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Shares of Celcuity Inc.
CELC,
were up 17% at $10.80 after hours as the U.S. Food and Drug Administration granted Breakthrough Therapy designation for a cancer drug.
The designation is for gedatolisib for certain patients with HR+/HER2- metastatic breast cancer.
Gedatolisib received Fast Track designation from the FDA in January.
Celcuity said its breakthrough application was supported by data from a Phase 1b study that assessed safety, tolerability and clinical activity in combination with palbociclib and fulvestrant.
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