FDA Decision Calendar

Dates in Motion

Reviews where the published date no longer stands and no replacement has been set. They stay here rather than being given a guessed date.

• Extension pending; was August 22, 2026CAPR: deramiocelExtension pending

  Capricor Therapeutics · BLA (Class 2 resubmission, amendment in progress) · Duchenne muscular dystrophy (label being narrowed to upper limb dysfunction)

  Was: August 22, 2026

  Advisory committee: Advisory committee voted 3-9 against on July 29, 2026, on the cardiomyopathy framing.

  Capricor said on its August 13 call that it will amend the BLA to cover upper limb dysfunction only, and that the FDA indicated the August 22 action date will be extended once the amendment is received. No new date has been set; a major amendment normally adds three months, but the classification has not been stated.

  Parent Project MD account of the FDA's extension signal (August 13, 2026) ↗ · Capricor Q2 2026 release (August 13, 2026) ↗ · Our coverage: capricor capr deramiocel fda decision august 22 preview, why capricor capr stock rose 58 percent fda decision delayed

How This Is Built

A date only appears here once it has been read in the company's own press release or filing, linked on the row. Aggregator calendars are used to find candidates and never to establish a date, because they demonstrably lag extensions: on the day this page launched, two syndicated dates were three months and one month stale respectively. When the FDA extends a review, the row keeps both dates, so a reader who saw the old one can see what happened to it.

The calendar deliberately covers a curated set: decisions on names this site covers, plus the largest pending approvals. It is not an exhaustive list of every generic and supplemental application, and it does not need to be to answer the question readers bring to it.

The whole calendar is available as JSON and CSV, licensed CC BY 4.0, with the source link and status carried on every row.

PDUFA Date FAQ

When is the next FDA decision date?

RARE (Ultragenyx Pharmaceutical): the FDA's target action date for DTX401 (pariglasgene brecaparvovec) in glycogen storage disease type ia, aav gene therapy is August 23, 2026. A PDUFA date is a deadline for the FDA to act, not a promise of approval: the agency can approve, issue a complete response letter, or extend the review.

What is a PDUFA date?

The date by which the FDA has committed to act on a drug application, under the Prescription Drug User Fee Act. Standard review targets ten months from acceptance; priority review targets six. The FDA can approve, reject with a complete response letter, or extend the date, most commonly by three months when a late submission is classed as a major amendment.

Do FDA decisions arrive exactly on the PDUFA date?

No. The date is a by-date, not an on-date: decisions regularly land days or weeks early, and dates that fall on a weekend resolve by the preceding business day in practice. Approvals have also arrived after the stated date without any formal extension.

Why do dates on this calendar differ from other FDA calendars?

Because extensions move dates and most aggregators are slow to catch them. When this calendar launched, two of the widely syndicated dates were stale: Savara's molgramostim had been extended from August 22 to November 22, 2026, and Cogent's bezuclastinib date is December 30, 2026, per the company, not the November 30 some calendars carry. Every date here links the company press release that set it. Last updated August 19, 2026.

What happens to a stock on a PDUFA date?

A binary event: approval opens a commercial launch, a complete response letter sends the company back for more work, and the stock reprices on whichever arrives. The move is usually largest for single-asset companies where the drug is most of the market cap, and smallest for label expansions on already-approved drugs at large companies.