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olivLaw · US equity research

Scholar Rock Holding Corp SRRK

Biological Products, (No Diagnostic Substances) · SIC 2836 · Vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)

45.50USD−1.28% · 1 dayClose 05 Nov 2026

Scholar Rock is a biopharmaceutical company developing apitegromab, an antibody that inhibits myostatin, for spinal muscular atrophy (SMA) and other rare neuromuscular diseases. The company is approaching an FDA decision with a September 30, 2026 action date that could move it from development to commercial stage, after a net loss of $215.4 million in the first half of 2026.

At the close of 05 Nov 2026, Scholar Rock Holding Corp (SRRK) stock was 45.50 USD (−1.28% on the day), with market capitalisation 5.5 bn USD, beta 1.30, 52-week range 28.80–60.04 USD. Latest reported quarter (Q2 2026): revenue of 0 USD, net income of -109.9 m USD, diluted EPS -0.84 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
5.5 bn USD
shares as of 03 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -3.33 · TTM to 30 Jun 2026
E/P (TTM)
-7.31%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
1.30
Volatility (1y) 54%
52-week range
28.8060.04

Price history

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Technical reading

RSI (14)
55.1
strong (55–70)
Bollinger (20, 2)
38.86 – 45.83
in the upper half of the band · %B 0.95 · band width 16.5%
SMA 50 / 200
47.38 / 48.19
downtrend (price < SMA50 < SMA200)
MACD (12, 26, 9)
-0.40 / -1.20
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month+7.2%−1.1%+8.3 pp—
3 months−13.6%−0.5%−13.1 pp—
6 months−2.0%+4.4%−6.4 pp—
Year to date+3.3%+12.3%−9.0 pp—
1 year+62.6%+13.5%+49.0 pp+2.1%
3 years+273.9%+76.4%+197.5 pp+0.6%
5 years+60.2%+63.7%−3.5 pp—
Max drawdown (1y)
−34.0%
26 Aug 2026 → 14 Oct 2026
Max drawdown (5y)
−86.8%
12 Nov 2021 → 01 Jun 2022
Compound annual growth (5y)
+9.9%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
0 USD
unavailable YoY
Net income
-109.9 m USD
unavailable YoY
Diluted EPS
-0.84
unavailable YoY
net / operating
unavailable / unavailable

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Revenue————0 ≈000 ≈
Research & development48.7 m50.4 m48.7 m62.4 m50.5 m46.9 m51.8 m58.2 m
Operating income-64.8 m-69.4 m-77.1 m-112.1 m-103.6 m-91.9 m-102.0 m-108.9 m
Depreciation & amortisation446.0 k ≈395.0 k393.0 k417.0 k ≈423.0 k ≈425.0 k335.0 k297.0 k ≈
Interest expense1.7 m1.6 m1.8 m1.2 m1.3 m2.5 m2.3 m4.5 m
Net income-64.5 m-66.5 m-74.7 m-110.0 m-102.2 m-91.0 m-105.5 m-109.9 m
Diluted EPS-0.66-0.61 ≈-0.67-0.98-0.90-0.76 ≈-0.83-0.84
Operating cash flow-52.5 m ≈-49.5 m-78.7 m-76.9 m ≈-68.9 m ≈-75.5 m-82.1 m-70.3 m ≈
Capex31.0 k ≈22.0 k271.0 k215.0 k ≈84.0 k ≈32.0 k68.0 k1.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year20182019202020212022202320242025
Revenue020.5 m15.4 m18.8 m33.2 munavailableunavailable0
Revenue YoYunavailableunavailable−24.8%+22.2%+76.4%unavailableunavailableunavailable
Net income-49.3 m-51.0 m-86.5 m-131.8 m-134.5 m-165.8 m-246.3 m-377.9 m
Net income YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Diluted EPSunavailableunavailable-2.81-3.59-2.26-1.99-2.47-3.29
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
net %unavailable-248.9%-561.5%-700.5%-405.2%unavailableunavailableunavailable
Free cash flow23.1 m-66.2 m-64.4 m-132.0 m-133.8 m-145.3 m-201.0 m-300.6 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
323.5 m USD
Financial debt
99.7 m USD
Net debt
-223.8 m USD
Equity
245.5 m USD
Total assets
404.3 m USD
Debt / equity
0.41x
Current ratio
6.95x
ROE
-123.1%
ROA
-86.0%
FCF margin
unavailable

