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Scholar Rock Holding Corp (SRRK)
NASDAQ:SRRK
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Scholar Rock Holding
(NASDAQ:SRRK)
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Rating:54Neutral
Price Target:
$48.00
▲(1.20% Upside)
Action:ReiteratedDate:03/05/26
The score is held back primarily by weak financial performance (zero revenue, expanding losses, and substantial cash burn), which increases financing risk. Offsetting this, the latest earnings call highlighted meaningful regulatory and commercial progress toward a 2026 launch and improved funding flexibility, while technicals are constructive with the stock trading above major moving averages. Valuation remains challenging given negative earnings.
Positive Factors
Regulatory momentum toward BLA resubmission
Active FDA engagement, including a field visit and planned reinspection, materially improves the company's ability to close a prior approvability gap. Sustained regulatory dialogue and a clear resubmission path reduce long-term approval uncertainty and support commercial planning and partner/payer discussions.
Strengthened liquidity and staged financing optionality
Significant cash on hand plus a structured, milestone-linked $550M facility meaningfully extend runway and lower immediate dilution pressure. Staged access tied to approval provides optionality to fund pre-launch commercialization and pipeline programs while preserving flexibility for alternative monetization strategies.
Commercial preparedness and distribution network
Early investment in field teams, specialty pharmacy relationships and a large home‑infusion network creates durable go‑to‑market capabilities. This infrastructure supports faster uptake post-approval, aids payer negotiations, and reduces time-to-treatment compared with competitors starting launch prep later.
Negative Factors
Zero revenue and high cash burn
Sustained absence of product revenue and rapidly expanding net losses translate into persistent negative operating and free cash flow. This elevates financing and dilution risk, forces ongoing capital markets or debt reliance, and constrains discretionary R&D and commercial investments until revenue materializes.
Catalent manufacturing compliance is a gating issue
A third‑party facility's compliance status is a binary, high-impact risk that can delay or block approval regardless of clinical data. Dependence on Catalent's remediation and reinspection timeline creates material regulatory timing uncertainty that directly threatens launch schedules and commercial revenue timing.
Supply concentration and third‑party reliance
Until a second fill‑finish site is qualified and approved, the company faces single‑source supply risk that can disrupt launch and create inventory constraints. This reliance increases operational fragility, may raise manufacturing costs, and complicates payer/provider confidence during initial commercialization.
Scholar Rock Holding (SRRK) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$4.52B
Dividend YieldN/A
Average Volume (3M)904.23K
Price to Earnings (P/E)―
Beta (1Y)1.75
Revenue GrowthN/A
EPS Growth-31.71%
CountryUS
Employees128
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.88
Shares Outstanding102,007,454
10 Day Avg. Volume909,520
30 Day Avg. Volume904,229
Financial Highlights & Ratios
PEG Ratio-0.40
Price to Book (P/B)20.58
Price to Sales (P/S)0.00
P/FCF Ratio-16.81
Enterprise Value/Market Cap1.02
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-2.79K
Enterprise Value/Ebitda-12.52
Forecast
1Y Price Target
$56.60Price Target Upside19.33% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering12
EPS Forecast (FY)-3.05
Revenue Forecast (FY)$32.23M
Scholar Rock Holding Business Overview & Revenue Model
Company DescriptionScholar Rock Holding Corporation, a biopharmaceutical company, focuses on the discovery and development of medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. The company develops Apitegromab, an inhibitor of the activation of latent myostatin that has completed the Phase 3 clinical trials for the treatment of spinal muscular atrophy; and SRK-181, which is in Phase 1 clinical trials for the treatment of cancers that are resistant to checkpoint inhibitor therapies, such as anti-PD-1 or anti-PD-L1 antibody therapies. It is also developing a pipeline of novel product candidates with potential to transform the lives of patients suffering from a range of serious diseases, including neuromuscular disorders, cancer, and fibrosis. The company has a collaboration agreement with Gilead Sciences, Inc. to discover and develop specific inhibitors of transforming growth factor beta activation for the treatment of fibrotic diseases. Scholar Rock Holding Corporation was founded in 2012 and is headquartered in Cambridge, Massachusetts.
How the Company Makes MoneyScholar Rock makes money primarily through the development and commercialization of its proprietary drug candidates. The company's revenue model includes partnerships and collaborations with larger pharmaceutical companies, which provide upfront payments, milestone payments, and royalties on future sales of successfully developed drugs. Additionally, Scholar Rock may generate income through licensing agreements, where it grants other companies the rights to develop and market its therapeutic candidates. The company's financial performance is heavily influenced by the progress of its clinical trials, regulatory approvals, and the successful commercialization of its products.
