Scholar Rock Holding (SRRK)
NASDAQ:SRRK
Want to see SRRK full AI Analyst Report?
Earnings Data
Report Date
Aug 12, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.84Last Year’s EPS
-0.98Same Quarter Last Year
Strong Buy
Based on 15 Analysts Ratings
Earnings Call Summary
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.Company Guidance
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.
Dual Fill-Finish Strategy and Supply Progress
All apitegromab drug product required for FDA review has been filed from the second U.S.-based fill-finish facility; company expects ample commercial apitegromab from that facility in early Q3 2026 (ahead of the Sept 30 PDUFA date). FDA completed an unannounced reinspection of Catalent Indiana and has up to 90 days to classify the site, creating multiple supply/approval pathways.
European Review Advancing
MAA review in Europe is progressing well; Scholar Rock expects a CHMP opinion near midyear 2026 and anticipates a European launch in H2 2026 beginning with Germany.
Strong Cash Position and Near-Term Financing Optionality
Ended Q1 2026 with $480 million in cash, cash equivalents and marketable securities. Q1 activity included a $100 million drawdown from an existing debt facility (March) and $98 million net proceeds from the ATM program. Company has an option to draw an additional $150 million upon FDA approval and plans to monetize a priority review voucher.
Commercial Launch Readiness
U.S. commercial team positioned to launch immediately upon approval; established reach across ~140 SMA treatment centers and ~2,600 prescribing physicians; built patient services program (Scholar Rock Supports), expanded specialty pharmacy network and arranged >10,000 home infusion nurses via partners.
Pipeline Advancement — Multiple Programs
Ongoing enrollment and dosing in Phase II OPAL (infants/toddlers <2 yrs); FORGE randomized Phase II in FSHD planned to initiate midyear with a 60-patient sample size; subcutaneous apitegromab Phase I showed favorable bioavailability and comparable PD to IV; SRK-439 (high potency anti-myostatin) dosing in Phase I healthy volunteers is progressing with topline data expected later in 2026.
Clear Clinical Need and Market Opportunity
Company highlighted persistent unmet need: ~95% of SMA patients continue to experience progressive muscle atrophy; Cure SMA data indicate ~33% of people with SMA in the U.S. have received 2+ SMN-targeted treatments. Scholarship Rock estimates addressing up to ~35,000 patients globally who have received at least one SMN-targeted therapy.
SRRK Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
SRRK Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 07, 2026 | $47.11 | $46.45 | -1.40% |
Mar 03, 2026 | $43.48 | $44.31 | +1.91% |
Nov 14, 2025 | $30.07 | $37.41 | +24.41% |
Aug 06, 2025 | $36.98 | $34.62 | -6.40% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Scholar Rock Holding (SRRK) report earnings?
Scholar Rock Holding (SRRK) is schdueled to report earning on Aug 12, 2026, After Close (Confirmed).
What is Scholar Rock Holding (SRRK) earnings time?
Scholar Rock Holding (SRRK) earnings time is at Aug 12, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is SRRK EPS forecast?
SRRK EPS forecast for the fiscal quarter 2026 (Q2) is -0.84.
