secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2026-07-22T20:34:14+00:00
Accession:  0001140361-26-029291
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BridgeBio announces FDA acceptance of NDA for encaleret in ADH1; PDUFA date May 8, 2027
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- FDA accepted NDA for encaleret for ADH1; PDUFA target action date May 8, 2027; no advisory committee planned.
- Encaleret met all primary and key secondary endpoints in Phase 3 CALIBRATE trial, normalizing CaSR-driven markers.
- Over 2,100 ADH1 patients diagnosed in U.S. since Oct 2023; BridgeBio plans MAA submission to EMA in H2 2026.
- Company also enrolling pediatric Phase 2/3 (CALIBRATE-PEDS) and plans Phase 3 in chronic hypoparathyroidism (RECLAIM-HP).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/0001140361-26-029291-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/ef20078442_form8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-029291

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer