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Which regulatory body will approve ATSN-101 first by September 30, 2025?
2
Resolution / Starting Odds
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%
Regulatory approval announcements, Atsena Therapeutics press releases
Story
AAV Gene Therapy Shows Promise for LCA1 Caused by GUCY2D Mutations
Sep 10, 2024, 07:31 AM
Recent advancements in AAV gene therapy have shown promising results for patients with Leber congenital amaurosis 1 (LCA1), a rare inherited eye disorder caused by mutations in the GUCY2D gene. AAV gene therapy has demonstrated dramatic improvements in vision for affected patients, with benefits sustained for over a year. The safety and efficacy of this therapy, specifically ATSN-101, were evaluated in a phase 1/2, multicenter, open-label, unilateral dose escalation study. Atsena Therapeutics is at the forefront of this research, highlighting the potential of gene therapy in treating inherited blindness.
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EMA only • 25%
Both FDA and EMA • 25%
Neither • 25%
European Medicines Agency (EMA) • 25%
Health Canada • 25%
Japan's PMDA • 25%
Other • 25%
FDA • 33%
EMA • 33%
Both • 34%
Only in the US • 25%
Only in the EU • 25%
In both US and EU • 25%
In US, EU, and Japan • 25%
FDA (USA) • 25%
EMA (EU) • 25%
MHRA (UK) • 25%
Other • 25%
European Medicines Agency (EMA) • 25%
Medicines and Healthcare products Regulatory Agency (MHRA) • 25%
Therapeutic Goods Administration (TGA) • 25%
Other • 25%
European Central Bank • 25%
BaFin (Germany) • 25%
US SEC • 25%
Other • 25%
BLA submission • 25%
Phase III trial initiation • 25%
Conditional approval • 25%
No progress • 25%
FDA • 25%
EMA • 25%
MHRA • 25%
Other • 25%
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%
United States • 25%
European Union • 25%
China • 25%
Other • 25%
Only FDA • 25%
FDA and EMA • 25%
FDA, EMA, and MHRA • 25%
None • 25%