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 Provides 2026 Outlook and Apitegromab Launch Update
SRRK
Product Launch
New Projects/Investments
Guidance Update
- Scholar Rock anticipates U.S. and European approval and launches for Apitegromab in 2026 for children and adults with Spinal Muscular Atrophy (SMA), with the initial European launch in Germany. The company is preparing for a $2 billion-plus global opportunity for Apitegromab in SMA alone.
- The BLA resubmission for Apitegromab is progressing, with an FDA meeting in early Q1 2026 to discuss remediation at the Catalent fill-finish facility. Commercial supply is ready for launch.
- The company is expanding its pipeline, with Apitegromab Phase II dosing for FSHD patients commencing later in 2026 and SRK-439 Phase I top-line data expected in the second half of 2026.
- Scholar Rock reported approximately $365 million in cash and equivalents at the close of 2025, providing a cash runway into 2027.
3 days ago
Scholar Rock Provides 2026 Outlook and Apitegromab Launch Update
SRRK
Product Launch
New Projects/Investments
Guidance Update
- Scholar Rock anticipates U.S. and European approvals and launches for its lead product, apitegromab, in 2026, with Germany as the initial European market. The company projects a $2 billion+ global market opportunity for apitegromab in SMA alone.
- The Complete Response Letter (CRL) for apitegromab's Biologics License Application (BLA) was solely due to a general site inspection at the Catalent, Indiana fill-finish facility. An FDA meeting with Novo Nordisk (the facility owner) is scheduled for early Q1 2026 to discuss remediation, and Scholar Rock remains confident in a 2026 U.S. launch.
- The company announced FSHD as the next indication for apitegromab, with patient dosing in a Phase II study (FORGE) expected to commence later in 2026. Additionally, a Phase I study for SRK-439 began dosing healthy volunteers in Q4 2025, with top-line data anticipated in the second half of 2026.
- Scholar Rock reported approximately $365 million in cash and equivalents at the close of 2025, providing a cash runway into 2027. This estimate is conservative and does not include potential revenues from 2026 launches or the monetization of a priority review voucher.
3 days ago
Scholar Rock Updates on Apitegromab Approval, Pipeline, and Financials
SRRK
Product Launch
New Projects/Investments
Guidance Update
- Scholar Rock anticipates U.S. and European approval for Apitegromab for children and adults with SMA in 2026, with launches expected to follow, starting with Germany in the second half of 2026. The company estimates a $2 billion-plus opportunity for Apitegromab in SMA alone and plans to build a 50-country operating platform.
- The company reported approximately $365 million in cash and equivalents at the close of 2025, providing a cash runway into 2027. This estimate is conservative as it does not include potential revenues from 2026 launches or monetizing the rare disease priority review voucher.
- Regulatory progress for Apitegromab's BLA resubmission is ongoing, with the FDA scheduled to meet with Novo Nordisk in early Q1 to discuss remediation plans for the Catalent, Indiana fill-finish facility. Scholar Rock remains confident in a 2026 U.S. launch.
- Scholar Rock is expanding Apitegromab's pipeline, with dosing for a Phase II study in FSHD to begin later in 2026 and top-line data for the SRK-439 Phase I study expected in the second half of 2026.
3 days ago
Scholar Rock Highlights 2026 Strategic Priorities and Financial Position
SRRK
Product Launch
New Projects/Investments
Guidance Update
- Scholar Rock anticipates apitegromab Biologics License Application (BLA) resubmission and U.S. launch in 2026 for spinal muscular atrophy (SMA) following FDA approval, with an EMA decision expected in mid-2026.
- The company reported approximately $365 million in cash as of December 31, 2025, providing a cash runway expected to support operations into 2027.
- A Phase 2 study for apitegromab in facioscapulohumeral muscular dystrophy (FSHD) is on track to initiate in mid-2026, and topline data for SRK-439's Phase 1 trial are expected in H2 2026.
- To strengthen supply continuity, Scholar Rock has reserved commercial capacity at a second U.S. fill-finish facility beginning Q1 2026.
3 days ago
Scholar Rock Highlights 2026 Strategic Priorities and Financial Position
SRRK
Product Launch
New Projects/Investments
Guidance Update
- Scholar Rock anticipates apitegromab BLA resubmission and U.S. launch in 2026 for spinal muscular atrophy (SMA), with an FDA meeting scheduled in early 2026 to discuss manufacturing remediation efforts.
- The EMA regulatory review for apitegromab is ongoing, with a decision expected in mid-2026, and a second U.S. fill-finish facility has been reserved for commercial capacity starting Q1 2026.
- The company plans to initiate a Phase 2 study for apitegromab in facioscapulohumeral muscular dystrophy (FSHD) in mid-2026 and expects topline data from the SRK-439 Phase 1 trial in H2 2026.
- Scholar Rock reported approximately $365 million in cash as of December 31, 2025, providing a cash runway into 2027.
3 days ago
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
Quarterly earnings call transcripts for Scholar Rock Holding.
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