secwatch / observer

8-K filed May 27, 2026, 4:01 PM ET ticker BBIO CIK 0001743881

regulatory confidence high sentiment positive materiality 0.85

FDA accepts NDA for BBP-418 with Priority Review; PDUFA Nov 27, 2026

BridgeBio Pharma, Inc.

FDA accepted NDA with Priority Review for BBP-418 to treat LGMD2I/R9; PDUFA target action date November 27, 2026.
No advisory committee meeting currently planned for the application.
Phase 3 FORTIFY trial met all primary and secondary endpoints; treated patients improved while placebo declined.
If approved, BBP-418 would be first and only therapy for LGMD2I/R9 and first approved treatment for any form of LGMD.
BridgeBio plans to start studies in patients under 12 years and in LGMD2M/R13 and LGMD2U/R20.

item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001140361-26-022979
form_type: 8-K
ticker: BBIO
cik: 0001743881
company_name: BridgeBio Pharma, Inc.
filed_at: 2026-05-27T20:01:34+00:00
discovered_at: 2026-05-27T20:03:00.329169+00:00
generated_at: 2026-05-27T20:06:43.574075+00:00
sec_items: ["8.01", "9.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: high
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json_url: https://secwatch.observer/filing/0001140361-26-022979.json
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review_status: machine_generated
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