SRRK

apitegromab

FDA PDUFA Target Action Date · Scholar Rock Holding Corp

Wednesday, September 30, 2026

10 days away

Drug Information

Drug Name: apitegromab (CT.gov)
Application Type: BLA
Indication: spinal muscular atrophy (SMA)

Filing Details

Company: Scholar Rock Holding Corp →
Stock Ticker: SRRK
SEC CIK: 0001727196
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore Scholar Rock Holding Corp

View Scholar Rock Holding Corp's full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue