BridgeBio Pharma, Inc.
encaleret
autosomal dominant hypocalcemia type 1 (ADH1)
Countdown
177days
FDA decision · ~ Dec 31, 2026 estimated
What's at stake
The FDA's approval decision on encaleret for autosomal dominant hypocalcemia type 1 (ADH1) is due ~ Dec 31, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“BridgeBio has successfully completed a pre-NDA interaction and intends to submit an NDA to the FDA in the first half of 2026, and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) to follow.”