Press Releases
Official announcements and milestones from Hypopara Life's advocacy journey.
BridgeBio Pharma: NDA Submitted to FDA for Encaleret for Individuals Living with ADH1
BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for encaleret for the treatment of autosomal dominant hypocalcemia type 1 (ADH1). The NDA is supported by Phase 3 CALIBRATE trial results presented at ECE 2026: 76% of participants administered encaleret achieved both serum and urine calcium within target ranges at Week 24, compared to just 4% on conventional therapy (p<0.0001). All pre-specified primary and key secondary efficacy endpoints were met. Encaleret may be eligible for priority review. BridgeBio also plans to submit a Marketing Authorization Application (MAA) to the EMA in H2 2026 and anticipates a U.S. launch in early 2027. BridgeBio also plans to initiate the RECLAIM-HP Phase 3 study of encaleret in chronic hypoparathyroidism in Summer 2026.
Read Full Release →AstraZeneca/Alexion: CALYPSO Phase III — Eneboparatide Normalises Serum Calcium and Achieves Supplement Independence in 31.1% of Adults with Hypoparathyroidism
Late-breaking results from the CALYPSO Phase III trial, presented at ECE 2026 in Prague, showed that eneboparatide (AZP-3601) met its composite primary endpoint. 31.1% of patients treated with eneboparatide achieved normalised serum calcium and independence from active vitamin D and oral calcium supplements at week 24, compared with 5.9% in the placebo group (p=0.0001). All key secondary endpoints were also met, including normalisation of urinary calcium excretion in 56.6% of patients with hypercalciuria at baseline. Eneboparatide was well tolerated over 52 weeks of treatment. Immunogenicity was observed in the majority of patients, resulting in reduced treatment effects in some patients.
Read Full Release →Septerna: SEP-479 Phase 1 Clinical Trial Initiated for Hypoparathyroidism; Strong Cash Position to Fund Operations into 2029
Septerna announced that in April 2026, it initiated a Phase 1 clinical trial of SEP-479, its potent, selective oral small molecule PTH1R agonist for the treatment of hypoparathyroidism. The single-ascending dose and multiple-ascending dose study is evaluating safety, tolerability, pharmacokinetics and pharmacodynamics (including serum calcium and endogenous serum PTH) in healthy volunteers, with data expected in late 2026 or early 2027. SEP-479 represents a novel oral small molecule approach to treating hypoparathyroidism, distinct from the peptide-based therapies currently in development. Septerna also reported a strong cash position of $522.1 million as of March 31, 2026, expected to fund operations at least into 2029.
Read Full Release →Entera Bio: EB613 Single Tablet Advanced as Phase 3 Candidate; EB612 Proof-of-Concept Data Submitted to ENDO2026
Entera Bio announced Q1 2026 financial results and key pipeline milestones for its oral peptide programs. In January 2026, Entera completed a Phase 1 PK and safety bridging study comparing the single-tablet formulation of EB613 to the multi-tablet formulation and to Forteo® (teriparatide SC injection, Eli Lilly). Entera plans to advance the single tablet of EB613 into Phase 3 as the lead candidate. PK and TPTX proof-of-concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions have been submitted as abstracts to ENDO2026 and ASBMR. EB613 represents a potential once-daily oral PTH(1-34) treatment for hypoparathyroidism — a meaningful step toward a non-injectable option for patients.
Read Full Release →BridgeBio Pharma: Encaleret NDA Submission Planned for First Half of 2026, U.S. Launch Anticipated in Early 2027
BridgeBio Pharma provided a major pipeline update on encaleret, a calcium-sensing receptor (CaSR) antagonist in development for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism. Key highlights: BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1. The Company intends to submit an NDA to the FDA in the first half of 2026, followed by a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of the year, with a U.S. launch anticipated in early 2027. Primary results from CALIBRATE, the Phase 3 registrational clinical trial, will be presented in an oral presentation at the 2026 European Congress of Endocrinology (ECE) on May 12, 2026 at 11:50 am CEST. Diagnosis of ADH1 in the U.S. continues to accelerate, with more than 1,970 unique patients identified under the dedicated ICD-10 code (E20.810) from October 2023 through January 2026. CALIBRATE-PEDS, a registrational Phase 2/3 study of encaleret in pediatric ADH1, has dosed its first participant. The Company also plans to initiate RECLAIM-HP, a Phase 3 study of encaleret in chronic hypoparathyroidism, in summer 2026 — expanding the potential encaleret franchise beyond ADH1.
Read Full Release →MBX Biosciences: Phase 3 Trial of Once-Weekly Canvuparatide for Hypoparathyroidism Advancing Following Successful FDA End-of-Phase 2 Meeting
MBX Biosciences CEO Kent Hawryluk announced continued progress across the company's pipeline in 2026, highlighting advancement toward initiation of a Phase 3 trial of once-weekly canvuparatide following a successful End-of-Phase 2 meeting with the FDA. The company also looks forward to presenting full Phase 2 Avail™ results, including one-year open-label extension data for canvuparatide. Canvuparatide is a long-acting, once-weekly PTH therapy in development for hypoparathyroidism, enabled by MBX's Precision Endocrine Peptide (PEP™) platform. MBX reports a world-class leadership team and strong balance sheet positioned to deliver improved, long-acting and well-tolerated peptide therapies for patients.
Read Full Release →Yorvipath (palopegteriparatide) Receives FDA Approval for Hypoparathyroidism
A milestone moment for the hypoparathyroidism community as the first continuous PTH replacement therapy gains approval.
Hypopara Life Launches Comprehensive Hypoparathyroidism Resource Website
New website offers calcium calculator, symptom tracker, Bridge Battery research tool, and community resources.
Bridge Battery Research Tool Introduced for Daily Hypopara Experience Tracking
A new research tool designed to capture the real-world daily experience of living with hypoparathyroidism.
Brave Butterfly Column Debuts on Hypoparathyroidism News
Bari Vapnek begins sharing her hypoparathyroidism journey through a regular column series on Hypoparathyroidism News.
HypoPARA Association, Inc. — Board Member
Bari Vapnek served as a board member of the HypoPARA Association, Inc., contributing to patient advocacy, community outreach, and awareness initiatives for the hypoparathyroidism community.