Scholar Rock Holding Earnings Call Summary
Earnings Call Date:Mar 03, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 12, 2026
Earnings Call Sentiment Positive
The call conveyed strong forward momentum: focused regulatory engagement with FDA (including a field visit), readiness to resubmit the BLA following an expected reinspection, an advancing clinical pipeline (multiple studies including FSHD and SRK‑439), active commercial build (field team, specialty pharmacy and home infusion networks), and materially strengthened financing optionality (warrant proceeds plus a $550M debt facility). The key negative is continued regulatory and manufacturing risk tied to Catalent’s remediation status, plus high pre‑launch operating spend and potential payer access timing issues. On balance, the highlights—substantive regulatory engagement, concrete mitigation steps (second fill‑finish facility), robust pipeline progress, commercial preparedness, and improved liquidity—outweigh the remaining execution risks.Q4-2025 Updates
Positive Updates
Regulatory momentum toward U.S. resubmission and 2026 launch
Company reaffirmed guidance to resubmit the BLA and target a U.S. launch upon approval in 2026. Since the November Type A meeting, FDA engagement has been active (including an FDA field team visit to the Catalent, IN site) and the FDA indicated intent to reinspect the Catalent facility after routine manufacturing resumed in late February. Management is prepared to resubmit the BLA quickly following a successful reinspection.
European MAA review progressing
The Marketing Authorization Application (MAA) with the EMA is under review and management expects a decision in mid-2026, enabling potential launch sequencing in Europe beginning with Germany in H2 2026.
Pipeline progress — multiple programs advancing
Phase 2 OVAL (ipilimumab/epitogromab) continues enrolling infants/toddlers (<2 years) including SMN-treated patients. FSHD IND cleared and FORGE Phase 2 (randomized, placebo-controlled, ~60 patients) is on track to start mid-2026. SRK‑439 (high‑potency myostatin inhibitor) is dosing in Phase 1 with topline data expected in H2 2026. Subcutaneous formulation Phase 1 showed 800 mg subQ produced overlapping PD with 800 mg IV; further clinical/regulatory strategy planned.
Commercial preparedness and community engagement
U.S. commercial team deployed: engaging ~140 SMA treatment centers and ~2,600 prescribing physicians; expanded specialty pharmacy network for continuity of care; home infusion network with >10,000 affiliated nurses; disease awareness campaign 'Life Takes Muscle' launched; active payer engagement (national/regional, Medicare/Medicaid).
Strengthened balance sheet and financing flexibility
Ended 2025 with $368,000,000 in cash and cash equivalents. Q4 included $60,400,000 from warrant exercises (≈16% of year-end cash). Secured a new debt facility with Blue Oak Capital for up to $550,000,000 (≈149% of year-end cash): $100,000,000 available at close (used to repay prior facility), additional $100,000,000 expected this quarter, option to draw $150,000,000 following FDA approval, and incremental option up to $200,000,000 by mutual consent.
Operating spend transparency and prioritization
Q4 2025 operating expenses were $91,900,000 (including $19,400,000 non‑cash stock-based compensation). Excluding stock comp, Q4 operating expenses were $72,500,000. Full year 2025 operating expenses were $384,600,000 (including $75,600,000 stock comp); ex-stock comp FY2025 op ex = $309,000,000. Non‑cash stock compensation represented ~21.1% of Q4 op ex and ~19.7% of FY op ex.
Negative Updates
Manufacturing compliance at Catalent created sole approvability issue
FDA warning letter to Catalent (Indiana) was cited as the sole approvability issue in the prior CRL. The BLA resubmission gating item remains a successful FDA reinspection of Catalent; timing and outcome of that reinspection introduce material uncertainty and potential delays to resubmission/approval.
Supply chain concentration risk and reliance on third parties
Current reliance on the Catalent fill‑finish site created regulatory exposure; while a second U.S. fill‑finish facility is being qualified (engineering runs underway) and a supplemental BLA is planned for 2026, supply and timing risk remain until the second facility is fully validated and approved.
High operating spend and funding needs ahead of revenue
Full year 2025 operating expenses were $384.6M (ex-stock comp $309.0M) while year-end cash was $368.0M. Although a $550M debt facility increases flexibility, the company will still need to balance heavy investment in commercial launch and R&D; management noted profitability could be 2–3 years post-launch, implying continued need for financing or monetization events (e.g., priority review voucher).
Potential payer access and launch uptake headwinds
Management expects strong demand but flagged likely access/reimbursement bottlenecks at launch—Medicaid and some payers could be slow to reimburse—which could blunt initial uptake despite high physician/patient interest. The product is weight-based, implying pricing/range complexity at launch.
