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apitegromab

Scholar Rock · $SRRK
Standard Review Breakthrough Therapy Orphan Drug BLA
PDUFA Date
September 30, 2026
Time Remaining
84 days
Review Type
Standard (10 mo)
67%
Baseline PoA
Orphan/rare disease designation approval rate (prior CRL resubmission penalty applied)
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NMS

Updated just now · Data: FMP
Current Price
$56.07 +63.76%
+$21.83 today
Day: $54.98 – $57.10
Market Cap
N/A
52-Week Range
$27.07
$57.80
Current price is at 94% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

Spinal muscular atrophy (SMA), add-on to SMN-targeted therapy

Key Notes

BLA resubmitted in 2026 with FDA action expected in late September 2026 (PDUFA target near September 30, 2026). Selective myostatin inhibitor intended to improve motor function on top of nusinersen or risdiplam, based on the Phase 3 SAPPHIRE trial. First potential muscle-directed therapy in SMA. Source: Scholar Rock IR (BLA resubmission, 2026).
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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