SRRK - Earnings announcements

Scholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to 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 announced that management will present at the Goldman Sachs 47th Annual Global Healthcare Conference in Miami, FL on Tuesday, June 9, 2026 at 10:00 a.m. ET. A live webcast of the event will be available under the "Events and Presentations" page within the Investors section of the Scholar Rock website at http://investors.scholarrock.com. A replay of the webcast will be availabl

Scholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to 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 announced that management will present at the 2026 Jefferies Global Healthcare Conference in New York, NY on Wednesday, June 3, 2026 at 11:40 a.m. ET. A live webcast of the event will be available under the "Events and Presentations" page within the Investors section of the Scholar Rock website at http://investors.scholarrock.com. A replay of the webcast will be available for

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 38,481 shares of its common stock to six newly hired employees, consisting of inducement stock options to purchase an aggregate of 12,061 shares of common stock and inducement restricted stock units, covering an aggregate of 26,420 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used

FDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date Accepted apitegromab BLA includes two fill-finish facilities, Catalent Indiana LLC (part of Novo Nordisk), and a second U.S.-based facility FDA has completed reinspection of Catalent Indiana; classification of facility expected within 90 days following reinspection, in accordance with FDA guidelines Second fill-finish facility on track to have commercial apitegromab supply in early Q3 2026 Scholar Rock is prepared for U.S. apitegromab launch immediately upon FDA approval, w

Scholar Rock (NASDAQ:SRRK), a global biopharmaceutical company dedicated to 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 announced that management will present at the BofA Securities 2026 Health Care Conference in Las Vegas, NV, on May 12, 2026 at 8:00 a.m. PT / 11:00 a.m. ET. A live webcast of the event will be available under the "Events and Presentations" page within the Investors section of the Scholar Rock website at http://investors.scholarrock.com. A replay of the webcast will be availabl

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 89,304 shares of its common stock to nine newly hired employees, consisting of inducement stock options to purchase an aggregate of 38,331 shares of common stock and inducement restricted stock units, covering an aggregate of 50,973 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used

Scholar Rock (NASDAQ:SRRK) today announced that it will report first quarter 2026 financial results on Thursday, May 7, 2026, before the financial markets open. The Company will host a conference call and webcast with Scholar Rock management at 8:00 a.m. ET. To access the live audio webcast, please go to "Events and Presentations" in the Investors section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call. An archived replay of the webcast will be available on the Company's website for app

Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S.-based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock's alignment with FDA to resubmit apitegromab BLA prior to FDA reinspection of Catalent Indiana facility FDA and Scholar Rock Q1 2026 interactions regarding accelerated progress in qualifying a second fill-finish facility resulted in alignment with FDA to include facility in BLA resubmission Company anticipates FDA acceptance of BLA within 30 days and a review period of up to 6 months from date of resubmission, with PDUFA action date

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 60,655 shares of its common stock to five newly hired employees, consisting of inducement stock options to purchase an aggregate of 24,506 shares of common stock and inducement restricted stock units, covering an aggregate of 36,149 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used

Apitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA completed constructive meeting with Catalent Indiana, LLC (part of Novo Nordisk), with discussion of remediation progress and no additional corrective actions requested by FDA Scholar Rock plans to resubmit BLA upon successful FDA reinspection of Catalent Indiana Apitegromab Marketing Authorisation Application (MAA) review ongoing, with EMA decision anticipated in mid-2026; European launch expected in H2 2026, starting with Germany Secured new debt facility, providing up to $

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 announced that management will participate in the following investor conferences: TD Cowen 46th Annual Health Care Conference: Scholar Rock is scheduled to participate in a fireside chat at 1:50 p.m. ET on Wednesday, March 4, 2026 in Boston, MA Leerink Partners 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 2:

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the Company granted inducement equity awards covering an aggregate of 114,668 shares of its common stock to seven newly hired employees, consisting of inducement stock options to purchase an aggregate of 64,226 shares of common stock and inducement restricted stock units, covering an aggregate of 50,442 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is us

