secwatch.observer — SEC 8-K summary ====================================== Issuer: BridgeBio Pharma, Inc. (BBIO) CIK: 0001743881 Form: 8-K Filed at: 2024-11-12T23:59:59+00:00 Accession: 0000950170-24-124576 Event type: earnings Sentiment: neutral Materiality: 0.80 Item codes: 2.02, 9.01 LLM model: deepseek-v4-flash:cloud@v2 BridgeBio posts Q3 net loss of $162M; acoramidis PDUFA set for Nov 29, 2024 --------------------------------------------------------------------------- - Net loss per share of $0.86; revenue $2.7M vs $4.1M YoY; operating expenses $194.5M. - Cash, equivalents, and short-term restricted cash $405.7M; expects $500M milestone from acoramidis upon FDA approval. - FDA accepted acoramidis NDA; PDUFA date November 29, 2024; 42-month OLE data to be presented at AHA. - FDA granted Breakthrough Therapy Designation to oral infigratinib for achondroplasia. - Phase 3 FORTIFY trial for LGMD2I/R9 enrollment completed; interim analysis expected in 2025. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1743881/000095017024124576/0000950170-24-124576-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1743881/000095017024124576/bbio-20241112.htm HTML page: https://secwatch.observer/filing/0000950170-24-124576 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer