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Dow Jones Newswires: Celcuity stock soars after hours on breakthrough therapy designation for cancer drug


Shares of Celcuity Inc.

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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