Regulatory advisors appointed for BZDS1901
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| Stock | Adalta Ltd (1AD.ASX) |
|---|---|
| Release Time | 25 May 2026, 8:17 a.m. |
| Price Sensitive | Yes |
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Adalta Appoints Regulatory Advisors for BZDS1901 CAR-T Therapy
Key Points
- AdAlta has engaged Dark Horse Consulting Group, Inc to support regulatory engagement with the FDA for BZDS1901
- Initial focus on preparing for a pre-IND meeting with the FDA
- BZDS1901 has shown promising results in patients with advanced mesothelioma
Full Summary
Adalta Limited (ASX:1AD) has engaged Dark Horse Consulting Group, Inc., a specialist in cell and gene therapy, to support its regulatory engagement with the US Food and Drug Administration (FDA) for BZDS1901, its CAR-T therapy targeting mesothelioma. The engagement aims to ensure that the manufacturing process, preclinical studies, and Phase 1 clinical trial design are aligned with FDA expectations. This early engagement is expected to enhance the efficiency and quality of the clinical trial preparation and potentially provide access to expedited regulatory pathways. BZDS1901 has shown promising results in patients with advanced mesothelioma, including complete tumor clearance in two patients.
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