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
—
2024
—
2025
0

SEC (XBRL)· 03 Mar 2026verified

Research & development
2023
121.9 m
2024
184.6 m
2025
208.4 m

SEC (XBRL)· 03 Mar 2026verified

Operating income
2023
-171.3 m
2024
-252.1 m
2025
-384.6 m

SEC (XBRL)· 03 Mar 2026verified

Depreciation & amortisation
2023
2.8 m
2024
1.9 m
2025
1.7 m

SEC (XBRL)· 03 Mar 2026verified

EBITDA
2023
-168.5 m ≈
2024
-250.1 m ≈
2025
-383.0 m ≈

SEC (XBRL)· 03 Mar 2026derived

Interest expense
2023
6.5 m
2024
6.8 m
2025
6.9 m

SEC (XBRL)· 03 Mar 2026verified

Net income
2023
-165.8 m
2024
-246.3 m
2025
-377.9 m

SEC (XBRL)· 03 Mar 2026verified

Diluted EPS
2023
-1.99
2024
-2.47
2025
-3.29

SEC (XBRL)· 03 Mar 2026verified

Weighted average diluted shares
2023
83.3 m
2024
99.8 m
2025
114.7 m

SEC (XBRL)· 03 Mar 2026verified

Balance sheet · USD

Cash
2023
101.9 m
2024
177.9 m
2025
323.5 m

SEC (XBRL)· 03 Mar 2026verified

Current assets
2023
288.2 m
2024
451.2 m
2025
385.1 m

SEC (XBRL)· 03 Mar 2026verified

Property, plant & equipment, net
2023
4.6 m
2024
2.8 m
2025
1.7 m

SEC (XBRL)· 03 Mar 2026verified

Total assets
2023
311.0 m
2024
474.9 m
2025
404.3 m

SEC (XBRL)· 03 Mar 2026verified

Accounts payable
2023
3.5 m
2024
10.1 m
2025
10.3 m

SEC (XBRL)· 03 Mar 2026verified

Short-term debt
2023
1.3 m
2024
—
2025
—

SEC (XBRL)· 19 Mar 2024verified

Long-term debt
2023
48.7 m
2024
50.1 m
2025
99.7 m

SEC (XBRL)· 03 Mar 2026verified

Current liabilities
2023
32.7 m
2024
46.9 m
2025
55.4 m

SEC (XBRL)· 03 Mar 2026verified

Total liabilities
2023
85.8 m
2024
106.3 m
2025
158.8 m

SEC (XBRL)· 03 Mar 2026verified

Equity
2023
225.2 m †
2024
368.6 m †
2025
245.5 m †

SEC (XBRL)· 03 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-145.2 m
2024
-200.9 m
2025
-300.0 m

SEC (XBRL)· 03 Mar 2026verified

Capex
2023
71.0 k
2024
98.0 k
2025
602.0 k

SEC (XBRL)· 03 Mar 2026verified

Free cash flow
2023
-145.3 m ≈
2024
-201.0 m ≈
2025
-300.6 m ≈

SEC (XBRL)· 03 Mar 2026derived

Investing cash flow
2023
41.1 m
2024
-76.1 m
2025
218.7 m

SEC (XBRL)· 03 Mar 2026verified

Financing cash flow
2023
102.6 m
2024
353.0 m
2025
228.4 m

SEC (XBRL)· 03 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
unavailable
input data missing
Revenue CAGR 3Y
unavailable
the base of the ratio is not positive
Revenue CAGR 5Y
unavailable
the base of the ratio is not positive
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
the base of the ratio is not positive
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
the base of the ratio is not positive
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
insufficient data
EBIT margin
unavailable
insufficient data
Net margin
unavailable
insufficient data
FCF margin
unavailable
insufficient data