Scholar Rock (NASDAQ:SRRK) today announced that it will report fourth quarter and full year 2025 financial results on Tuesday, March 3, 2026, before the financial markets open. The Company will host a conference call and webcast with Scholar Rock management at 8:00 a.m. ET. To access the live audio webcast, please go to "Events and Presentations" in the Investors section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call. An archived replay of the webcast will be available on the Company's

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 35,200 shares of its common stock to two newly hired employees, consisting of inducement stock options to purchase an aggregate of 20,400 shares of common stock and inducement restricted stock units, covering an aggregate of 14,800 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used

Apitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA has scheduled meeting with Catalent Indiana, LLC (part of Novo Nordisk) in early 2026 to discuss progress of remediation efforts Apitegromab Investigational New Drug (IND) application cleared for facioscapulohumeral muscular dystrophy (FSHD); Phase 2 study initiation and patient dosing expected mid-2026 Subcutaneous apitegromab advancing; Phase 1 study demonstrated favorable bioavailability, with pharmacodynamic profile comparable to IV administration SRK-439 Phase 1 trial on

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 announced that management will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 7:30 a.m. PST (10:30 a.m. EST). A live webcast of the event will be available under the "Events and Presentations" page within the Investors section of the Scholar Rock website at http://investors.scholarrock.com. A replay of the webcast will be ava

Scholar Rock (NASDAQ:SRRK, the "Company")), today announced that the company granted inducement equity awards covering an aggregate of 7,800 shares of its common stock to two newly hired employees, consisting of inducement stock options to purchase an aggregate of 4,457 shares of common stock and inducement restricted stock units, covering an aggregate of 3,343 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used excl

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 announced that management will participate in the following investor conferences: Citi 2025 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 1:00 p.m. ET on Wednesday, December 3, 2025 in Miami, FL. 8th Annual Evercore Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:20 a.m. ET

Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA) Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection ready by the end of this year Resubmission of BLA and U.S. launch following approval of apitegromab for children and adults with SMA anticipated in 2026 Timelines accelerated with additional apitegromab U.S. fil

Scholar Rock (NASDAQ:SRRK, the "Company")) today announced that the company granted inducement equity awards covering an aggregate of 30,000 shares of its common stock to 1 newly hired employee, consisting of inducement stock options to purchase an aggregate of 17,143 shares of common stock and inducement restricted stock units, covering an aggregate of 12,857 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan") and the award agreements thereunder. The Plan, initially adopted by the Company's board of directors on June 16, 2022, and as amended from time to time, is used exc

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 announced that management will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference on Tuesday, November 18 at 3:30 p.m. GMT in London, UK. A live webcast of the event will be available under the "Events and Presentations" page within the Investors section of the Scholar Rock website at http://investors.scholarrock.com. A replay of the

Scholar Rock (NASDAQ:SRRK) today announced that it will report third quarter 2025 financial results on Friday, November 14, 2025, before the financial markets open. Following the release of the financials, the Company will host a live audio webcast with Scholar Rock management at 8:00 a.m. ET. To access the live audio webcast, please go to "Events and Presentations" in the Investors section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call. An archived replay of the webcast will be availabl

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases by applying its leading platform in myostatin biology to advance musculoskeletal health, today announced that the company granted inducement equity awards covering an aggregate of 114,500 shares of its common stock to 6 newly hired employees, consisting of inducement stock options to purchase an aggregate of 65,429 shares of common stock and inducement restricted stock units, covering an aggregate of 49,071 shares of its common stock. The a

No other approvability issues cited in CRL Scholar Rock intends to resubmit the apitegromab Biologics License Application (BLA) upon resolution of Catalent Indiana LLC-related observations 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 announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the apitegromab Biologics License Application (BLA) for the treat

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 120,800 shares of its common stock to 9 newly hired employees, consisting of inducement stock options to purchase an aggregate of 69,029 shares of common stock and inducement restricted stock units, covering an aggregate of 51,771 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Comp

