How to verify a catalyst date yourself on SEC EDGAR

Every row on this site links to a source, and most of those sources are filings on the SEC's EDGAR system. You don't need to trust us, or any catalyst calendar, for a date: you can find and read the filing yourself in a few minutes, for free. This is the same method we use, including the mistakes it catches.

Why EDGAR is the place to look

The FDA doesn't publish pending PDUFA dates, and clinical readout timing exists only as company guidance. So the company is the only primary source, and a listed company's material announcements end up on EDGAR: US companies file a Form 8-K, foreign ones a Form 6-K, usually with the press release attached as Exhibit 99.1. (8-K vs 6-K vs press release explains the differences.) A filing has a fixed date and a permanent address, and it can't be quietly edited afterwards. That makes it a better source than a web page or a calendar.

Step 1: Find the company's filings

Go to EDGAR search and type the company name or ticker. The company page lists every filing, newest first. Use the filter to show only 8-K (or 6-K) filings. For a quick scan, each 8-K's description lists the items it reports: Item 2.02 is a results release, and Items 7.01 and 8.01 are where most other news goes.

Every company has a permanent ID, its CIK. You can see it in any filing address: in sec.gov/Archives/edgar/data/1133869/…, the CIK is 1133869 (Capricor).

Step 2: Or search the words instead

EDGAR's full-text search, the "Document word or phrase" box on the same search page, searches the text of filings from 2001 onwards. Put phrases in quotes. The phrases that reliably appear when a company discloses a regulatory date are:

"PDUFA target action date" and "PDUFA date of"
"target action date of"
"accepted for filing", the announcement that usually carries the new date
"Advisory Committee meeting"
"Complete Response Letter", for outcomes

Add the company name, limit the form type to 8-K and 6-K, and set a date range. Our weekly scan runs these same searches automatically across all companies. The scan only finds candidate filings. It never decides what a date is; a person reads each one.

Step 3: Open the right document

Clicking a filing opens its index page, which lists the documents in it. The 8-K itself is usually a short cover form saying which items it reports. The substance is normally in Exhibit 99.1, the press release. Sometimes a second exhibit (99.2) holds an investor presentation, which is where readout windows tend to appear as a timeline slide.

A filing's address tells you what it is. In /Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm, the middle number is the accession number, 0001104659-26-100071. The first part identifies whoever submitted it (often a filing agent, not the company), "26" is the year, and the rest is a sequence. The file name ends in "ex99d1", Exhibit 99.1.

Step 4: Read the sentence, not the headline

Use your browser's find (Ctrl+F) for "PDUFA", "target action", "topline", "expect" or "anticipate", and read the whole sentence it's in. Check:

Which drug and which indication? A company may have several applications at once.
Whose date is it? The FDA's goal date ("the FDA assigned a PDUFA target action date of…") is a commitment. The company's own hope ("we anticipate approval in the first half of 2027") is not.
How precise is it? A day, a month, a quarter, a half or a year. Write it down at the precision given and no tighter.
Is there more than one date? "Extended from August 22 to November 22" contains a dead date and a live one.
When was it filed? The filing date is on the index page. A date that was right in May may have moved by August.

A trap the filing catches

Catalyst calendars listed Cogent's 30 November 2026 PDUFA date against bezuclastinib in systemic mastocytosis. The company's own 8-K exhibit of 10 August 2026 shows that date is for gastrointestinal stromal tumours (GIST), and that non-advanced systemic mastocytosis has a separate date of 30 December 2026. Same drug, two applications, and only the filing gets them the right way round. See the Cogent page.

A trap the filing catches

CG Oncology's filing said a Phase 3 topline result was "anticipated in the near-term" without naming a window. Any date you see for it is someone's guess, so our row is marked Needs check and the note says the year shown is a placeholder, not company guidance (CG Oncology page).

Step 5: Look for anything newer

Dates move: reviews get extended, applications get resubmitted, readouts slip. Before relying on a date, scan the company's filing list for anything filed after your source. The quarterly report (10-Q, or 10-K for the full year) and the matching results release usually restate every upcoming milestone, which makes them a good place to confirm that guidance hasn't changed.

From the tracker

Capricor's deramiocel had a PDUFA date of 22 August 2026 until its 8-K of 24 August reported a three-month extension to 22 November. Anyone working from an earlier filing would have been watching a date that had already passed. See the Capricor page.

Step 6: Cross-check where you can

Some catalysts can be confirmed from a second, independent source:

Advisory committee meetings are on the FDA's advisory committee calendar and in the Federal Register.
Approvals appear on Drugs@FDA and, for new drugs, the FDA's novel approvals list. Complete Response Letters are now published on openFDA.
Trials have a record on ClinicalTrials.gov. Its "primary completion date" is a planning estimate the sponsor enters, not a readout date, so treat it as context rather than confirmation.

What our status labels mean in these terms

Verified: someone did steps 3 and 4, read the sentence in the linked filing, and it says what the row says.
Auto-extracted: the linked document is primary and the sentence is quoted, but no person has done step 4 yet.
Reported: the date came from a secondary source such as a catalyst calendar, and the company's own filing hasn't been found or read yet.
Needs check: step 4 found something ambiguous, explained in the row's note.

The full process is on the methodology page. If you follow these steps and find a row that doesn't match its filing, please tell us.

More guides

What a PDUFA date is, and why the FDA doesn't publish themThe PDUFA target action date is the FDA's own deadline for deciding on a drug application. Here is where it comes from, how it moves, and why you only hear about it from the company.
What happens at an FDA advisory committee meetingWho sits on an FDA advisory committee, how the day runs, what the vote means and doesn't mean, and where to find the documents beforehand.
What a Complete Response Letter means, and what usually followsA Complete Response Letter is the FDA's "not yet" on a drug application. What it contains, the company's options, how resubmission clocks work, and how to read the announcement.
How to read a Phase 3 topline readoutEndpoints, p-values, effect sizes, safety tables and the phrase "met its primary endpoint": a practical guide to reading the press release a company puts out when pivotal trial results land.
Clinical trial phases explained: Phase 1 to Phase 4What each phase of clinical development is for, roughly how big the trials are, what the in-between labels like 1b, 2a and 2/3 mean, and what a readout at each stage can and can't tell you.
NDA vs BLA: the two kinds of US drug applicationWhy some products are filed as a New Drug Application and others as a Biologics License Application, who reviews each, what supplements and rolling submissions are, and why the difference matters after approval.
Fast Track, Breakthrough, Priority Review and Accelerated Approval explainedThe FDA's expedited programmes are often lumped together, but they do different things at different stages. What each one is, what it changes about the timeline, and what it doesn't promise.
8-K vs 6-K vs press release: where catalyst dates are disclosedWhy almost every row on this site links to an 8-K exhibit, what the 6-K is for, when a press release has no filing behind it, and how the item numbers and "furnished vs filed" affect what you're reading.
Why catalyst windows like "H2 2026" are vague, and how they narrowMost biotech catalysts don't have a date, only a window the company guided to. Why that is, what the common phrases mean, how windows tighten or slip, and how this site handles them.
Glossary of FDA and biotech catalyst termsPlain-English definitions of the regulatory, clinical and SEC-filing terms used across the tracker and the guides, from AdComm to Type A meeting.