secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2026-05-13T20:01:37+00:00
Accession:  0001140361-26-021036
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BridgeBio submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels
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- NDA submitted for encaleret, a potential first approved therapy for autosomal dominant hypocalcemia type 1 (ADH1).
- Phase 3 CALIBRATE trial met all primary and key secondary endpoints: 76% on encaleret vs 4.4% on standard of care achieved both serum and urine calcium targets at Week 24 (p<0.0001).
- BridgeBio anticipates U.S. launch in early 2027; NDA may be eligible for priority review.
- Planned MAA submission to EMA in H2 2026; also plans to initiate RECLAIM-HP Phase 3 study in chronic hypoparathyroidism in Summer 2026.
- Safety profile favorable: no discontinuations in encaleret arm; low rates of serious adverse events similar between arms.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/0001140361-26-021036-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/ef20073370_form8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-021036

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