- Shares of micro-cap company Celcuity ( NASDAQ: CELC ) added 12.7% to $10.42 after hours on Monday as the clinical stage biotech was granted a Breakthrough Therapy designation by the U.S. FDA for its breast cancer treatment gedatolisib.
- The U.S. drug regulator granted gedatolisib the designation for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor.
- The FDA's Breakthrough Therapy designation process is meant to expedite the review of drugs that are intended for the treatment of serious diseases.
- CELC's gedatolisib had previously received a FDA Fast Track designation in Jan.
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Celcuity rises after hours on FDA Breakthrough Therapy nod for its breast cancer treatment