Returns

ROE
-167.8%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-94.6%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
-477.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROCE
-90.0%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
-240.9 m USD
computed by olivLawbalance sheet at 30 Jun 2026
Net debt / EBITDA
unavailable
insufficient data
Debt / equity
0.8x
computed by olivLawbalance sheet at 30 Jun 2026
Interest coverage
-38.0x
computed by olivLawTTM to 30 Jun 2026

Liquidity

Current ratio
7.0x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
unavailable
input data missing
Cash ratio
6.1x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-296.8 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
185.0 k USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-297.0 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
insufficient data

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
5.5 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
5.3 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-7.3%
computed by olivLawTTM to 30 Jun 2026
P/B
21.8x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
unavailable
insufficient data
EV/EBITDA
unavailable
insufficient data
EV/EBIT
unavailable
insufficient data
EV/Sales
unavailable
insufficient data
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-5.4%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 4 of at least 6
  • score weight coverage: 29.2% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

45.50 USD

05 Nov 2026Source: olivLaw, closing series

Market cap: 5.5 bn USD

Key indicators

Market capitalisation
5.5 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
21.8x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
insufficient data
ROE
-167.8%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
unavailable
insufficient data
Revenue growth (YoY)
unavailable
input data missing
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

24/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 03 Aug 2026
Source: SEC (XBRL)published 06 Aug 2026
verified 943derived 82

Score by group

29% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · input data missing
  • Peers: EV/EBITDAunavailable · the base of the ratio is not positive
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Biological Products, (No Diagnostic Substances) (SIC 2836)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 29.2% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Quality-477.3%0 (vs peers)36%
Net margin · Qualityunavailableunavailable—
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-38.0x0 (on a fixed band)21%
Current ratio · Balance sheet7.0x100 (on a fixed band)14%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-5.4%0 (on a fixed band)29%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet40/100 · 2/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality· partial0/100 · 1/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

SCHOLAR ROCK HOLDING CORPORATION (SRRK). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 0 USD in 2025; ROE -167.8%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 29.2% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 7.0x

What contradicts it

  • ROIC: -477.3%
  • Interest coverage: -38.0x
  • FCF yield: -5.4%

Not assessed (insufficient data or a ratio without meaning): Net margin, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Biological Products, (No Diagnostic Substances) (SIC 2836) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 21.7x
EV/EBITDA
—
vertical median —
P/S
—
vertical median 13.0x
P/B
21.8x
vertical median 3.9x
above median (+461.6%)
ROE
-167.8%
vertical median -37.3%
below median
Net margin
—
vertical median -238.7%
EBIT margin
—
vertical median -263.8%
Revenue YoY
—
vertical median 4.4%
Net debt/EBITDA
—
vertical median —
Dividend yield
—
vertical median 1.9%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
AMGNAmgen Inc.258.8 bn27.778.4%24.1%+10.0%+39% / +77%
GILDGilead Sciences, Inc.216.4 bn—-22.3%-12.5%+2.4%+39% / +128%
MRNAModerna, Inc.103.2 bn—-39.0%-141.4%−39.9%+895% / +233%
RVMDRevolution Medicines, Inc.43.2 bn—-93.6%-946.8%unavailable+157% / +756%
BIIBBiogen Inc.37.6 bn108.81.9%3.4%+2.2%+40% / +9%
EXELExelixis, Inc.17.8 bn21.744.3%35.5%+7.0%+65% / +234%
KYMRKymera Therapeutics, Inc.10.9 bn—-27.3%-341.8%−16.7%+89% / +517%
KRYSKrystal Biotech, Inc.8.9 bn40.817.5%47.9%+33.9%+38% / +188%
CGONCG Oncology, Inc.5.7 bn—-26.4%-3,602.7%+254.7%+45% / unavailable
SRRKScholar Rock Holding Corporation5.5 bn—-167.8%—unavailable+63% / +274%
ADPTAdaptive Biotechnologies Corporation4.3 bn—-37.1%-23.7%+54.8%+36% / +513%
BEAMBeam Therapeutics Inc.2.7 bn—-11.3%-73.9%+120.0%+2% / −8%
RXRXRecursion Pharmaceuticals, Inc.2.2 bn—-48.7%-697.1%+26.9%−24% / −49%
BCRXBiocryst Pharmaceuticals, Inc.2.0 bn——-37.4%+94.1%+6% / +30%
MAZEMaze Therapeutics, Inc.1.8 bn—-37.3%-5,343.6%unavailable−14% / unavailable
MGTXMeiraGTx Holdings plc817.3 m12.172.2%19.9%+144.6%+3% / +63%
SLDBSolid Biosciences Inc.689.8 m—-76.9%—−40.6%+14% / +119%
DNAGinkgo Bioworks Holdings, Inc.634.6 m—-56.3%-260.0%−25.1%+7% / −81%
CADLCandel Therapeutics, Inc.615.2 m—-81.8%—0.0%+69% / +794%
AUTLAutolus Therapeutics plc335.4 m—-133.0%-238.7%+644.9%−11% / −71%
OCGNOcugen, Inc.277.0 m——-1,367.6%+8.8%−34% / +111%
SABSSab Biotherapeutics, Inc.267.5 m—-11.3%—−100.0%−26% / −70%
PLXProtalix BioTherapeutics, Inc.202.2 m10.931.2%23.5%−1.2%+41% / +66%
PALIPalisade Bio, Inc.202.2 m—-51.4%-6,388.2%unavailable−45% / −88%
ARTVArtiva Biotherapeutics, Inc.201.9 m—-36.6%—−100.0%+10% / unavailable