Historical myostatin inhibitor efficacy risk for new indications
Management acknowledged prior myostatin inhibitors increased muscle mass without clear functional gains in some contexts; FORGE Phase 2 will use muscle volume as primary endpoint with functional measures included, but there remains execution risk that increased lean mass may not translate to clinically meaningful functional improvement.
Company Guidance
Scholar Rock reaffirmed guidance to resubmit the BLA and achieve a U.S. launch following approval in 2026 (contingent on a successful FDA reinspection of the Catalent, Indiana site) and expects an EMA decision in mid‑2026, with a supplemental BLA for a second fill‑finish facility planned later in 2026; pipeline milestones include ongoing enrollment in the Phase 2 OVAL study, a 60‑patient Phase 2 FORGE study in FSHD planned to start mid‑2026, and top‑line Phase 1 data for SRK‑439 expected in H2 2026. Financially, the company ended 2025 with $368.0M in cash (including $60.4M from warrant exercises), reported Q4 operating expenses of $91.9M (SBC $19.4M; ex‑SBC $72.5M) and full‑year 2025 OpEx of $384.6M (SBC $75.6M; ex‑SBC $309.0M), and secured a debt facility of up to $550M ( $100M available and used immediately to repay prior debt, an additional $100M expected to be drawn by March 31, a $150M option upon FDA approval, and an optional incremental $200M by mutual consent) and intends to monetize a priority review voucher as additional balance‑sheet support. Commercial readiness metrics highlighted: engagement across ~140 SMA treatment centers, ~2,600 prescribing physicians, an expanded specialty‑pharmacy network, and a home‑infusion network of >10,000 affiliated nurses, targeting a market where SMN‑targeted therapies represent nearly $5.0B in annual global sales and where ~95% of patients continue to experience progressive muscle weakness.Scholar Rock Holding Financial Statement Overview
Summary
Financial statements indicate a high-burn profile with deteriorating operating fundamentals: revenue has fallen to zero in 2023–2025, net losses expanded materially (to ~$377.9M in 2025), and operating/free cash flow remain deeply negative (operating cash flow roughly -$300M in 2025). Leverage is not extreme (debt-to-equity ~0.44), but equity erosion and sustained cash burn elevate financing/dilution risk until revenue ramps.Income Statement
Operating performance is very weak and deteriorating: the company has moved from modest revenue in 2020–2022 to zero reported revenue in 2023–2025, while losses expanded materially (net loss grew from about $86.5M in 2020 to about $377.9M in 2025). Profitability is consistently negative across the period, indicating the business is not close to self-funding at the income statement level. A modest positive is that 2020–2022 showed some revenue base before it disappeared, but the overall trajectory is unfavorable.12
Very Negative
Balance Sheet
Leverage is moderate, with debt-to-equity generally below 0.5 (2025 ~0.44), which suggests the company is not heavily debt-funded. However, equity has been volatile and lower versus 2024 (equity fell from about $368.6M in 2024 to about $245.5M in 2025), consistent with ongoing losses. Returns on equity are deeply negative (2025 roughly -154%), highlighting that the balance sheet is being pressured by sustained cash burn and income losses.48
Neutral
Cash Flow
Cash generation is weak: operating cash flow and free cash flow are consistently negative and worsening in absolute dollars (operating cash flow from about -$60.3M in 2020 to about -$300.0M in 2025). While free cash flow has broadly tracked net losses (free cash flow to net income near ~1.0), that mainly indicates losses are translating into real cash outflows rather than being cushioned by non-cash items. Free cash flow growth is volatile (including a sharp rebound in 2025), but the overall level of cash burn remains high, increasing financing risk over time.18
Very Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 33.19M | 18.82M |
| Gross Profit | 0.00 | -1.94M | -2.84M | -89.85M | -89.65M |
| EBITDA | -369.39M | -237.52M | -162.94M | -129.48M | -127.29M |
| Net Income | -377.94M | -246.29M | -165.79M | -134.50M | -131.80M |
Balance Sheet | |||||
| Total Assets | 404.27M | 474.92M | 311.04M | 358.17M | 304.44M |
| Cash, Cash Equivalents and Short-Term Investments | 367.56M | 437.28M | 279.94M | 315.36M | 252.99M |
| Total Debt | 108.92M | 65.13M | 61.82M | 69.40M | 84.47M |
| Total Liabilities | 158.78M | 106.29M | 85.82M | 97.93M | 132.37M |
| Stockholders Equity | 245.49M | 368.63M | 225.22M | 260.24M | 172.07M |
Cash Flow | |||||
| Free Cash Flow | -300.64M | -201.05M | -145.30M | -133.76M | -132.04M |
| Operating Cash Flow | -300.04M | -200.95M | -145.23M | -132.69M | -126.79M |
| Investing Cash Flow | 218.69M | -76.06M | 41.14M | -171.70M | 134.31M |
| Financing Cash Flow | 228.40M | 353.03M | 102.57M | 194.83M | 44.95M |
Scholar Rock Holding Technical Analysis
Positive
47.43
Price Trends
45.32
Positive
40.82
Positive
37.59
Positive
Market Momentum
0.03
Positive
55.85
Neutral
44.83
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SRRK, the sentiment is Positive. The current price of 47.43 is above the 20-day moving average (MA) of 46.43, above the 50-day MA of 45.32, and above the 200-day MA of 37.59, indicating a bullish trend. The MACD of 0.03 indicates Positive momentum. The RSI at 55.85 is Neutral, neither overbought nor oversold. The STOCH value of 44.83 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for SRRK.
