Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta
Vir Biotechnology, Inc. (VIR)
Company Research
Source: Business Wire
– Designations aim to expedite the development and review of promising therapies for serious conditions with unmet medical needs –– Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025 – SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting® in San Diego, U.S. Vir Biotechnology’s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.CHD is a chronic, progressive liver disease caused by the hepatitis delta virus
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VIR
News
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- Vir Biotechnology to Participate in the 7th Annual Evercore ISI HealthCONx Conference [Yahoo! Finance]Yahoo! Finance
VIR
Earnings
- 10/31/24 - Miss
VIR
Sec Filings
- 12/4/24 - Form 4
- 12/2/24 - Form 144
- 11/18/24 - Form 4
- VIR's page on the SEC website