CAPR

Deramiocel

FDA PDUFA Target Action Date · CAPRICOR THERAPEUTICS, INC.

Sunday, November 22, 2026

63 days away

Drug Information

Drug Name: Deramiocel (CT.gov)

Filing Details

Company: CAPRICOR THERAPEUTICS, INC.
Stock Ticker: CAPR
SEC CIK: 0001133869
Source: SEC 8-K Filing →

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

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-08-24. Report an issue