1- and 3-year price returns: for SRRK from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Scenarios are not available. input data missing

AI analysis

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

In brief

Scholar Rock is a biopharmaceutical company developing apitegromab, an antibody that inhibits myostatin, for spinal muscular atrophy (SMA) and other rare neuromuscular diseases. The company is approaching an FDA decision with a September 30, 2026 action date that could move it from development to commercial stage, after a net loss of $215.4 million in the first half of 2026 23.

SWOT

Strengths

  • The proprietary platform targeting latent growth factor forms is patented and offers high selectivity against structurally related proteins.
  • Apitegromab has a positive pivotal Phase 3 result and a defined FDA action date, bringing the company close to its first commercial product.
  • The balance sheet is supported by roughly $492 million in cash and marketable securities at June 30, 2026, with additional funds from the ATM program.

Weaknesses

  • The company has no history of product sales and has not generated product revenue to date.
  • Net losses have been recorded since inception, and the accumulated deficit now exceeds one billion dollars.
  • Reliance on third parties for manufacturing and fill-finish has caused a significant approval delay.

Opportunities

  • FDA approval could allow an immediate U.S. launch and could support expansion to other countries.
  • Studies in FSHD and other neuromuscular diseases could extend the market beyond SMA.
  • Partnerships for early-stage programs and for combinations with metabolic therapies could bring additional funding.

Threats

  • The FDA decision could be delayed or restricted if manufacturing issues are not resolved.
  • The European timeline could slip if the inspection classification remains unclear or if EMA requests additional information.
  • European pricing and reimbursement could limit potential revenue even after an approval.

Risks

  • FDA approval delayhigh

    If the problems at a third-party facility are not resolved, approval of apitegromab could be postponed beyond the September 2026 action date.

  • Inspection classificationhigh

    The OAI classification of a facility could affect the EMA process if the authority requests additional assurance.

  • Launch without commercial experiencemedium

    The company has never sold a product and could face difficulty building sales teams and market access capabilities.

  • Need for additional fundingmedium

    Continued losses could require additional capital, which could dilute current shareholders.

  • Share price volatilitylow

    The share price is volatile, and investors could lose part or all of their investment, as the filing warns.

Investment thesis

What would need to be true (bull case)

  • If the FDA approves apitegromab by the September 2026 date, the company could become the first to launch a myostatin inhibitor for SMA.
  • The cash position and ATM funding could cover launch costs if approval arrives on time.
  • Expansion into FSHD and other rare diseases could increase the platform's value beyond a single product.

What would break the thesis

  • If the second fill-finish facility or the Catalent facility does not receive a favorable classification, the timeline could slip well beyond September 2026.
  • High net losses could continue even after approval if sales grow slowly.
  • European pricing and reimbursement negotiations could significantly reduce potential revenue.

