Biotech

FDA calendar: PDUFA and other FDA dates, and biotech catalysts.

The FDA decision dates, advisory committee meetings, and trial data dates drug companies have announced, with a countdown to each. The dates are the ones the companies have said in their SEC filings, and the trial registry's. They often move, and a date a company never filed is not here.

The next FDA dates

Soonest first, and small companies first: those under $5 billion with no drug on sale yet.

DateStockDrug

In 28 daysFDA decisionIn 28 days · FDA decisionINOInovio PharmaceuticalsINO-3107INOInovio Pharmaceuticals · $122MINO-3107Under FDA review
In 39 daysANDA decisionIn 39 days · ANDA decisionNRXPNRX PharmaceuticalsDrug not namedNRXPNRX Pharmaceuticals · $130MDrug not namedA generic, under FDA review
In 51 daysFDA decisionIn 51 days · FDA decisionCAPRCapricor TherapeuticsDrug not namedCAPRCapricor Therapeutics · $486MDrug not namedUnder FDA review

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8 more FDA dates and 107 trial data dates in the next 60 days. Pro members see every one, with the cash runway against each date, how each stock moved on its past FDA and trial days, and an optional alert a week before and on the day.

What these dates are

PDUFA date: The date by which the FDA has said it aims to decide on a company's application to sell a drug. The FDA can decide earlier, or extend the date.
ANDA decision date: The same kind of goal date for a generic drug's application (an ANDA), set under the generic drug program (GDUFA), not PDUFA.
Advisory committee: Outside experts meet in public to advise the FDA on an application. The FDA does not have to follow their vote.
Trial data date: The date the trial registry lists for a trial's last main measurement, as the sponsor estimates it. Results usually follow weeks to months later.

Every stock here has its own page with its trials, its cash runway, and its insiders' trades, like Inovio Pharmaceuticals (INO). Browse more drug makers on the healthcare stocks page.

The full list, with the cash behind each date.

The full list with filters by area, phase, size, and date, each company's cash runway against its date, its past reactions, and optional alerts a week before and on the day.

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Dates as the companies stated them in their SEC filings, and as the ClinicalTrials.gov registry lists them, checked Oct 2, 2026. Information, not advice; nothing here predicts an outcome.