RYTM

RHYTHM PHARMACEUTICALS, INC.

FDA PDUFA Target Action Date

Saturday, December 20, 2025

157 days ago

pending

Drug Information

Drug Name: setmelanotide (CT.gov)

Filing Details

Company: RHYTHM PHARMACEUTICALS, INC. →
Stock Ticker: RYTM
SEC CIK: 0001649904
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

Explore RHYTHM PHARMACEUTICALS, INC.

View RHYTHM PHARMACEUTICALS, INC.'s full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2025-11-04. Report an issue