secwatch.observer — SEC 8-K summary
======================================

Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2024-11-25T23:59:59+00:00
Accession:  0001140361-24-047704
Event type: regulatory
Sentiment:  positive
Materiality: 1.00
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves BridgeBio's Attruby (acoramidis) for ATTR-CM to reduce CV death and hospitalization
--------------------------------------------------------------------------------

- Attruby is first and only approved TTR stabilizer with label specifying near-complete stabilization (≥90%).
- Phase 3 ATTRibute-CM: 42% reduction in composite ACM and recurrent CVH at Month 30; 50% reduction in cumulative CVH events.
- BridgeBio to receive $500M payment under royalty funding agreement upon approval.
- List price: $18,759.12 for 28-day supply; free for life for U.S. trial participants.
- MAA submitted to EMA; decision expected in 2025; Bayer has exclusive EU commercialization rights.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036124047704/0001140361-24-047704-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036124047704/ef20039071_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-047704

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