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 426,250 shares of its common stock to 64 newly hired employees, consisting of inducement stock options to purchase an aggregate of 243,577 shares of common stock and inducement restricted stock units, covering an aggregate of 182,673 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the C

First and only muscle-targeted SMA therapy to demonstrate statistically significant, clinically meaningful improvements on the gold-standard HFMSE scale (p=0.019) versus placebo, with consistent benefits across pre-specified subgroups (age, type of SMN-targeted treatment, and SMN-targeted treatment initiation age) and region 30.4% of patients receiving apitegromab had ≥ 3-point improvement in HFMSE versus 12.5% of patients on placebo, despite all study patients receiving chronic, ongoing SMN-targeted treatment 19.6% of patients receiving apitegromab had ≥ 4-point improvement in their HFMSE score versus 6.3% of patients on placebo, despite all study patients receiving chronic, ongoing

FDA accepted the apitegromab BLA under priority review with a PDUFA target action of September 22, 2025; finalizing U.S. commercial launch preparations European Medicines Agency validated Marketing Authorisation Application (MAA), and regulatory process continues to progress; European launch anticipated in 2026 Positive topline results from Phase 2 EMBRAZE proof-of-concept trial in adult patients with obesity showed statistically significant preservation of lean mass with apitegromab during tirzepatide-induced weight loss Cash, cash equivalents and marketable securities of $295 million as of June 30, 2025; expected to support commercial and development programs into 2027 Ma

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that management will host a conference call to discuss its second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025, at 8:00am ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone,

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 224,100 shares of its common stock to 6 newly hired employees, consisting of inducement stock options to purchase an aggregate of 128,057 shares of common stock and inducement restricted stock units, covering an aggregate of 96,043 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022

Oral presentation on the positive Phase 3 SAPPHIRE trial of apitegromab for people living with spinal muscular atrophy (SMA), which demonstrated statistically significant improvement and clinically meaningful benefit as measured by the Hammersmith Functional Motor Scale Expanded (HFMSE) Apitegromab Biologics License Application (BLA) accepted under priority review for patients with SMA, and U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) date set for September 22 European Medicines Agency (EMA) validated Marketing Authorisation Application (MAA) for apitegromab for patients with SMA Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company f

Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus tirzepatide alone (p=0.001) Patients receiving apitegromab with tirzepatide over 24 weeks lost 18.8 lbs of fat mass while those on tirzepatide alone lost 17.7 lbs of fat mass Patients receiving apitegromab with tirzepatide over 24 weeks lost 12.3% of body weight while those on tirzepatide alone lost 13.4% of body weight Higher quality of weight loss observed for patients receiving apitegromab with tirzepatide (85% fat mass/15% lean mass) compared to tirzepatide alone (70% fat mass/30% lean mass) Apitegromab was generally well tolerated, and t

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 309,700 shares of its common stock to 11 newly hired employees, consisting of inducement stock options to purchase an aggregate of 176,963 shares of common stock and inducement restricted stock units, covering an aggregate of 132,737 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 20

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that David L. Hallal, Chief Executive Officer, and members of management will participate in a fireside chat at the 46th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 11 at 9:20 a.m. ET in Miami, Florida. A live webcast of the events may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. Archived replays of the webcasts will be available on the Company's websit

Rebecca McLeod brings exceptional U.S. operating experience; most recently served as argenx U.S. General Manager responsible for leading the launch of VYVGART® for gMG and CIDP Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that Rebecca McLeod has been appointed to the newly created role of Chief Brand Officer and U.S. General Manager. In this role, she will be responsible for leading the anticipated U.S. commercial launch of apitegromab for patients with SMA – along with establishing the globa

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that David L. Hallal, Chief Executive Officer, and members of the management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4 at 3:45 p.m. ET in New York City. A live webcast of the events may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. Archived replays of the webcasts will be available on the Company's website for app

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases, today announced that the company granted inducement equity awards covering an aggregate of 105,700 shares of its common stock to 14 newly hired employees, consisting of inducement stock options to purchase an aggregate of 60,400 shares of common stock and inducement restricted stock units, covering an aggregate of 45,300 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022

