Vyome Files for VT-1953 Orphan Drug Status, Furthers Strategic Focus On VT-1953 Program Over the Next 6 Months
Vyome Holdings, Inc. (HIND)
Company Research
Source: Business Wire
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 valuation of approximately $455M today and ~$1B after a successful Phase 3 studyFDA interactions planned in Q2 2026 for the Phase 3 protocol based on earlier announced positive Phase 2 results CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vyome Holdings, Inc. (“Vyome”) (NASDAQ: HIND), a clinical-stage biopharmaceutical company focused on developing therapies for serious immuno-inflammatory and rare conditions, today announced that it has filed for Orphan Drug Status for VT-1953, its lead clinical program.Key anticipated benefits of an orphan drug designation include 7 years of U.S. market exclusivity, up to 25% of tax credits on clinical trials conducted in the USA, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, which can save millions in submission costs, and speciali
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HIND
News
- Vyome Successfully Capitalizes All VT-1953 Funding Requirements For Initial Phase 3 ResultsBusiness Wire
- Independent Analyst Values Vyome’s VT-1953 at USD 1 Billion Upon Successful Completion of Phase 3 StudyBusiness Wire
- Vyome (NASDAQ:HIND) had its "sell (e-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- We're Not Very Worried About Vyome Holdings' (NASDAQ:HIND) Cash Burn Rate [Yahoo! Finance]Yahoo! Finance
- Vyome (NASDAQ:HIND) had its "sell (e-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
HIND
Sec Filings
- 1/28/26 - Form 8-K
- 12/23/25 - Form 8-K
- 11/26/25 - Form 424B3
- HIND's page on the SEC website