Adverse FDA regulatory actions disclosed in 8-Ks: Complete Response Letters,

Adverse FDA regulatory actions disclosed in 8-Ks: Complete Response Letters, full and partial clinical holds, and refuse-to-file letters, 2024+, each graded by an explicit severity precedence rule with the evidence flags the grade depends on served alongside it (new-trial-required, manufacturing-related, resubmission-path, hold-lifted). Follow-ups and resolutions are linked per (issuer, drug program), so an original hold row answers 'was it ever lifted, and how long did it take'.

By default only classified FDA events are returned (~196 rows); the ~1,520 audited not-an-event rows the full-text sweep also retrieved are available with include_rejects=true. The date window filters disclosed_date (the EDGAR filing date); event_letter_date is extracted with its own precision enum and days_letter_to_disclosure is the selective-disclosure measure -- on initial_disclosure rows only (on follow-ups it measures distance to the original letter). Selective disclosure is the headline caveat: a CRL disclosed only in a 10-Q, or never, is not here.

Requires an Alphanume Pro API key. A 403 PRO_SUBSCRIPTION_REQUIRED or DATE_RANGE_RESTRICTED error means the key's plan does not cover the request -- it does not mean the data is missing.

get/v1/biotech/fda-response-events

Request

  • Base URL: https://api.alphanume.com
  • URL: https://api.alphanume.com/v1/biotech/fda-response-events
  • Auth: one of:
    • API key in header X-API-Key
    • HTTP bearer

Query parameters

tickerstring

Ticker symbol filter, e.g. 'AAPL'. Case-insensitive.

cikstring

SEC CIK number (digits only).

event_typestring

Comma-separated: crl, clinical_hold_full, clinical_hold_partial, refuse_to_file, other_fda_action. (not_a_setback_event requires include_rejects=true.)

filing_rolestring

What the document does about the event: initial_disclosure, follow_up_update, or resolution. Counting rows without this filter overstates events ~2.4x -- one program's hold can be 3+ filings.

severitystring

Comma-separated severity grades: program_terminated, major_delay_new_trial_required, manufacturing_only, addressable_deficiencies, safety_signal_no_path_stated, unstated, not_restated. Rank encodes grading precedence, NOT market impact.

resolvedstring

true = events with a linked later resolution (hold lifted, approval, resubmission accepted); false = still open. NULL rows are themselves resolutions.

include_rejectsstring

true = include the ~1,520 audited 'not_a_setback_event' rows (boilerplate the recall-first sweep retrieved and the labeler rejected, each with its reason). Default = real FDA events only.

drug_searchstring

Case-insensitive substring on the drug/asset name (3+ chars).

asset_keystring

Exact normalized program key -- groups all filings about one program and audits the served linkage columns.

datestring

Exact date, YYYY-MM-DD. Cannot be combined with the date range parameters.

date_gtestring

Start of date range, inclusive (YYYY-MM-DD).

date_ltestring

End of date range, inclusive (YYYY-MM-DD).

date_gtstring

Start of date range, exclusive (YYYY-MM-DD).

date_ltstring

End of date range, exclusive (YYYY-MM-DD).

updated_sincestring

YYYY-MM-DD, on last_updated -- rows touched by the linkage sweep since this date.

cursor_datestring

Pagination: 'date' from next_cursor (send with cursor_accession).

cursor_accessionstring

Pagination: 'accession_number' from next_cursor (send with cursor_date).

Response

Matching rows.

countinteger required
dataobject[] required
has_moreboolean required
next_cursorobject nullable required

Keyset cursor: pass its fields back as the cursor_* query parameters to fetch the next page.

Changes

No recorded changes to this operation across all 1 revision of this API.