How this calendar is built.
The biotech catalyst calendar is compiled once a day from five United States government registers. No paywalled source is used and none will be added, because the whole point of the page is that a reader can check every row against a document that is free to open. This page sets out what each source gives, what it cannot give, and what the pipeline throws away.
Last compiled .
The sources
FDA actions. Regulatory actions the FDA has already taken, plus advisory committee meetings it has formally noticed in the Federal Register. Read from FDA press announcements, the CDER Novel Drug Approvals table and the Federal Register API. Approvals are records of decisions already made. The FDA never publishes pending goal dates, so no forward PDUFA date appears here. Complete response letters are never published on this page at all.
Clinical readouts. Industry-sponsored Phase 2 and Phase 3 trials whose sponsors have told ClinicalTrials.gov to expect primary completion in the next six months. Read from The ClinicalTrials.gov v2 API, restricted to industry sponsors. A primary completion date is not a readout date. Sponsors update it lazily and it commonly runs months ahead of any press release. Every row here reports what the sponsor last told the registry, and when, and is graded estimated for that reason.
Corporate signals. Management changes disclosed under Item 5.02 of a Form 8-K, drawn from the biotech filer universe. Read from EDGAR full-text search across SIC codes 2834, 2836 and 8731. Only departures and appointments that a company chose to file. A resignation disclosed in an earnings call and never filed does not appear. This lane is built but not yet publishing.
Capital markets. Completed and announced financings, drawn from Form D and prospectus filings. Read from EDGAR Form D and 424B filings. Completed and announced raises only. This page never links to a live offering document or names an underwriter. This lane is built but not yet publishing.
Deals. Licensing agreements, collaborations and acquisitions disclosed under Item 1.01 of a Form 8-K. Read from EDGAR Item 1.01 filings and the exhibits attached to them. Disclosed terms only. Undisclosed upfronts stay undisclosed here rather than being estimated. This lane is built but not yet publishing.
How a row is written
Every sentence on the calendar is composed from structured fields lifted out of a filing: the company, the asset, the indication, the event type and the date. No sentence is copied or paraphrased from the wording of a source. That is partly a copyright decision and partly an accuracy one, because a paraphrase quietly imports the source’s confidence along with its facts.
Each sentence carries the date on which the claim was made. A row reading “as of 1 April 2026, the sponsor estimated primary completion in August” stays true in September. A row reading “data expected in August” does not. The distinction matters because an answer engine quoting this page strips the confidence grade and the provenance link, leaving only the sentence.
The three confidence grades
Confirmed means a government body has stated the fact itself. An approval announced by the FDA is confirmed. So is an advisory committee meeting noticed in the Federal Register.
Guided means a company has stated the date in a filing, in its own words, and is on the record for it.
Estimated means a date a sponsor entered in a registry field and can revise at any time without telling anyone. Almost every forward row on this calendar is estimated, and pretending otherwise would be the single easiest way to make the page wrong.
What is refused
Complete response letters are never published here, in any lane, ever. A false report that a company received one is materially adverse, stock moving and close enough to trade libel that no automated pipeline should be near it. Live offerings are refused on the same principle: completed and announced financings only, never a link to an offering document and never the name of an underwriter.
Companies that are advisory clients are suppressed from the calendar automatically. The suppression is recorded in the drop log rather than applied silently.
What was dropped
In the last 30 days the gates rejected 48 candidate rows that a source offered. The reasons, in order:
| Reason | Rows |
|---|---|
| The composed sentence ran past the length limit | 48 |
Known limits
There is no free forward calendar of FDA action dates anywhere, including on FDA.gov. The agency does not publish pending goal dates. Every commercial calendar that shows them has read them out of company filings by hand. This calendar does not show them yet, and says so rather than filling the gap with guesses.
The FDA’s approval announcements never name the sponsor, so some rows carry a drug and no company. The oncology announcement feed has been dead since January 2025. EDGAR’s full-text search silently ignores industry filters, so the filer universe is rebuilt weekly instead. None of these are bugs in the pipeline. They are the shape of the public record.
Reuse
The calendar is published under CC BY 4.0. Take it, republish it, feed it to a model. Attribution is the only condition. Bulk copies are available as JSON, CSV and iCalendar.