1 FDA goal date change on record in this archive, newest first. Each row states the date it moved from, the date it moved to, and links the announcement that said so. A PDUFA date is the FDA's target for completing review, and the agency can extend it, most often by three months after a major amendment.
Recorded changes
CAPR · Deramiocel (CAP-1002) - (HOPE-3)
Goal date moved from Aug 22, 2026 to Nov 22, 2026, 92 days later, announced by Capricor Therapeutics Inc.. Source. CAPR events.
What this list is: every goal-date change this archive recorded, not every change the FDA made. Changes that happened before we tracked an application, or that were never announced publicly, are absent. Updated September 6, 2026.
Questions
Why do PDUFA dates change?
The FDA can extend a goal date, most often by three months, when the sponsor submits a major amendment to the application during review. A sponsor may also withdraw and resubmit, which starts a new review clock. The agency does not publish these changes as a list; each one here comes from the company's own announcement.
Is this every PDUFA date change?
No. It is every change THIS ARCHIVE recorded, currently 1. A goal date that moved before we began tracking the application, or that moved without a public announcement, is not here. We would rather show a short sourced list than imply a complete one.
Where do the dates come from?
Company press releases and SEC filings, linked on every row. pdufa.bio is never cited as its own source.
Historical record of specific date changes, each linked to its source. Not a prediction about any pending application, and not investment advice.