BridgeBio reports positive Phase 3 topline results for encaleret in ADH1

The CALIBRATE Phase 3 study met all primary and key secondary endpoints, showing 76% of patients on encaleret achieved both serum and urine calcium targets versus 4% on conventional therapy. NDA submission is now planned for the first half of 2026 to support full approval.

Key facts

Filed: Oct 29, 2025, 08:09 PM
Event: Topline results
Direction: Positive
Company: BBIOBridgeBio
Asset: acoramidis
Source: SEC 8-K
Confidence: Sourced
ahv ls mean diff: +1.74 cm/yr (p<0.0001)
ahv observed mean diff: +2.10 cm/yr (p<0.0001)
hyperphosphatemia cases: 3 (4%), all mild/transient/asymptomatic
height z score ls mean increase: +0.41 SD (p<0.0001)
body proportionality ls mean diff: -0.05 (p<0.05) in ages 3-8
arm span z score ls mean improvement: +0.37 SD (p<0.0001)

Source excerpt

EX-99.1 2 ef20057894_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 BridgeBio Reports Positive Phase 3 Topline Results for Encaleret in Patients with Autosomal Dominant Hypocalcemia Type 1 - The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints - The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001) - In a key secondary analysis, 91% of participants administered encaleret achieved intact PTH above the lower limit of the reference range at Week 24 compared to 7% of participants when on conventional therapy at Week 4 (p<0.0001) - Encaleret was well-tolerated with no discontinuations related to study drug - NDA submission planned in the first half of 2026 to support full approval - BridgeBio plans to initiate registrational studies of encaleret in chronic hypoparathyroidism and pediatric ADH1 in 2026 PALO ALTO, CA – October 29, 2025 – BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced positive topline results from CALIBRATE, its global Phase 3 study of encaleret in autosomal dominant hypocalcemia type 1 (ADH1). BridgeBio will host an investor call on October 29, 2025 at 8:00 am ET to discuss these results. CALIBRATE was designed to study

SEC 8-K