FDA Grants Orphan Drug Status to uniQure's AMT-191, Aiming to Treat Fabry Disease
Portfolio Pulse from Benzinga Newsdesk
uniQure's AMT-191, a gene therapy for Fabry disease, has received Orphan Drug Designation from the FDA. This status supports uniQure's ongoing Phase I/IIa trial and offers incentives like tax credits and market exclusivity upon approval.
September 23, 2024 | 11:07 am
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uniQure's AMT-191 has been granted Orphan Drug Designation by the FDA, which supports its Phase I/IIa trial for Fabry disease. This designation provides incentives like tax credits and market exclusivity, potentially boosting uniQure's market position.
The FDA's Orphan Drug Designation is a significant regulatory milestone that can enhance uniQure's market position by providing financial incentives and market exclusivity. This is likely to positively impact QURE's stock price in the short term.
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