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BridgeBio Pharma (BBIO) investor relations material
BridgeBio Pharma Investor Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Investor Update summary10 Sep, 2025
Disease Overview and Patient Experience
ADH1 is a rare, autosomal dominant disorder caused by activating variants in the calcium-sensing receptor (CASR), leading to hypocalcemia, low or suppressed PTH, and high urinary calcium, with significant neuromuscular and renal complications.
Standard care with calcium and vitamin D supplementation often fails to correct the underlying pathophysiology and may worsen long-term renal complications.
ADH1 is frequently underdiagnosed, with a median age of genetic confirmation at 25 years and a prevalence of about 1 in 25,000.
Genetic testing is crucial for definitive diagnosis and family screening.
Patient stories highlight the burden of disease, frequent monitoring, and the hope for targeted therapies.
Unmet Need
No therapies are specifically indicated for ADH1, representing a significant unmet need.
Incalerit/Encaleret Mechanism and Clinical Development
Incalerit/Encaleret is an investigational oral calcilytic that acts as a negative allosteric modulator of the CaSR, aiming to restore PTH secretion, normalize blood calcium, and reduce urinary calcium.
Phase II/2 studies in 13 patients showed robust, sustained normalization of blood and urine calcium and PTH over 42 months, with a favorable safety profile and most adverse events being mild or moderate and transient.
Nearly 69% of patients achieved both blood and urine calcium in the normal range, a result not seen with standard care.
The ongoing Phase III CALIBRATE study is a randomized, controlled trial enrolling 71 participants aged 16 and older, with a primary endpoint of achieving target blood and urine calcium at 24 weeks; topline results are expected in Fall 2025.
Secondary endpoints include PTH, vitamin D, magnesium, phosphate, renal function, and quality of life.
What initiatives accelerate ADH1 diagnosis?
Encaleret's advantage over PTH in ADH1?
Clinically meaningful Phase III response rate?
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Next BridgeBio Pharma earnings date
Q3 20253 Nov, 2025
Next BridgeBio Pharma earnings date
Q3 20253 Nov, 2025
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Frequently asked questions
BridgeBio Pharma, Inc. engages in the discovery, development, and delivery of various medicines for genetic diseases. The company's lead candidates for the treatment of Fabry disease comprise a pipeline of recombinant enzyme-replacement therapies comprising elaprase and lysosomal-phospholipid-glycoprotein (PLG) analogs. It focuses on developing therapeutics for treating Fabry disease, a rare genetic disorder characterized by progressive loss of kidney function and the buildup of fatty substances that damage blood vessels and organs. BridgeBio Pharma, Inc.i s based in Waltham, Massachusetts.
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