Earnings summaries and quarterly performance for Scholar Rock Holding.
Executive leadership at Scholar Rock Holding.
David Hallal
Detailed
Chief Executive Officer
CEO
AV
Akshay Vaishnaw
Detailed
President of R&D
BS
Beth Shafer
Detailed
Chief Business Officer
JM
Jing Marantz
Detailed
Chief Medical Officer
JH
Junlin Ho
Detailed
General Counsel & Corporate Secretary
KW
Keith Woods
Detailed
Chief Operating Officer
LW
Lisa Wyman
Detailed
Chief Technical & Quality Officer
MQ
Mo Qatanani
Detailed
Chief Scientific Officer
TS
Tracey Sacco
Detailed
Chief Commercial Officer
VS
Vikas Sinha
Detailed
Chief Financial Officer
Board of directors at Scholar Rock Holding.
Research analysts who have asked questions during Scholar Rock Holding earnings calls.
KD
Kripa Devarakonda
Truist Securities
5 questions for SRRK
Also covers: ABCL, ARVN, BMY +5 more
MF
Marc Frahm
TD Cowen
5 questions for SRRK
Also covers: ADAP, AGIO, BPMC +7 more
Tessa Romero
JPMorgan Chase & Co.
5 questions for SRRK
Also covers: ACAD, AGIO, CYTK +5 more
Allison Bratzel
Piper Sandler Companies
3 questions for SRRK
Also covers: ABCL, AKBA, ALXO +5 more
ES
Eric Schmidt
Cantor Fitzgerald & Co.
3 questions for SRRK
Also covers: ADCT, AGIO, BIIB +9 more
ES
Evan Seigerman
BMO Capital Markets
3 questions for SRRK
Also covers: ABBV, AMGN, ARVN +15 more
Gary Nachman
Raymond James
3 questions for SRRK
Also covers: ABBV, ACHV, ADMA +9 more
Michael Yee
Jefferies
3 questions for SRRK
Also covers: ALLO, AMGN, BEAM +14 more
David Nierengarten
Wedbush Securities
2 questions for SRRK
Also covers: ARGX, ITOS, KNSA +4 more
ED
Edsur Dara
Barclays
2 questions for SRRK
MF
Mani Foroohar
Leerink Partners
2 questions for SRRK
Also covers: ADVM, ALNY, ARWR +9 more
TA
Tazeen Ahmad
Bank of America
2 questions for SRRK
Also covers: ACAD, ALNY, APLS +20 more
Andres Maldonado
H.C. Wainwright & Co.
1 question for SRRK
Also covers: DAWN, IMAB
Dennis Kennedy
LifeSci Capital
1 question for SRRK
ED
Etzer Darout
BMO Capital Markets
1 question for SRRK
Also covers: ARVN, CTMX, EXEL +5 more
MH
Malcolm Hoffman
BMO Capital Markets
1 question for SRRK
Also covers: ABCL, ACAD, BNTX +1 more
SD
Srikripa Devarakonda
Truist Financial Corporation
1 question for SRRK
Also covers: ABCL, ABSI, AFMD +12 more
Thomas Deal
Raymond James
1 question for SRRK
Recent press releases and 8-K filings for SRRK.
Scholar Rock Reviews 2025 Milestones and Apitegromab Regulatory Update
SRRK
Guidance Update
Management Change
Product Launch
- Scholar Rock's Apitegromab for spinal muscular atrophy (SMA) achieved a positive Phase 3 Sapphire study readout in Q4 2024, leading to a BLA filing in January 2025 and priority review acceptance in April 2025.
- In April 2025, David Hallal assumed the CEO role, bringing in a new executive team to focus on scale and growth, including Vikas Sinha as CFO, Keith Woods as COO, and Akshay Vaishnaw as Head of R&D.
- The company received a Complete Response Letter (CRL) for Apitegromab on September 22, 2025, solely due to a manufacturing issue at the fill/finish facility (Catalent, Indiana), with efficacy and safety not being concerns.
- Following a Type A FDA meeting in November 2025, Scholar Rock expects resubmission and U.S. launch in 2026, with the delay providing additional time for launch preparation, payer discussions, and community engagement.
Dec 4, 2025, 1:20 PM
Scholar Rock Discusses Apitegromab Regulatory Path and Commercial Strategy
SRRK
Product Launch
Management Change
Guidance Update
- Scholar Rock's apitegromab for spinal muscular atrophy (SMA) achieved positive pivotal Phase 3 Sapphire study results in Q4 2024, leading to a BLA filing and priority review acceptance by the FDA in early 2025.
- In April 2025, David Hallal became CEO, bringing in a new executive team including a CFO, COO, and Head of R&D, to focus on scale and growth towards commercialization.
- The FDA issued a Complete Response Letter (CRL) for apitegromab's BLA in September 2025, solely due to non-compliance at the Catalent (now Novo Nordisk) fill/finish facility, with no issues regarding the product's efficacy or safety.
- Following a constructive Type A meeting with the FDA in November 2025, Scholar Rock expects to resubmit the BLA and launch in the U.S. in 2026.
- The company expresses confidence in broad payer coverage for apitegromab as an add-on therapy, citing strong data showing motor function gain and a modest budget impact due to the limited patient population.
Dec 4, 2025, 1:20 PM
Scholar Rock Provides Update on Apitegromab FDA Review and 2026 Launch Plans
SRRK
Product Launch
Guidance Update
New Projects/Investments
- Scholar Rock received a Complete Response Letter (CRL) from the FDA on September 22, 2025, for apitegromab's Biologics License Application (BLA) due to manufacturing issues at its drug product facility. The company expects to resubmit and launch in the U.S. in 2026.
- Apitegromab, a muscle-targeted treatment for Spinal Muscular Atrophy (SMA), demonstrated statistically significant and clinically meaningful improvement in motor function in its Phase III trial when used with SMN-targeted treatments.
- The company projects a global market of approximately 35,000 SMA patients who have received SMN-targeted treatments, with a potential for over $2 billion in annual revenue for apitegromab in SMA alone.
- Scholar Rock reported a cash balance of $369 million as of its Q3 call, providing a runway into 2027, and is exploring expanding its loan facility and monetizing a Priority Review Voucher (PRV) to support the launch.
- The pipeline includes plans to announce the next indication for apitegromab in early 2026 and the initiation of dosing healthy volunteers for SRK-439, a next-generation myostatin inhibitor, in December 2025.
Dec 3, 2025, 6:00 PM
Scholar Rock Provides Update on Apitegromab CRL, Leadership, and Financial Outlook
SRRK
Guidance Update
Management Change
Product Launch
- Scholar Rock received a Complete Response Letter (CRL) from the FDA on September 22, 2025, for apitegromab, due to issues at the drug product manufacturer. The company expects to resubmit and launch in the U.S. in 2026.
- The company recently appointed a new executive team, including David Hallal as CEO and Vikas Sinha as CFO, to lead its strategy of building a global biotech company.
- Scholar Rock projects a substantial market for apitegromab in SMA, targeting 7,000 U.S. patients and 35,000 global patients who have received SMN-targeted treatments, anticipating a multi-billion dollar opportunity and over $2 billion in annual revenue for apitegromab in SMA alone.
- The company reported a $369 million cash balance in Q3, is expanding its loan facility, and plans to monetize Priority Review Vouchers (PRVs) to fund operations through the anticipated 2026 U.S. launch and beyond.
- Scholar Rock is progressing its pipeline, with plans to announce the next indication for apitegromab in early 2026 and initiating dosing of healthy volunteers for SRK-439 in December 2025.
Dec 3, 2025, 6:00 PM
Scholar Rock Provides Update on Apitegromab Launch Timeline, Market Opportunity, and Financial Position
SRRK
CEO Change
CFO Change
Guidance Update
- David Hallal assumed the role of CEO and Vikas Sinha became CFO in April 2025, following the positive Phase III trial readout for apitegromab in October 2024.
- Scholar Rock received a Complete Response Letter (CRL) for apitegromab on September 22, 2025, from the FDA, citing manufacturing issues at the drug product facility (Catalent/Novo Nordisk) as the sole remaining issue.
- Following a Type A meeting with the FDA and Novo Nordisk on November 12, 2025, and a subsequent warning letter, Scholar Rock maintains its guidance for a U.S. resubmission and launch of apitegromab in 2026.
- Apitegromab is positioned as the first muscle-targeted treatment for Spinal Muscular Atrophy (SMA), addressing a multi-billion dollar global opportunity with an estimated 7,000 patients in the U.S. and 35,000 globally who have received SMN-targeted therapies.
- As of Q3 2025, Scholar Rock reported $369 million in cash, which is expected to fund operations into 2027, with plans to expand loan facilities and monetize Priority Review Vouchers (PRVs).
Dec 3, 2025, 6:00 PM
Scholar Rock Provides Update on Apitegromab Approval Timeline and Financial Runway
SRRK
Product Launch
Guidance Update
New Projects/Investments
- Scholar Rock received a Complete Response Letter (CRL) for apitegromab's BLA due to compliance issues at its GMP manufacturing fill finish facility, Novo Nordisk in Bloomington, Indiana.
- Novo Nordisk has a robust remediation plan, with approximately 90% of the remediation complete, including all critical items from the 483. The FDA intends to communicate with Novo before the end of 2025 regarding their progress, and a reinspection is expected in the new year (2026).
- If the Official Action Indicated (OAI) notice is resolved at the manufacturing site, Scholar Rock believes apitegromab could be approved in 2026.