Scholar Rock Holding Risk Analysis
Scholar Rock Holding disclosed 70 risk factors in its most recent earnings report. Scholar Rock Holding reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Scholar Rock Holding Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
63 Neutral | $3.64B | -10.27 | -51.76% | ― | ― | -38.30% | |
62 Neutral | $5.44B | ― | -69.35% | ― | ― | -27.70% | |
55 Neutral | $3.58B | -19.69 | -28.29% | ― | ― | ― | |
54 Neutral | $4.52B | -13.37 | -123.08% | ― | ― | -31.71% | |
52 Neutral | $3.69B | -6.36 | -47.34% | ― | ― | -126.16% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
46 Neutral | $2.11B | -3.94 | -656.54% | ― | 20.63% | 8.09% |
* Healthcare Sector Average
SRRK
Scholar Rock Holding
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31.24%
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Scholar Rock Holding Corporate Events
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Scholar Rock Advances Apitegromab Toward SMA Commercial Launch
Positive
Mar 3, 2026
On March 3, 2026, Scholar Rock reported fourth-quarter and full-year 2025 results, highlighting rapid progress toward bringing its lead SMA therapy apitegromab to market despite continued losses. The company is positioning itself as a key player in neuromuscular diseases through an SMA-focused commercial build-out, expanded manufacturing plans, and advancement of its broader myostatin-based pipeline.
Scholar Rock expects to resubmit apitegromab’s Biologics License Application in the U.S. in 2026 following a successful FDA reinspection of Novo Nordisk’s Catalent Indiana site and is preparing for a potential U.S. launch that year, while a European regulatory decision is anticipated in mid-2026 with a planned launch starting in Germany in the second half. The firm continues to advance the Phase 2 OPAL trial in very young SMA patients, develop a subcutaneous formulation of apitegromab, ready an FSHD Phase 2 trial for mid-2026, and dose volunteers in a Phase 1 study of SRK-439.
To support commercialization and pipeline development, Scholar Rock secured a new debt facility of up to $550 million from funds managed by Blue Owl Capital, replacing its prior Oxford Finance debt and providing staged access to additional capital tied in part to apitegromab’s regulatory milestones. As of December 31, 2025, the company held $367.6 million in cash, cash equivalents and marketable securities, but reported a larger net loss of $91.0 million in the fourth quarter and $377.9 million for the full year, reflecting ongoing R&D and ramping general and administrative expenses without any product revenue.
The most recent analyst rating on (SRRK) stock is a Buy with a $55.00 price target. To see the full list of analyst forecasts on Scholar Rock Holding stock, see the SRRK Stock Forecast page.
Business Operations and StrategyFinancial Disclosures
Scholar Rock Details 2026 Strategy and Regulatory Priorities
Positive
Jan 12, 2026
On January 12, 2026, Scholar Rock issued a corporate update outlining 2026 strategic priorities centered on securing U.S. and European regulatory approvals and commercial launch for apitegromab in children and adults with SMA, expanding development of apitegromab into infants under two years of age and FSHD, and advancing its broader anti-myostatin pipeline including subcutaneous apitegromab and SRK-439. The company reported an estimated $365 million in cash, cash equivalents and marketable securities as of December 31, 2025, providing runway into 2027, highlighted progress on remediation and capacity expansion at U.S. fill-finish manufacturers to underpin supply for apitegromab, and detailed 2025 milestones including major FDA and EMA regulatory steps, leadership restructuring to support its transition to a commercial-stage organization, and continued clinical execution across multiple trials that collectively strengthen its positioning as a potential leader in neuromuscular disease therapeutics.
The most recent analyst rating on (SRRK) stock is a Buy with a $55.00 price target. To see the full list of analyst forecasts on Scholar Rock Holding stock, see the SRRK Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.