Apitegromab BLA accepted under priority review for patients with Spinal Muscular Atrophy (SMA) and FDA's PDUFA date set for September 22, 2025; commercial readiness progresses European Medicines Agency validated Marketing Authorisation Application (MAA) for apitegromab for patients with SMA Topline results from Phase 2 EMBRAZE proof-of-concept trial in adult patients with obesity on track for June 2025 Cash, cash equivalents and marketable securities of $364.4 million as of March 31, 2025; expected to support commercial and development programs into 2027 Management to host update call today at 8:15 a.m. ET Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company foc

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that management will host a conference call to discuss its first quarter 2025 financial results and provide a business update on Wednesday, May 14, 2025, at 8:15am ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Scholar Rock website at http://investors.scholarrock.com. To participate via telephone, please register in advance here. Upon

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the company granted inducement equity awards to R. Keith Woods, its newly named Chief Operating Officer and Vikas Sinha, its newly named Chief Financial Officer, covering an aggregate of up to 1,420,134 shares of its common stock, consisting of 110,067 stock options to purchase shares of common stock, 100,000 restricted stock units ("RSUs"), and up to 500,000 performance based restricted stock units ("PSUs") to each executive. The awards are subject to all terms a

David Hallal has served as Chairman of the Board of Directors since 2017; ensures seamless transition ahead of global launch of apitegromab for Spinal Muscular Atrophy Jay Backstrom, M.D., to serve as strategic advisor as part of planned transition, continuing to work closely with executive team and Board of Directors Akshay Vaishnaw, M.D., Ph.D., appointed to newly created role of President of R&D; has served as Board member since 2019 R. Keith Woods appointed to newly created role of Chief Operating Officer with focus on evolution to fully integrated global commercial operations Vikas Sinha appointed Chief Financial Officer Company to host Conference Call today at 8:30 AM ET

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the company granted inducement equity awards covering an aggregate of 156,650 shares of its common stock to 19 newly hired employees, consisting of inducement stock options to purchase an aggregate of 89,515 shares of common stock and inducement restricted stock units, covering an aggregate of 67,135 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth in the Company's 2022 Inducement Equity Plan (the "Plan"

Apitegromab remains on track to be the first and only muscle-targeted treatment for people living with Spinal Muscular Atrophy FDA to review BLA application under priority review, with a PDUFA date of September 22, 2025 Apitegromab Marketing Authorisation Application to the European Medicines Agency validated and under review Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted

Primary endpoint showed clinically meaningful improvement in patients with SMA receiving apitegromab as measured by gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo (p=0.0192), with consistent outcomes across all major sub-groups including age, SMN-targeted background therapy, and age at initiation of SMN-targeted therapy Pre-specified secondary endpoint showed that 30.4% of patients receiving apitegromab had ≥ 3-point improvement in HFMSE versus 12.5% of patients on placebo (nominal p-value = 0.0156), despite all study patients receiving ongoing SMN-targeted background therapy In other pre-specified secondary endpoints, patients with SMA receiving apite

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 113,800 shares of its common stock to seven newly hired employees, consisting of inducement stock options to purchase an aggregate of 65,027 shares of common stock and inducement restricted stock units, covering an aggregate of 48,773 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that management will participate in the following upcoming investor conferences: TD Cowen 45th Annual Health Care Conference: Scholar Rock is scheduled to participate in a fireside chat at 2:30 p.m. ET on Tuesday, March 4 in Boston. Wedbush Cardiometabolic Conference: Scholar Rock is scheduled to participate in a panel presentation at 10:05 a.m. ET on Monday, March 10 in Miami. Jefferies Biotech on the Bay Summit: Sch

Oral presentation to include additional efficacy data from the Phase 3 SAPPHIRE trial of apitegromab in patients with spinal muscular atrophy (SMA) Poster presentations include preclinical data on a combination treatment approach for building muscle mass and strength in a Duchenne muscular dystrophy (DMD) model Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, announced today that it will present additional data from its Phase 3 SAPPHIRE clinical trial (NCT05156320) at the 2025 Muscular

