Sarepta Therapeutics Announces Approval of Clinical Trial Application for SRP-1005, Its Investigational Treatment for Huntington’s Disease
Sarepta Therapeutics, Inc. (SRPT)
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Source: Business Wire
– The first-in-human clinical study of SRP-1005, known as INSIGHTT, is expected to begin in the second quarter of 2026 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has granted approval for its clinical trial application (CTA) for Study SRP-1005-101, also known as INSIGHTT. Sarepta expects to initiate this first-in-human clinical trial of SRP-1005 (formerly ARO-HTT) in the second quarter of 2026. SRP-1005 is an investigational small interfering RNA (siRNA) therapeutic for the treatment of Huntington's Disease.INSIGHTT is a Phase 1, multi-center, dose escalation study that will evaluate the safety and tolerability of subcutaneous dosing of SRP-1005 in approximately 24 participants. SRP-1005 leverages an advanced TfR1 (transferrin receptor protein 1) approach that uses monovalent fragment antigen bindi
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SRPT
Earnings
- 11/3/25 - Beat
SRPT
Sec Filings
- 1/29/26 - Form 4
- 1/29/26 - Form 4
- 1/21/26 - Form SCHEDULE
- SRPT's page on the SEC website