Scholar Rock Holding Corp (SRRK) Scholar Rock Holding Corporation is a biopharmaceutical firm dedicated to discovering and advancing treatments for severe medical conditions by targeting the crucial role of protein growth factor signaling. Their lead therapeutic candidate, Apitegromab, an agent designed to inhibit the activation of latent myostatin, has successfully concluded Phase 3 clinical trials for spinal muscular atrophy (SMA). Another key program, SRK-181, is currently undergoing Phase 1 clinical assessment for tackling cancers that exhibit resistance to established checkpoint inhibitor treatments, including anti-PD-1 or anti-PD-L1 antibody therapies. Beyond these, the company cultivates a robust pipeline of innovative potential therapies, aiming to significantly improve the lives of individuals grappling with various severe ailments, such as neurological muscle conditions, malignancies, and fibrotic disorders. In a strategic partnership, Scholar Rock is collaborating with Gilead Sciences, Inc. to identify and develop targeted inhibitors of transforming growth factor beta (TGF-beta) activation, specifically for addressing fibrotic diseases. Established in 2012, Scholar Rock Holding Corporation operates from its headquarters in Cambridge, Massachusetts.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Scholar Rock Holding Corporation NASDAQ:SRRK Healthcare · Biotechnology
Mkt Cap $5.35B
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release
Scholar Rock to Report Third Quarter 2026 Financial Results on November 10, 2026
Scholar Rock announced it will report third quarter 2026 financial results on Tuesday, November 10, 2026, before market open.
Management will host a conference call and webcast at 8:00 a.m. ET the same day, with an archived replay available for approximately 90 days.
The release contains no results or guidance; context notes Scholar Rock is commercializing ISEMBLYD (apitegromab-mstn) in the U.S. following September 2026 FDA approval.
• 12d ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted inducement equity awards covering 61,020 shares to seven newly hired employees under its 2022 Inducement Equity Plan.
The grants comprise options for 17,461 shares at a $41.94 exercise price (the October 12, 2026 close) and RSUs for 43,559 shares, with standard four-year vesting.
This is a routine Nasdaq Rule 5635(c)(4) hiring disclosure with no financial or strategic impact.
• 16d ago AI analysis › Press Release ⚠ 2
Scholar Rock Resubmits Apitegromab Marketing Authorisation Application (MAA) to European Medicines Agency (EMA) for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)
Scholar Rock resubmitted the Marketing Authorisation Application for apitegromab to the EMA for treatment of children and adults with spinal muscular atrophy.
The resubmission replaces the Catalent Indiana fill-finish facility, which had GMP compliance issues, with an alternate U.S.-based site that supported the September 2026 FDA approval of ISEMBYLD; a CHMP opinion is anticipated in H1 2027.
Vials are already on site at a third-party provider awaiting packaging and labeling, positioning the company for a rapid European launch if approved.
• 24d ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted inducement equity awards covering an aggregate of 83,102 shares of common stock to ten newly hired employees under its 2022 Inducement Equity Plan.
The awards consist of stock options to purchase 23,801 shares at an exercise price of $51.85 (the September 14, 2026 close) plus 59,301 inducement RSUs; options vest 25% on the first anniversary of hire with the remainder in quarterly installments, while RSUs vest in four equal annual installments.
This is a routine Nasdaq Listing Rule 5635(c)(4) disclosure with negligible dilution and no bearing on the company's ongoing commercialization of ISEMBYLD in spinal muscular atrophy.
• 1mo ago AI analysis › Press Release ● Critical ⚠ 3
Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)
Scholar Rock won FDA approval for ISEMBYLD (apitegromab-mstn), the first and only muscle-targeted treatment for spinal muscular atrophy, covering adults and children 2 years and older already receiving an SMN2-targeted therapy.
Approval was based on the Phase 3 SAPPHIRE study, which showed a 2.2-point HFMSE improvement versus placebo at one year (nominal p=0.0121), with 34.2% of treated patients gaining 3 or more points versus 13.5% on placebo (odds ratio 3.8).
The U.S. commercial launch is already underway with product shipping in the coming days, and the company was awarded a Rare Pediatric Disease Priority Review Voucher alongside the approval.
