Low-dose infigratinib - (PROPEL3)
- Indication
- Achondroplasia
- Stage
- phase4
- Event
- Submission
- Details
August 10, 2026: BridgeBio Pharma (NASDAQ: BBIO) reported Q2 2026 results and a pipeline/regulatory update. Attruby (acoramidis) for ATTR-CM generated $222.4 million in U.S. net product revenue ($243.7 million total revenue). New analyses published in Circulation: Heart Failure showed an early reversible eGFR dip, placebo-corrected 15.5% UACR reduction by Day 28, improved chronic eGFR slope (+2.47 mL/min/1.73m²/year), and 13.7% UACR reduction through Month 30; larger eGFR dips were associated with 58% lower risk of death or CV hospitalization in year one. At Heart Failure 2026, acoramidis reduced outpatient worsening heart failure risk by 41% vs placebo. Real-world data from 286 matched pairs in TriNetX showed 37% lower composite CV events (HR 0.63, p=0.002) and 34% fewer hospitalizations (HR 0.67, p=0.002) vs tafamidis at six months. More data are planned at ESC 2026.
BBP-418 for LGMD2I/R9: NDA accepted with Priority Review; FDA PDUFA November 27, 2026; no AdCom planned.
Encaleret for ADH1: NDA accepted with Priority Review; PDUFA May 8, 2027; no AdCom planned; MAA submitted to EMA. RECLAIM-HP Phase 3 in chronic hypoparathyroidism has begun screening; topline data expected late 2027/early 2028.
Oral infigratinib for achondroplasia: NDA submitted to FDA; MAA planned in Q4 2026. Phase 3 PROPEL 3 met its primary endpoint (height velocity, p<0.0001) and improved arm span Z-score (+0.37 SD, p<0.0001). A Phase 2 hypochondroplasia update is expected in 2H 2026. BridgeBio reported $720.2 million in cash as of June 30, 2026, excluding a $1 billion preferred equity financing that closed July 1, 2026.
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