Highest-materiality recent filing
Scholar Rock reports Q1 net loss $105.5M; FDA accepts apitegromab BLA with Sep 30 PDUFA
FDA accepted apitegromab BLA for SMA; PDUFA action date Sep 30, 2026; two fill-finish facilities included.
Scholar Rock resubmits BLA for apitegromab SMA; PDUFA goal late Sept 2026
Resubmission follows Sep 2025 CRL related to Catalent Indiana facility; no other approvability concerns cited.
Q4 2025 net loss of $91.0M ($0.76 per share, corrected); FY2025 net loss $377.9M ($3.29 per share), up from $246.3M in 2024.
Scholar Rock reports FY2025 net loss $378M; BLA resubmission expected in 2026 after FDA reinspection
Net loss $377.9M for 2025 ($3.29 per share) vs $246.3M in 2024; no revenue; cash $367.6M at Dec 31.
Scholar Rock provides 2026 priorities; ~$365M cash; apitegromab BLA resubmission expected in 2026
Preliminary cash of ~$365M as of Dec 31, 2025; expected runway into 2027.
Catalent Indiana (Novo Nordisk) received FDA Warning Letter for facility with 'official action indicated' classification.
Net loss $102.2M (EPS -$0.90) vs $64.5M (EPS -$0.66) YoY; no revenue.
Scholar Rock expands ATM equity offering by up to $200M
Filed prospectus supplement to sell up to $200,000,000 of common stock via ATM program through Jefferies LLC.
Scholar Rock notified that FDA classifies Catalent Indiana facility as 'official action indicated'
Novo Nordisk informed Scholar Rock on Oct 10 that FDA classified Catalent Indiana (owned by Novo Nordisk) as 'official action indicated' (OAI).
FDA issues CRL for Scholar Rock's apitegromab BLA due to Catalent fill-finish observations
CRL cites observations at Catalent Indiana fill-finish facility; no efficacy/safety issues.
Scholar Rock Q2 loss $110M; apitegromab PDUFA Sept 22, 2025; positive EMBRAZE lean mass data
FDA accepted apitegromab BLA under priority review; PDUFA target action date September 22, 2025.
Primary endpoint met: apitegromab + tirzepatide preserved 54.9% of lean mass (p=0.001) vs tirzepatide alone over 24 weeks.
Scholar Rock Q1 net loss $74.7M; BLA priority review set for Sept 22, 2025; cash to 2027
Net loss $74.7M ($0.67 per share) vs $56.9M in Q1 2024; no revenue.
Scholar Rock appoints David Hallal as CEO; adds new President of R&D, COO, and CFO
David Hallal (formerly Chairman) becomes CEO effective April 27, 2025; Jay Backstrom transitions to Senior Advisor through Oct 31.
Scholar Rock reports FY 2024 net loss of $2.47/share; BLA submitted for apitegromab in SMA
Net loss $246.3M ( $2.47 /share) vs $165.8M ( $1.99 /share) in FY 2023; zero revenue.
Scholar Rock appoints Lisa Wyman as CTQO; COO role eliminated, CFO search begins
Lisa Wyman appointed Chief Technical & Quality Officer effective Jan 27, 2025, reporting to CEO.
Scholar Rock Phase 3 SAPPHIRE trial meets primary endpoint; Q3 net loss $64.5M
Phase 3 SAPPHIRE achieved primary endpoint: apitegromab 1.8-point HFMSE improvement (p=0.0192) vs placebo.
Scholar Rock prices $300M upsized public offering of common stock and pre-funded warrants
Gross proceeds ~$300M; 10,265,488 shares at $28.25/share and 353,983 pre-funded warrants at $28.2499 each.
Apitegromab meets Phase 3 primary endpoint in SMA; Scholar Rock plans BLA/MAA filing Q1 2025
Primary endpoint met: apitegromab improved HFMSE vs placebo (mean diff 1.8 points, p=0.0192) in patients ages 2-12.
Scholar Rock Q2 net loss $0.60/shr; cash $190.5M; Phase 3 SAPPHIRE data on track Q4 2024
Net loss $58.5M ($0.60/shr) vs $37.9M ($0.47/shr) in Q2 2023; no revenue.
Preclinical DIO mouse study: SRK-439 with semaglutide preserved lean mass (26.4g vs 22.3g at 4 weeks, p<0.001) and increased relative lean mass (65.8%) after semaglutide withdrawal vs control (57.1%).
Scholar Rock reports positive SRK-181 Phase 1 data across multiple tumors; ccRCC ORR 23.3%
SRK-181 + pembrolizumab showed ORR 23.3% in ccRCC, 27.3% in melanoma, 18.2% in HNSCC, 9.1% in UC; no NSCLC response.
Phase 2 EMBRAZE proof-of-concept trial initiated for apitegromab in obesity, targeting 100 subjects on GLP-1 RA; primary data expected mid-2025.
Scholar Rock Q1 net loss $56.9M ($0.59/shr); Phase 3 SMA data on track for Q4 2024
Net loss $56.9M ($0.59/shr) vs $39.4M ($0.49) Q1 2023; no revenue; R&D up 45% to $43.1M.
Scholar Rock reports FY2023 net loss of $165.8M; cash $280M; SAPPHIRE data expected 4Q 2024
Net loss $165.8M ($1.99/share) vs $134.5M ($2.26/share) in FY2022; no revenue vs $33.2M prior year.
appointed Mr. David Hallal as Chief Executive Officer of the Company effective as of April 27, 2025
Dr. Jay T. Backstrom’s transition from his role as the Company’s Chief Executive Officer and President to Senior Advisor on the Transition Date.
appointed Akshay Vaishnaw, a current member of the Board, as the Company’s President of Research & Development
Dr. Backstrom also resigned as a member of the Board on the Transition Date.
In connection with the previously announced departure of Edward Myles as Scholar Rock Holding Corporation’s (the “Company”) Chief Operating Officer and Chief Financial Officer on March 15, 2025
the Board of Directors (the “Board”) of the Company appointed Erin Moore, Senior Vice President, Finance, as the Company’s interim Principal Financial Officer and interim Principal Accounting Officer, effective March 21, 2025.
announced the appointment of Lisa Wyman, as Chief Technical and Quality Officer of the Company, effective January 27, 2025
On February 15, 2024, Amir Nashat informed the Company that he will not stand for reelection as a Class II director at the Company’s annual meeting of stockholders in 2024
subsequently appointed Katie Peng to join the Board, effective February 15, 2024, filling the vacancy created by the increase in the size of the Board.
Max materiality 0.90 · Median 0.70 · Most common event other_material