- Scholar Rock is also developing a backup U.S. manufacturing facility, with tech transfer initiated and a supplemental BLA for this site anticipated by the end of 2026.
- The company's cash runway extends into 2027, supported by $369.6 million in cash at the end of Q3, additional funding, and assuming zero apitegromab revenue.
Nov 18, 2025, 3:30 PM
Scholar Rock Provides Update on Apitegromab Regulatory Path and Financials
SRRK
Product Launch
Guidance Update
New Projects/Investments
- Scholar Rock received a Complete Response Letter (CRL) for apitegromab in September 2022 due to compliance issues at its GMP manufacturing facility, Novo Nordisk in Bloomington, Indiana, which subsequently received an Official Action Indicated (OAI) notice.
- Following a Type A meeting with the FDA, Novo Nordisk has a robust remediation plan, with up to 90% of the remediation complete for the manufacturing site. The FDA is expected to communicate with Novo by the end of 2025, with a reinspection anticipated in the new year (2026), potentially leading to apitegromab approval in 2026.
- Scholar Rock is also developing a backup U.S. manufacturing facility, with a supplemental BLA (SBLA) for this site anticipated within 2026.
- The company reported $369.6 million in cash at the end of Q3, with additional funding expected in Q4, extending its cash runway into 2027, assuming no apitegromab revenue.
Nov 18, 2025, 3:30 PM
SRRK Provides Ipilimumab Approval Timeline and Manufacturing Update
SRRK
Product Launch
New Projects/Investments
Guidance Update
- ScholarRock (SRRK) received a Complete Response Letter (CRL) for ipilimumab due to compliance issues at its GMP manufacturing fill-finish facility, Novo Catalent, which subsequently received an Official Action Indicated (OAI) notice.
- Following a Type A meeting with the FDA, Novo Catalent has completed approximately 90% of its remediation plan, including all critical items, and the FDA is expected to communicate with Novo before the end of 2025 regarding the progress.
- The FDA has committed to reinspect the Novo Catalent facility in the New Year (2026), and ScholarRock believes ipilimumab could be approved in 2026 after the OAI is resolved and the BLA is resubmitted.
- ScholarRock is accelerating the development of a backup US manufacturing facility, with tech transfer underway and a supplemental BLA for this site anticipated within 2026.
- The company's cash runway is extended into 2027, supported by a Q3 cash balance of $369.6 million and recent financing, conservatively assuming no ipilimumab revenue.
Nov 18, 2025, 3:30 PM
Scholar Rock Provides Q3 2025 Update on Apitegromab Regulatory Path and Financials
SRRK
Product Launch
Guidance Update
Debt Issuance
- Scholar Rock received a Complete Response Letter (CRL) for apitegromab's Biologics License Application (BLA) on September 22, 2025, due to issues with the third-party fill-finish facility. Following a constructive Type A meeting with the FDA, the company anticipates resubmitting the BLA and a U.S. launch following approval in 2026.
- To ensure supply chain redundancy, Scholar Rock has secured commercial capacity at a second U.S.-based fill-finish facility commencing in Q1 2026, with tech transfer currently underway.
- The company ended Q3 2025 with $369.6 million in cash and cash equivalents, having strengthened its balance sheet by $141.7 million during the quarter through ATM sales and a debt facility drawdown. This cash is expected to fund operations into 2027.
- Scholar Rock is advancing its pipeline, having initiated dosing in the Phase 2 OPAL trial for apitegromab in infants and toddlers, and is on track to initiate clinical development for apitegromab in a second neuromuscular disorder and a Phase 1 study for SRK-439 before year-end 2025.
Nov 14, 2025, 1:00 PM
Scholar Rock Provides Update on Apitegromab Regulatory Status and Q3 2025 Financials
SRRK
Guidance Update
Debt Issuance
New Projects/Investments
- Scholar Rock received a Complete Response Letter (CRL) for apitegromab in SMA on September 22, 2025, with the sole approvability issue being the status of its third-party fill-finish facility.
- Following a constructive Type A meeting with the FDA, the company anticipates BLA resubmission and U.S. launch for apitegromab in 2026, as Novo Nordisk expects the facility to be ready for reinspection by the end of 2025.
- To mitigate risks and support long-term growth, Scholar Rock is accelerating timelines for a second fill-finish facility, with commercial capacity expected to commence in Q1 2026.
- For Q3 2025, Scholar Rock reported $103 million in operating expenses and ended the quarter with $369.6 million in cash and cash equivalents.
- The company strengthened its balance sheet by adding $141.7 million from an ATM offering and a debt facility drawdown, extending its cash runway into 2027.
Nov 14, 2025, 1:00 PM
Quarterly earnings call transcripts for Scholar Rock Holding.
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