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2 clusters · 2 sources · 11 days · First seen · Last updated

FDA Fast Track Designations for medical therapies

Overview

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to several experimental medical treatments targeting cancer and neurological disorders.

Initial designations included BioInvent’s BI-1808, an anti-TNFR2 antibody for ovarian cancer, and Xellsmart’s XS411, a stem cell therapy for early-onset Parkinson’s disease. Subsequently, Nuvation Bio received the designation for safusidenib, an oral drug intended to treat IDH1-mutant glioma. This follows Phase 2 study data showing a 51.9% confirmed response rate, with pivotal Phase 3 trials currently underway.

Entities

FDA · BioInvent · safusidenib · Cantor Fitzgerald · BI-1808

Timeline

  1. 22 days ago

    [HEALTH] 2 sources
    Nuvation Bio receives FDA Fast Track Designation for glioma drug

    Nuvation Bio received FDA Fast Track Designation for its brain cancer drug safusidenib following positive Phase 2 data, with analysts setting a $12 price target.

  2. about 1 month ago

    [HEALTH] 2 sources
    FDA grants Fast Track Designation to cancer and Parkinson's therapies

    The FDA has granted Fast Track Designation to BioInvent’s BI-1808 for ovarian cancer and Xellsmart’s XS411, a stem cell therapy for Parkinson’s disease.

Sources

ad-hoc-news.de · stocktitan.net