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NEUTRAL

AstraZeneca's Eneboparatide Meets Primary Endpoint in Hypoparathyroidism Trial

Why we think this is neutral

This RNS announcement provides an update on the successful Phase III trial of AstraZeneca's investigational treatment for hypoparathyroidism, eneboparatide. While the results are positive, the announcement does not contain any of the mandatory news types that would require a more detailed analysis.

Key Points

  • Eneboparatide met primary endpoint of normalizing serum calcium in adults with hypoparathyroidism at 24 weeks in CALYPSO Phase III trial
  • Trial continues as planned to 52 weeks to further characterize the risk-benefit profile
  • Hypoparathyroidism is a rare endocrine disease affecting over 200,000 people in the US and EU, with approximately 80% being women

Summary

The biopharmaceutical company's investigational treatment for a rare endocrine disease met its primary endpoint in a Phase III trial, paving the way for further development.

AstraZeneca PLC announced that its investigational parathyroid hormone (PTH) receptor 1 agonist, eneboparatide (AZP-3601), met the primary endpoint in the CALYPSO Phase III trial for the treatment of chronic hypoparathyroidism (HypoPT). The trial showed that eneboparatide was able to normalize serum calcium levels and reduce the need for active vitamin D and oral calcium therapy in adults with HypoPT. The company plans to further analyze the full 52-week data and share the results with global health authorities.

Key Dates

Q4 2025
Presentation of 52-week data from CALYPSO trial
2026
Potential regulatory submission for eneboparatide
GENERAL UPDATE