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  • FDA sets May 2027 decision date on AMT-130 gene therapy for HD

    FDA sets May 2027 decision date on AMT-130 gene therapy for HD

    4 min read

Latest News

HDBuzz Trial Tracker

Phase 3 trial of SOM3355 expected to begin

SOM Biotech
Expected: Q4 2026

FDA accepts BLA for Priority Review, with a target decision date of 1 May 2027.

uniQure
Expected: May 2027

Launch of pivotal clinical trial for brezosiran

Alnylam Pharmaceuticals
Expected: 2027
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Update on plans for a Phase 2/3 study of WVE-003

Wave Life Sciences
Expected: Not disclosed

PRECISE-HD Phase 3 trial of pridopidine begins recruitment

Prilenia-Ferrer
Expected: N/A

Updates from the ongoing Phase 3 INVEST-HD trial of votoplam

Novartis/PTC Therapeutics
Expected: Not disclosed

Updates from the Phase 1b/2a REGEN4HD trial of neural stem cell therapy hNSC-01

University of California, Irvine
Expected: Not disclosed

Further update from the Phase 1/2a trial of VO659

Vico Therapeutics
Expected: Not disclosed

Updates from the Phase 1/2 trial of RG6662 (SPK-10001) gene therapy

Roche
Expected: Not disclosed

Updates from the ongoing Phase 2/3 FALCON-HD trial of SKY-0515

Skyhawk Therapeutics
Expected: Not disclosed

Updates from the Phase 1 INSIGHTT trial of SRP-1005

Sarepta Therapeutics
Expected: Not disclosed

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