UK and Austria-based biotech F2G has won Breakthrough Therapy designation from the American regulator for its lead first-in-class candidate, olorofim.
The company, which is working on novel therapies for life-threatening systemic fungal infections, picked up the designation for treatment of invasive mold infections for certain patients with limited or no treatment options.
Olorofim, which was formerly dubbed F901318, is the first antifungal agent to be granted this designation from the US Food and Drug Administration.
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