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PYC Therapeutics Gains FDA Orphan Drug Status
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PYC Therapeutics Gains FDA Orphan Drug Status

PYC Therapeutics Limited (AU:PYC) has released an update.

PYC Therapeutics, a clinical-stage biotech company, has received Orphan Drug Designation from the FDA for its drug candidate, PYC-001, targeted at treating Autosomal Dominant Optic Atrophy (ADOA), a rare, progressive blinding eye disease. This designation will aid the drug’s progression through clinical trials, offering benefits like tax credits, fee exemptions, and potential market exclusivity for seven years post-approval. The company is preparing to commence a phase 1 clinical trial for PYC-001 later in 2024.

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