BridgeBio to present CALIBRATE Phase 3 encaleret data at ASBMR 2026
BridgeBio Pharma has confirmed it will present additional results from the Phase 3 CALIBRATE trial of encaleret at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting in Boston, running 9-12 October. The presentations focus on autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic form of hypoparathyroidism for which effective oral therapies remain scarce.
Two oral presentations are scheduled for Sunday 11 October. Erik A. Imel of Indiana University School of Medicine will present 24-week results covering mineral homeostasis and bone turnover, while Steven W. Ing of Ohio State University Wexner Medical Center will report participant-reported changes in symptoms and treatment experience. Both readouts extend earlier CALIBRATE datasets and will give clinicians and investors a fuller picture of encaleret's benefit-risk profile ahead of any regulatory filing.
What the data covers
The company is presenting across three distinct dimensions. The bone turnover and mineral homeostasis data address a core pharmacological question: whether encaleret's selective negative modulation of the calcium-sensing receptor (CaSR) translates into durable biochemical correction in ADH1 patients, who typically present with hypocalcaemia, hypercalciuria, and suppressed parathyroid hormone. The patient-reported outcome findings will be equally scrutinised, since regulators increasingly require robust PRO evidence to support labelling claims in rare-disease submissions.
A third strand involves family cascade genetic testing. In partnership with the HypoPARAthyroidism Association, BridgeBio will present findings from a proband-initiated model that delivers no-cost genetic testing and counselling to at-risk relatives via regional events. This population identification work has both humanitarian and commercial logic: ADH1 is frequently under-diagnosed, and expanding the identified patient pool directly affects commercial addressable market estimates for an approved product.
BridgeBio will also display a poster on infigratinib, its FGFR inhibitor in development for achondroplasia, presenting pharmacokinetic data showing an absence of peripheral FGFR1 inhibition at clinically relevant exposures. This is intended to underpin the safety case for the PROPEL paediatric programme, where growth-plate effects are a key monitoring concern.
Regulatory and competitive context
Encaleret holds FDA Fast Track Designation and Orphan Drug Designation in the United States, European Union, and Japan, which provides procedural advantages at the review stage but does not guarantee approval. Chronic hypoparathyroidism is a contested space: Shire's recombinant PTH analogue natpara (parathyroid hormone 1-84) was withdrawn from the US market in 2019 over a rubber stopper contamination issue, leaving a gap that several developers have targeted. Ascendis Pharma's palopegteriparatide has since progressed in chronic hypoparathyroidism, and BridgeBio will need to differentiate encaleret on the basis of its oral route, its ADH1-specific mechanism, and the depth of its clinical dataset.
The ASBMR presentations do not constitute a regulatory submission, but conference data packages typically inform the endpoints and evidence summaries included in an NDA or MAA. Investors will monitor whether the 24-week bone turnover signals and PRO data are consistent with the biochemical improvements reported at earlier timepoints. BridgeBio has not yet announced a filing date for encaleret, making the ASBMR readout a meaningful waypoint in the development timeline.
For a company of BridgeBio's scale, managing multiple rare-disease programmes simultaneously carries capital allocation risk. The encaleret data, alongside the infigratinib achondroplasia safety work, will help investors assess how the company is prioritising its pipeline as it balances earlier commercial revenues against ongoing Phase 3 expenditure.