Scholar Rock Holding (SRRK)
NASDAQ:SRRK
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Scholar Rock Holding
(NASDAQ:SRRK)
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Rating:56Neutral
Price Target:
$50.00
▲(0.08% Upside)
Action:Reiterated
Date:05/09/26
The score is held down primarily by very weak financial performance (no revenue, widening losses, and substantial cash burn with rising debt). Offsetting this, the earnings call highlighted meaningful regulatory progress and launch preparation (accepted BLA with a defined PDUFA date and dual manufacturing path), while technicals show a moderate uptrend. Valuation provides limited support given negative earnings and no dividend data.
Positive Factors
Regulatory progress: BLA acceptance & PDUFA
Acceptance of the BLA and a defined PDUFA date materially reduce timing uncertainty and create a clear regulatory path to commercialization. A favorable decision would transition Scholar Rock from a clinical-stage spender to a potential revenue generator and unlock milestone/financing triggers.
Negative Factors
No product revenue and widening losses
The company remains unprofitable with no product revenue and rapidly increasing net losses. Persistent, large negative earnings and cash consumption mean the business cannot self-fund operations long-term without successful approval, commercialization or sustained external financing.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory progress: BLA acceptance & PDUFA
Acceptance of the BLA and a defined PDUFA date materially reduce timing uncertainty and create a clear regulatory path to commercialization. A favorable decision would transition Scholar Rock from a clinical-stage spender to a potential revenue generator and unlock milestone/financing triggers.
Read all positive factors
Scholar Rock Holding (SRRK) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$5.91B
Dividend YieldN/A
Average Volume (3M)1.30M
Price to Earnings (P/E)―
Beta (1Y)1.62
Revenue GrowthN/A
EPS Growth-35.59%
CountryUS
Employees128
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-3.45
Shares Outstanding119,828,340
10 Day Avg. Volume1,248,838
30 Day Avg. Volume1,299,955
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 Cap0.96
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-7.56K
Enterprise Value/Ebitda-14.25
Forecast
1Y Price Target
$60.17Price Target Upside20.43% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering15
EPS Forecast (FY)-3.19
Revenue Forecast (FY)$6.42M
Scholar Rock Holding Business Overview & Revenue Model
Company Description
Scholar 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 ...
How the Company Makes Money
Scholar Rock primarily generates revenue through collaboration and licensing arrangements rather than product sales, as it is a clinical-stage company and does not consistently have commercialized products. Key revenue streams typically include (1...
Scholar Rock Holding Earnings Call Summary
Earnings Call Date:May 07, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 12, 2026
Earnings Call Sentiment Positive
The call conveyed strong positive momentum: FDA accepted the BLA with a clear PDUFA date (Sept 30, 2026), the company has created dual manufacturing paths (second facility supplying product in early Q3), European review appears on track for midyear, and the balance sheet and commercial infrastructure were strengthened during the quarter. Key risks remain focused on regulatory classification of the Catalent Indiana site, continued manufacturing/regulatory uncertainty until that classification, high pre-commercial operating spend, and the need to monetize financing levers (debt/ATM/PRV). On balance, the material positive developments (BLA acceptance, dual fill-finish strategy, clear supply path, strong cash position, pipeline progression and commercial readiness) outweigh the remaining lowlights and uncertainties.Positive Updates
FDA Accepts BLA and Sets PDUFA Date
FDA accepted Scholar Rock's biologics license application for apitegromab for children and adults with SMA and assigned a PDUFA action date of September 30, 2026. The accepted BLA includes two fill-finish facilities, providing dual independent paths to potential approval.
Negative Updates
Manufacturing-Related Approvability Risk Remains
A prior complete response letter (Sept 2025) flagged Catalent Indiana site observations as the sole approvability issue. Although a reinspection was completed, the FDA has up to 90 days to classify the facility — regulatory uncertainty on Catalent persists until classification is issued.
Read all updates
Q1-2026 Updates
Positive
Negative
FDA Accepts BLA and Sets PDUFA Date
FDA accepted Scholar Rock's biologics license application for apitegromab for children and adults with SMA and assigned a PDUFA action date of September 30, 2026. The accepted BLA includes two fill-finish facilities, providing dual independent paths to potential approval.
Read all positive updates
Company Guidance
Management reiterated that the FDA has accepted the apitegromab BLA with a PDUFA action date of September 30, 2026, filed with two fill‑finish sites (Catalent Indiana, which underwent an unannounced reinspection and for which the FDA has up to 90 days to classify, and a second U.S. facility whose drug product has been filed and is expected to supply ample commercial drug in early Q3), the EMA MAA is progressing with a CHMP opinion expected near mid‑year and a planned Europe launch in H2 beginning in Germany; balance sheet and financing metrics include $480 million in cash, cash equivalents and marketable securities at quarter end, a $100 million debt draw in March, $98 million of net ATM proceeds in Q1, an option to draw an additional $150 million upon FDA approval and plans to monetize a priority review voucher; Q1 operating expenses were $102 million (including $80 million noncash stock‑based compensation; $84 million ex‑SBC); commercial readiness and market metrics cited were reach to ~140 SMA treatment centers and ~2,600 prescribing physicians, access to ~10,000 home‑infusion nurses, an expanded specialty pharmacy network, an addressable SMA population of up to ~35,000 patients globally who have received ≥1 SMN therapy (with ~1/3 of U.S. patients having received ≥2 SMN therapies and ~95% still experiencing persistent/progressive muscle atrophy); and pipeline milestones included ongoing enrollment in the Phase II OPAL study (infants/toddlers <2), initiation of the randomized Phase II FORGE FSHD trial (n=60) mid‑year, Phase I subcutaneous apitegromab with favorable bioavailability, and SRK‑439 Phase I dosing with topline data expected later this year.Scholar Rock Holding Financial Statement Overview
Summary
Income Statement
12
Very Negative
Balance Sheet
48
Neutral
Cash Flow
18
Very Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 33.19M | 18.82M |
| Gross Profit | -752.00K | 0.00 | -1.94M | -2.84M | -89.85M | -89.65M |
| EBITDA | -398.89M | -369.39M | -237.52M | -162.94M | -129.48M | -127.29M |
| Net Income | -408.73M | -377.94M | -246.29M | -165.79M | -134.50M | -131.80M |
Balance Sheet | ||||||
| Total Assets | 535.25M | 404.27M | 474.92M | 311.04M | 358.17M | 304.44M |
| Cash, Cash Equivalents and Short-Term Investments | 479.94M | 367.56M | 437.28M | 279.94M | 315.36M | 252.99M |
| Total Debt | 205.67M | 108.92M | 65.13M | 61.82M | 69.40M | 84.47M |
| Total Liabilities | 259.24M | 158.78M | 106.29M | 85.82M | 97.93M | 132.37M |
| Stockholders Equity | 276.01M | 245.49M | 368.63M | 225.22M | 260.24M | 172.07M |
Cash Flow | ||||||
| Free Cash Flow | -303.86M | -300.64M | -201.05M | -145.30M | -133.76M | -132.04M |
| Operating Cash Flow | -303.46M | -300.04M | -200.95M | -145.23M | -132.69M | -126.79M |
| Investing Cash Flow | 178.80M | 218.69M | -76.06M | 41.14M | -171.70M | 134.31M |
| Financing Cash Flow | 418.02M | 228.40M | 353.03M | 102.57M | 194.83M | 44.95M |
Scholar Rock Holding Technical Analysis
Positive
49.96
Price Trends
47.80
Positive
46.37
Positive
41.26
Positive
Market Momentum
0.62
Negative
53.21
Neutral
63.32
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 49.96 is above the 20-day moving average (MA) of 48.54, above the 50-day MA of 47.80, and above the 200-day MA of 41.26, indicating a bullish trend. The MACD of 0.62 indicates Negative momentum. The RSI at 53.21 is Neutral, neither overbought nor oversold. The STOCH value of 63.32 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 "Finance & Corporate" 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 |
|---|---|---|---|---|---|---|---|
62 Neutral | $5.29B | -12.48 | -49.23% | ― | -100.00% | -46.29% | |
62 Neutral | $6.84B | -13.42 | -68.16% | ― | ― | -1.22% | |
56 Neutral | $5.91B | -15.35 | -163.52% | ― | ― | -35.59% | |
56 Neutral | $3.94B | -19.17 | -29.80% | ― | -52.13% | 3.91% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $2.36B | -3.95 | 1566.94% | ― | 13.33% | -3.82% | |
45 Neutral | $3.80B | -8.01 | -71.31% | ― | ― | -259.98% |
* Healthcare Sector Average
SRRK
Scholar Rock Holding
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Scholar Rock Holding Corporate Events
Business Operations and StrategyFinancial DisclosuresPrivate Placements and FinancingRegulatory Filings and Compliance
Scholar Rock Advances Apitegromab Toward Potential 2026 Launches
Positive
May 7, 2026
Scholar Rock on May 7, 2026 reported first-quarter 2026 results and recent milestones, highlighting FDA acceptance of its Biologics License Application for apitegromab in spinal muscular atrophy with a Sept. 30, 2026 PDUFA action date and ongoing ...
Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Scholar Rock Resubmits Apitegromab BLA, Expands Manufacturing Plans
Positive
Mar 31, 2026
On March 31, 2026, Scholar Rock announced it had resubmitted its biologics license application to the U.S. Food and Drug Administration for apitegromab, a first-in-class muscle-targeted therapy that has shown statistically significant and clinical...
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 i...
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.