Soligenix submits NDA to FDA for HyBryte in cutaneous T-cell lymphoma; targets H2 2023 approval

SOLIGENIX, INC.

NDA submitted for HyBryte (synthetic hypericin) to treat early stage CTCL, a rare cancer affecting >25,000 US patients.
NDA has FDA orphan drug and fast track designations; company anticipates potential approval in H2 2023.
Company estimates worldwide market for HyBryte in CTCL at over $250 million.
US launch targeted for Q1 2024, contingent upon FDA approval.

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