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 371,500 shares of its common stock to eleven newly hired employees, consisting of inducement stock options to purchase an aggregate of 212,284 shares of common stock and inducement restricted stock units, covering an aggregate of 159,216 shares of its common stock. The awards are subject to all terms and conditions and other provisions set f

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that management will host a conference call to discuss its fourth quarter and full year 2024 financial results and provide a business update on Thursday, February 27, 2025, at 8:15am ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Scholar Rock website at http://investors.schol

Scholar Rock's BLA submission is based on the Phase 3 SAPPHIRE trial that demonstrated a statistically significant improvement in motor function for patients receiving apitegromab compared to placebo, as measured by the Hammersmith Functional Motor Scale-Expanded at week 52 The FDA has granted apitegromab Fast Track, Orphan Drug and Rare Pediatric Disease Designations in SMA Scholar Rock remains on track to submit the apitegromab Marketing Authorisation Application (MAA) to the European Medicines Agency in 1Q 2025, with PRIME and Orphan Medicinal Product Designations Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for s

- Lisa Wyman brings more than 20 years of leadership and functional experience to new role of Chief Technical and Quality Officer on the Executive Team at Scholar Rock - Ted Myles, Chief Operating Officer & Chief Financial Officer, will continue to operate through transition phase to a new organizational structure Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, announced today that Lisa Wyman has been appointed to the new role of Chief Technical and Quality Officer (CTQO) to support th

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 48,000 shares of its common stock to three newly hired employees, consisting of inducement stock options to purchase an aggregate of 27,429 shares of common stock and inducement restricted stock units, covering an aggregate of 20,571 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that management will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 9:45 a.m. PT (12:45 p.m. ET). A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcast will be available on the Company's website for approximately 90 days. About Scholar Rock

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 208,800 shares of its common stock to twelve newly hired employees, consisting of inducement stock options to purchase an aggregate of 119,312 shares of common stock and inducement restricted stock units, covering an aggregate of 89,488 shares of its common stock. The awards are subject to all terms and conditions and other provisions set fo

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 100,500 shares of its common stock to four newly hired employees, consisting of inducement stock options to purchase an aggregate of 57,429 shares of common stock and inducement restricted stock units, covering an aggregate of 43,071 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth

- Preclinical data show that SRK-439 increased lean mass and lowered fat mass gain in mice receiving metformin - Data support that Scholar Rock's unique approach to selective myostatin inhibition could improve body composition in people living with obesity and on an existing background treatment - Scholar Rock's industry-leading anti-myostatin portfolio includes SRK-439 and apitegromab, the first investigational anti-myostatin therapy to show improved motor function in Spinal Muscular Atrophy (SMA) in a Phase 3 trial - Obesity program progressing with Phase 2 EMBRAZE trial on track for readout in Q2 2025 Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advan

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that management will host a conference call to discuss its third quarter 2024 financial results and provide a business update on Tuesday, November 12, 2024, at 8:15am ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Scholar Rock website at http://investors.scholarrock.com. To pa

Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that management will participate in the following upcoming investor conferences: Truist Securities BioPharma Symposium: Scholar Rock is scheduled to participate in a panel presentation at 3:25 p.m. ET on Thursday, November 7 in New York City. Jefferies London Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 4:30 p.m. GMT on Wednesday, November 20 in London. Piper Sandler 36th Annual H

Poster presentation to include new safety, efficacy, and biomarker data from the long-term expansion phase of the DRAGON trial in patients with advanced solid tumors treated with SRK-181 Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, announced today that it will present data from the Phase 1 DRAGON trial of SRK-181, an investigational selective inhibitor of latent TGFβ1 activation, in patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meet

Scholar Rock (NASDAQ:SRRK, the "Company"))), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 23,500 shares of its common stock to two newly hired employees, consisting of inducement stock options to purchase an aggregate of 13,429 shares of common stock and inducement restricted stock units, covering an aggregate of 10,071 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth i