secwatch / observer

8-K filed May 13, 2026, 4:01 PM ET ticker BBIO CIK 0001743881

regulatory confidence high sentiment positive materiality 0.80

BridgeBio submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels

BridgeBio Pharma, Inc.

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.

item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001140361-26-021036
form_type: 8-K
ticker: BBIO
cik: 0001743881
company_name: BridgeBio Pharma, Inc.
filed_at: 2026-05-13T20:01:37+00:00
discovered_at: 2026-05-13T20:03:00.785430+00:00
generated_at: 2026-05-13T22:24:51.001426+00:00
sec_items: ["8.01", "9.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: high
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json_url: https://secwatch.observer/filing/0001140361-26-021036.json
markdown_url: https://secwatch.observer/filing/0001140361-26-021036.md
text_url: https://secwatch.observer/filing/0001140361-26-021036.txt
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review_status: machine_generated
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correction_note: null
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