The label carries a fracture risk -- 9% of patients on the recommended 10 mg/kg dose versus 2% on placebo -- and management hosts an investor call on Monday, September 14, 2026 at 8:00 a.m. ET.
• 1mo ago AI analysis › Press Release ⚠ 3
Scholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial
The FDA granted Fast Track and Orphan Drug designations to Scholar Rock's apitegromab for facioscapulohumeral muscular dystrophy, and participant dosing is now underway in the Phase 2 FORGE trial.
FORGE will enroll approximately 60 adults with genetically confirmed FSHD, randomized 1:1 to apitegromab 10 mg/kg or placebo intravenously every four weeks for 52 weeks, with percent change in total lean muscle volume by MRI at Week 52 as the primary endpoint.
Apitegromab is the first and only muscle-targeted therapy to show statistically significant and clinically meaningful motor function improvement in a Phase 3 SMA study, while FSHD currently has no approved therapies and affects an estimated 40,000 people across the US and EU.
Fast Track is intended to expedite development and review, making FSHD a second rare-disease opportunity for Scholar Rock's myostatin platform, though clinical data remain years away.
• 1mo ago AI analysis › Press Release
Scholar Rock to Present at Upcoming Investor Conferences
Scholar Rock announced that management will present at two upcoming investor conferences in New York during September 2026.
The company is scheduled to participate in fireside chats at the Cantor 2026 Global Healthcare Conference on September 9 and the Citi 2026 BioPharma Back to School Conference on September 10.
Live webcasts and subsequent replays of the presentations will be available on the Investors section of the Scholar Rock website.
• 2mo ago AI analysis › Press Release ● Major
Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan
Scholar Rock successfully removed Catalent Indiana from its U.S. apitegromab BLA under FDA guidance, with the agency confirming review is progressing well using an alternate fill-finish facility.
The company also withdrew its European MAA to resubmit with the new facility, while securing PMDA alignment in Japan to submit a JNDA by year-end 2026 without additional local clinical data.
Management confirmed readiness for an immediate U.S. launch upon FDA approval, which is expected by the September 30, 2026 PDUFA date.
• 2mo ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted inducement equity awards covering 51,947 shares to twelve new employees under Nasdaq Rule 5635(c)(4).
The grants include options to purchase 14,889 shares at $51.89 and restricted stock units covering 37,058 shares.
The options vest over four years with a one-year cliff, while RSUs vest in four equal annual installments.
• 2mo ago AI analysis › Press Release ⚠ 2
Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date
Scholar Rock will remove the Catalent Indiana fill-finish facility from the apitegromab BLA after the FDA classified an April site inspection as Official Action Indicated (OAI).
The company will proceed with a second fill-finish facility, having submitted the required data package ahead of schedule, and confirmed that the FDA PDUFA action date remains September 30, 2026.
Commercial supply from the second facility is ready and awaiting packaging, while the company engages with the EMA to update its Marketing Authorisation Application.
• 2mo ago AI analysis › Press Release ● Major ⚠ 2
Scholar Rock Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Scholar Rock reported Q2 2026 financial results alongside a critical update on its lead asset apitegromab, which remains on track for a potential FDA approval by the September 30, 2026 PDUFA date.
The company advanced the BLA review with two independent fill-finish facilities, securing ample supply for commercialization, while the Catalent Indiana inspection classification remains pending.
Financial results showed a net loss of $0.84 per share, but the balance sheet remains robust with $492.1 million in cash, strengthened by $62.8 million in ATM proceeds during the quarter.
• 2mo ago AI analysis › Press Release
Scholar Rock to Present at the Canaccord Genuity 46th Annual Growth Conference
Scholar Rock management is scheduled to present at the Canaccord Genuity 46th Annual Growth Conference in Boston on August 12, 2026 at 1:30 p.m. ET.
A live webcast of the presentation will be available on the company's website, with a replay accessible for approximately 90 days following the event.
The company is a late-stage biopharmaceutical firm focused on developing and commercializing apitegromab for spinal muscular atrophy and other rare neuromuscular diseases.
• 3mo ago AI analysis › Press Release ⚠ 2
Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)
Scholar Rock announced that the CHMP opinion for apitegromab will not be issued at the current July meeting, as it awaits the FDA's inspection classification of the Catalent Indiana fill-finish facility.
If the Catalent facility is not reclassified by the FDA, the company intends to pivot to a second, U.S.-based fill-finish facility to advance the European MAA.
The U.S. PDUFA date remains September 30, 2026, and management plans to provide a further update on the regulatory situation during the Q2 earnings call on August 6.
• 3mo ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted inducement equity awards covering an aggregate of 118,586 shares of common stock to eleven newly hired employees.
The awards consist of stock options to purchase 33,987 shares and restricted stock units covering 84,599 shares, granted under Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $54.70 per share and will vest over a four-year period following the employees' start dates.
• 3mo ago AI analysis › Press Release
Scholar Rock to Report Second Quarter 2026 Financial Results on August 6, 2026
Scholar Rock announced that it will report its second quarter 2026 financial results before the market opens on August 6, 2026.
The company plans to host a conference call and webcast at 8:00 a.m. ET on the same day to review the quarterly performance.
Scholar Rock is a biopharmaceutical company focused on developing apitegromab and other treatments for rare neuromuscular diseases.
• 3mo ago AI analysis › Press Release
Scholar Rock to Showcase Neuromuscular Research Portfolio at 2026 Annual Cure SMA Research and Clinical Care Meeting and 2026 International Research Congress on FSHD
Scholar Rock announced it will present updates on its neuromuscular portfolio at the upcoming Cure SMA and FSHD Society conferences in late June.
Presentations will include post hoc analyses from the Phase 3 SAPPHIRE trial of apitegromab in SMA and design details for the Phase 2 FORGE study in FSHD.
Apitegromab is an investigational monoclonal antibody inhibiting myostatin activation and is the company's lead candidate.
• 4mo ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted 134,345 shares of inducement equity awards to 11 newly hired employees.
The grants consist of 50,936 stock options and 83,409 restricted stock units under the company’s 2022 Inducement Equity Plan.
Options were priced at $43.80, matching the June 8 closing price, with standard vesting schedules tied to continued service.
• 4mo ago AI analysis › Press Release
Scholar Rock to Present at the Goldman Sachs 47th Annual Global Healthcare Conference
businesswire.com • 5mo ago Press Release
Scholar Rock to Present at the 2026 Jefferies Global Healthcare Conference
Scholar Rock announced that management will present at the 2026 Jefferies Global Healthcare Conference.
The presentation is scheduled for Wednesday, June 3, 2026, at 11:40 a.m. ET in New York.
A live webcast and replay will be available on the company's investor relations website.
• 5mo ago AI analysis › Press Release
Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Scholar Rock granted inducement equity awards covering 38,481 shares to six newly hired employees.
The grants consist of 12,061 stock options with an exercise price of $48.35 and 26,420 restricted stock units.
These awards are issued under the company’s 2022 Inducement Equity Plan in compliance with Nasdaq Listing Rule 5635(c)(4).
• 5mo ago AI analysis › Press Release ● Major ⚠ 2
Scholar Rock Reports First Quarter 2026 Financial Results and Recent Business Highlights
Scholar Rock announced that the FDA accepted the BLA for apitegromab with a PDUFA action date of September 30, 2026, bringing the company closer to launching the first muscle-targeted treatment for SMA.
The company reported Q1 cash and marketable securities of $479.9 million, bolstered by a $100 million debt drawdown and $98 million in ATM proceeds during the quarter.
Net loss widened to $105.5 million, driven by increased R&D and G&A expenses, though management emphasized readiness for the upcoming commercial launch.
• 5mo ago AI analysis › Press Release
Scholar Rock to Present at the BofA Securities 2026 Health Care Conference
Scholar Rock announced that management will present at the upcoming BofA Securities 2026 Health Care Conference in Las Vegas.
The presentation is scheduled for May 12, 2026, at 8:00 a.m. PT, with a live webcast available on the company's investor relations website.
A replay of the event will be archived and accessible for approximately 90 days following the conference.
• 6mo ago AI analysis › 
