Vyome Files For Orphan Drug Status For VT-1953, Its Lead Clinical Program
Benzinga Newsdesk 8 months ago
BiotechNewsHealth CareFDAGeneral
Acceptance of Orphan Drug Status would confer certain anticipated US Market Exclusivity, R&D tax benefits, and PDUFA fee waiver of approximately $3MIndependent third-party assessment estimates a current VT-1953
- Acceptance of Orphan Drug Status would confer certain anticipated US Market Exclusivity, R&D tax benefits, and PDUFA fee waiver of approximately $3M
- Independent third-party assessment estimates a current VT-1953 valuation of approximately $455M today and ~$1B after a successful Phase 3 study
- FDA interactions planned in Q2 2026 for the Phase 3 protocol based on earlier announced positive Phase 2 results