# FDA Fast Track Designations for medical therapies

> Live situation record from CLSTR: https://clstr.news/situations/fda-fast-track-designations-for-medical-therapies
> Updated: 2026-08-20T12:00:00.000Z. Sources: 2. Developments: 2.

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.

## Timeline

### 2026-08-20: 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 sources. https://clstr.news/cluster/nuvation-bio-receives-fda-fast-track-designation-for-glioma-drug

### 2026-08-10: 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.

2 sources. https://clstr.news/cluster/fda-grants-fast-track-designation-to-cancer-and-parkinsons-therapies

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Cite as: FDA Fast Track Designations for medical therapies. CLSTR, https://clstr.news/situations/fda-fast-track-designations-for-medical-therapies