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pdufa.bio

Eteplirsen

Updated ยทnext FDA decision on the calendar

Eteplirsen is a Sarepta Therapeutics, Inc. program. Its next catalyst is a Readout in Oct 2026. Every date links its source.

SRPT catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Sarepta Therapeutics, Inc. (SRPT). We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Readout · Oct 2026SRPT

Questions

When is Eteplirsen's next FDA decision or readout?

The next tracked catalyst for Eteplirsen is a Readout in Oct 2026.

What happened at Eteplirsen's most recent FDA decision?

No FDA decision for Eteplirsen is in our archive yet.

Who makes Eteplirsen?

Sarepta Therapeutics, Inc. (SRPT).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.