SRRKNasdaqBiological Products, (No Diagnostic Substances)US GAAP · USD

Scholar Rock Holding Corp

Scholar Rock Holding Corp is a U.S.-based biotechnology company focused on discovering and developing medicines that modulate growth factor signaling for severe diseases. Its lead programs center on apitegromab and other anti-myostatin candidates for neuromuscular disorders, with development, manufacturing, and future commercialization activities organized through third-party partners and internal research capabilities.

Kysy yhtiöstä
Liikevaihto0,0milj. USD
Liikevoitto (EBIT)−385milj. USD
−52,6 %v/v
Nettotulos−378milj. USD
−53,5 %v/v
Vapaa kassavirta−301milj. USD
−49,5 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−400−300−200−1000100milj. USD2020: 15 milj. USD2020: EBIT −87 milj. USD20202021: 19 milj. USD2021: EBIT −130 milj. USD20212022: 33 milj. USD2022: EBIT −134 milj. USD20222023: 33 milj. USD2023: EBIT −171 milj. USD20232024: EBIT −252 milj. USD20242025: 0,00 milj. USD2025: EBIT −385 milj. USD20250,00−385
LiikevaihtoLiikevoitto (EBIT)
Kysy Clarifolta: Scholar Rock Holding Corp

Liiketoiminta

Osuus liikevaihdosta
Lead therapeutic candidate0 %

Apitegromab and related clinical-stage development for SMA and adjacent neuromuscular uses.

Pipeline biologics0 %

Anti-myostatin and other antibody-based programs under preclinical and clinical development.

Discovery platform0 %

Proprietary antibody discovery and optimization capabilities used to generate new candidates.

Development and regulatory activities0 %

Clinical trial execution, regulatory filings, and supporting development work for product candidates.

Asiakkaat

Scholar Rock’s direct end customers, if its products are approved, are patients with rare neuromuscular diseases and the physicians who treat them. In practice, commercialization depends on neurologists, specialty clinics, hospitals, and third-party payors that determine prescribing, access, and reimbursement. The company also relies on contract manufacturers, research vendors, and potential commercial partners to support development and launch activities.

SMA patients and treating physicians

They would use apitegromab if approved to treat spinal muscular atrophy and related neuromuscular conditions.

Rare disease payors and market access stakeholders

They determine coverage, reimbursement, and formulary access for high-cost specialty biologics.

Specialty neuromuscular clinics

They diagnose, monitor, and administer therapies for patients in the target disease areas.

Research and manufacturing partners

They provide discovery, clinical manufacturing, and development services under outsourced arrangements.

Strategia

The company’s strategy is to advance apitegromab through regulatory approval and build the commercial infrastructure needed for launch in neuromuscular disease. It is also broadening its pipeline around anti-myostatin biology while relying on outsourced manufacturing and selective external partners to scale efficiently.

Regulatory advancement of apitegromabLyhyt aikaväli

Approval is the key value-creation step and the basis for first product revenue.

Commercial build-outLyhyt aikaväli

The company needs sales, market access, medical affairs, and distribution capabilities to launch.

Pipeline expansionKeskipitkä aikaväli

A broader portfolio reduces dependence on a single lead asset and extends the platform.

Maantiede

Scholar Rock is headquartered in the United States and develops therapies for global markets, with commercialization planning in both the U.S. and Europe. The company has specifically referenced launch preparation in Germany as part of its European build-out, while clinical and regulatory work spans U.S. and European agencies. Its outsourced manufacturing and development model also creates exposure to third-party suppliers and service providers across multiple jurisdictions.

Riskit

Scholar Rock faces the classic biotech risk stack: clinical failure, regulatory delay, and uncertainty around eventual commercialization. Because it has no product sales history and depends on third parties for manufacturing and development, execution risk, reimbursement risk, and financing needs are all material.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Clinical development failure1Regulatory delay or rejection2Commercialization execution risk3Reimbursement and pricing pressure4Manufacturing and supply chain dependence5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Clinical development failureVaikutus: KriittinenTodennäköisyys: Kohtalainen

    Lead assets must prove efficacy and safety in pivotal and follow-on studies before approval.

    KohdistuuApitegromabSRK-439Other pipeline programs
  2. Regulatory delay or rejectionVaikutus: KorkeaTodennäköisyys: Kohtalainen

    FDA and EMA decisions determine whether the company can commercialize its lead product.

    Kohdistuu: BLA/MAA review and post-review requirements

  3. Commercialization execution riskVaikutus: KorkeaTodennäköisyys: Kohtalainen

    The company has limited sales and distribution experience and must build capabilities or partner.

    Kohdistuu: U.S. and European launch readiness

  4. Reimbursement and pricing pressureVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Specialty biologics depend on third-party payor coverage and favorable access terms.

    Kohdistuu: Rare disease market access

  5. Manufacturing and supply chain dependenceVaikutus: KeskitasoTodennäköisyys: Kohtalainen

    All clinical manufacturing is outsourced, increasing reliance on third-party capacity and quality.

    Kohdistuu: Clinical supply and future commercial supply

Kysy Clarifolta: Scholar Rock Holding Corp

Kirjanpito

Harkinnanvaraiset erät
Research and development expense recognition

Clinical trials, manufacturing, and discovery costs are expensed as incurred and drive reported losses.

Vaikutus: Affects operating loss and comparability across periods

Stock-based compensation

Equity awards and modifications can create large non-cash G&A charges.

Vaikutus: Can materially affect reported operating expense

Capitalization and liquidity assumptions

The company must estimate how long existing cash will fund operations and future trials.

Vaikutus: Important for going-concern and financing analysis

Collaboration and license accounting

Any future partner payments, milestones, or licenses may require judgment on timing and classification.

Vaikutus: Could affect revenue or other income recognition

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Päivitetty: 24.9.2026