill-finish facility to the MAA. The Company plans to provide updated guidance on timelines for a Committee for Medicinal Products for Human Use (CHMP) opinion upon alignment with the EMA.\n<\/li>\n
- Continued robust enrollment in Phase 2 OPAL trial<\/b>. Enrollment and dosing in the Phase 2 OPAL study is ongoing (NCT07047144). The OPAL study is evaluating apitegromab in infants and toddlers with SMA under two years of age who have received an approved SMN1-targeted gene therapy or who are receiving ongoing treatment with an approved SMN2-targeted therapy.\n<\/li>\n
- Subcutaneous apitegromab progressing. <\/b>Scholar Rock has developed a high concentration subcutaneous formulation of apitegromab. The Company plans to engage with the FDA and EMA to align on the development path following the regulatory approvals of apitegromab for SMA.\n<\/li>\n<\/ul>\n
Facioscapulohumeral Muscular Dystrophy (FSHD) Program<\/b><\/p>\n
- \n
- Phase 2 FORGE trial initiated. <\/b>The Phase 2 randomized, double-blind, placebo-controlled trial, called FORGE, is expected to enroll approximately 60 patients with FSHD who will be randomized 1:1 to receive either apitegromab 10mg\/kg IV or placebo every 4 weeks for 52 weeks. The primary endpoint is mean lean muscle volume (LMV) change from baseline at 12 months. Secondary endpoints include safety, pharmacokinetics\/pharmacodynamics, and mean LMV change from baseline at 6 months. Several exploratory functional endpoints will also be assessed.\n<\/li>\n<\/ul>\n
SRK-439<\/span><\/b><\/p>\n
\nSRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that binds to pro- and latent myostatin with high affinity and selectivity. Based on preclinical data, SRK-439 has the potential to potently inhibit myostatin and increase muscle mass.<\/p>\n
- \n
- Phase 1 study in healthy volunteers ongoing. <\/b>A Phase 1 study evaluating SRK-439 in healthy volunteers is progressing well with topline data anticipated in late 2026.\n<\/li>\n<\/ul>\n
Second Quarter 2026 Financial Results<\/b><\/p>\n
\nScholar Rock reported a net loss of $109.9 million, including stock-based compensation of $19.7 million, for the quarter ended June 30, 2026, compared to a net loss of $110.0 million, including stock-based compensation of $24.4 million, for the quarter ended June 30, 2025. Net loss per common share was $0.84 for the quarter ended June 30, 2026, compared to $0.98 per common share for the quarter ended June 30, 2025.<\/p>\n
- \n
- \nThe Company did not record any revenue for the quarters ended June 30, 2026 and 2025.<\/p>\n<\/li>\n
- \nResearch and development expense was $58.2 million, including $7.5 million in stock-based compensation, for the quarter ended June 30, 2026, compared to $62.4 million, including $5.8 million in stock-based compensation, for the quarter ended June 30, 2025.<\/p>\n<\/li>\n
- \nGeneral and administrative expense was $50.7 million, including $12.2 million in stock-based compensation, for the quarter ended June 30, 2026, compared to $49.7 million, including $18.6 million in stock-based compensation, for the quarter ended June 30, 2025.<\/p>\n<\/li>\n
- \nAs of June 30, 2026, Scholar Rock had cash, cash equivalents, and marketable securities of $492.1 million. This reflects net cash proceeds of $62.8 million from the Company\u2019s at-the-market (ATM) program during the quarter ended June 30, 2026.<\/p>\n<\/li>\n<\/ul>\n
Conference Call Information<\/b><\/p>\n
\nScholar Rock will host a conference call and webcast today, Thursday, August 6, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent business updates. To access the live audio webcast, please go to \u201cEvents and Presentations\u201d in the Investors section of the Scholar Rock website at http:\/\/investors.scholarrock.com<\/a>.<\/p>\n
\nTo participate via telephone, please register in advance here<\/a>. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call.<\/p>\n
\nA replay of the webcast will be available on the Company\u2019s website for approximately 90 days.<\/p>\n
About Scholar Rock<\/b><\/p>\n
\nScholar 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 programs, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com<\/a> and follow @ScholarRock on X and on LinkedIn.<\/p>\n
\nScholar Rock\u00ae is a registered trademark of Scholar Rock, Inc.<\/p>\n
Availability of Other Information About Scholar Rock<\/b><\/p>\n
\n
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\n
\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n Scholar Rock Holding Corporation<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n Condensed Consolidated Balance Sheets<\/b><\/p>\n<\/td>\n<\/tr>\n
\n \n \n(unaudited)<\/p>\n<\/td>\n<\/tr>\n
\n \n \n(in thousands)<\/p>\n<\/td>\n<\/tr>\n
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\n \n\u00a0<\/p>\n<\/td>\n
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\n \n404,272<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n Liabilities and Stockholders’ Equity<\/b><\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nCurrent liabilities<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n72,242<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n55,419<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nLong-term liabilities<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n197,517<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n103,365<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal liabilities<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n269,759<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n158,784<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal stockholders’ equity<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n253,784<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n245,488<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n
\n \n \nTotal liabilities and stockholders’ equity<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n523,543<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n$<\/p>\n<\/td>\n
\n \n404,272<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n<\/tr>\n<\/table>\n
\n\u00a0<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260806667041\/en\/<\/a><\/span><\/p>\n
Investors
\n<\/b>
Laura Ekas, Ph.D.
\n
917-439-0374
\n
ir@scholarrock.com<\/a><\/p>\nMedia
\n<\/b>
Jeff Smith
\n
682-401-8428
\n
Molly MacLeod, Ph.D.
\n
802-579-5995
\n
media@scholarrock.com<\/a><\/p>\nKEYWORDS:<\/b> Massachusetts United States North America<\/p>\n
INDUSTRY KEYWORDS:<\/b> Medical Supplies Health FDA Neurology Genetics Clinical Trials Biotechnology<\/p>\n
- Phase 1 study in healthy volunteers ongoing. <\/b>A Phase 1 study evaluating SRK-439 in healthy volunteers is progressing well with topline data anticipated in late 2026.\n<\/li>\n<\/ul>\n
- U.S. Commercial team prepared to launch apitegromab upon FDA approval. <\/b>The U.S. Commercial team remains active in the field with SMA prescribers and centers of excellence nationwide, furthering disease education and awareness initiatives. The Company had a significant presence at Cure SMA\u2019s Annual SMA Conference and Annual SMA Research & Clinical Care Meeting, which was held June 23 \u2013 28, 2026 in Orlando, FL.\n<\/li>\n
- FDA review of second fill-finish facility progressing; Data package for FDA review of second fill-finish facility has been submitted; Ample supply available for commercialization upon FDA approval<\/i><\/li>\n
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<\/td>\n<\/tr>\n