What to watch

  • FDA decision on apitegromab and the Catalent inspection classificationSeptember 2026
  • EMA timeline and possible addition of the second fill-finish facility to the MAA2026
  • Use of the ATM program and evolution of cash and marketable securitiesQ3 2026

Products, market & competition

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

The business

Scholar Rock is a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy and other rare, severe and debilitating neuromuscular diseases 1. Its foundation is a proprietary platform that targets the latent, precursor forms of growth factors in the TGFβ superfamily, enabling selective monoclonal antibodies 1. The company has not generated product sales revenue to date and reported a net loss of $377.9 million for fiscal 2025 1.

The lead product, apitegromab, is an investigational fully human monoclonal antibody that inhibits myostatin activation by selectively binding its pro and latent forms in skeletal muscle 1. The Phase 3 SAPPHIRE study met its primary endpoint, and the BLA was submitted to the FDA in January 2025 with priority review, while the EMA validated the MAA in March 2025 1. After a Complete Response Letter in September 2025, the BLA was resubmitted in March 2026 and accepted with a September 30, 2026 PDUFA date 2.

Segments

Apitegromab in SMA

Apitegromab is the main product for SMA, a disease in which an estimated 35000 patients worldwide have received an approved SMN-targeted treatment 1. A U.S. launch is ready immediately upon approval, with Germany as the first European market 13.

FSHD and other indications

The Phase 2 FORGE study in FSHD plans to enroll approximately 60 patients, with a primary endpoint at 12 months 3. The company is also seeking partners to combine myostatin inhibition with GLP-1 weight loss approaches 1.

Market context

The target market is rare neuromuscular disease, where there is significant unmet need for therapies that address progressive muscle weakness 1. The FSHD market, with approximately 30000 individuals in the U.S. and Europe, is one of the indications under review 1. European market access depends on pricing and reimbursement negotiations that can be lengthy and uncertain 1.

Commercial activity depends on the outcome of the FDA review and on a possible EMA approval, which in turn depends on the inspection classification of a third-party fill-finish facility 23. The market outlook remains closely tied to the FDA decision due by September 2026.

Trends

  • Muscle-targeted therapy beyond SMNtailwind

    Research indicates that targeting myostatin can increase muscle mass, which could open opportunities across several neuromuscular diseases, not only SMA 1.

  • Regulatory pressure on manufacturingheadwind

    Observations at a third-party fill-finish facility led to a CRL and an OAI classification, which delayed the commercial timeline 12.

  • European pricing and reimbursementheadwind

    Price and reimbursement negotiations in the EU are lengthy and vary country by country, which could limit patient access 1.

  • Capital markets fundingmixed

    The company has raised funds through its at-the-market program, which supports operations while adding dilution pressure for shareholders 3.

Competitive position

The company states that apitegromab would be the first myostatin inhibitor with a statistically significant Phase 3 outcome, which could offer an advantage over other approaches 23. Existing SMN-targeted treatments remain the main alternative for patients, and the exact competitive landscape is not detailed in the analysed sources 1.

Traditional approaches that inhibit mature myostatin or the ActRIIb receptor face selectivity limitations, which could lead other companies to pursue similar targets 1. The company argues its latent-targeting platform could reduce effects on related growth factors 1.

  • SMN-targeted therapies for SMA

    Approved SMA treatments with which apitegromab could be used in combination or as an alternative, as described in the company filing

  • Traditional myostatin inhibitors

    Antibodies targeting mature myostatin or the ActRIIb receptor, approaches the company describes as having selectivity limitations

  • Other anti-myostatin programs in development

    Clinical or preclinical programs in the field, not identified in the analysed sources

  • FSHD therapies

    Treatment options in development for FSHD, an indication targeted by the FORGE study

News & filings

In the press

The latest news item in our archive is from 14 Sept 2026; the newest SEC filing is from 15 Sept 2026. The press archive comes from the RSS feeds we follow and does not necessarily cover the latest event — the filings alongside do.

SEC filings

Sources

  1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Scholar Rock Holding Corp · 03 Mar 2026
  2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Scholar Rock Holding Corp · 06 Aug 2026
  3. [3] Form 8-K, results release (exhibit 99.1) · SEC / Scholar Rock Holding Corp · 06 Aug 2026

Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.