CELC Stock Jumps After Hours On Positive Breast Cancer Trial Data

• The open-label study evaluated Celcuity’s investigational gedatolisib in combination with fulvestrant, both with and without palbociclib.
• Celcuity plans to submit the results to the FDA as part of a supplemental New Drug Application and to other regulators thereafter.
• Celcuity has submitted an application already for gedatolisib in patients with some types of breast cancer, on which the agency will decide on July 17. 

Shares of Celcuity Inc. (CELC) jumped 14% after hours after the company said on Friday that its experimental cancer drug delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with certain advanced breast cancers.

The open-label study evaluated Celcuity’s investigational gedatolisib in combination with fulvestrant, both with and without palbociclib. Patients had progressed after prior treatment with a palbociclib plus an aromatase inhibitor.

Both the gedatolisib triplet and doublet regimens outperformed the control arm, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival.

Both gedatolisib regimens were generally well tolerated with manageable safety profiles, the company said. Detailed data will be presented on June 2 at the ASCO Annual Meeting in Chicago.

“These positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with PIK3CA-mutant HR+/HER2- advanced breast cancer,” said Igor Gorbatchevsky, Celcuity’s chief medical officer.

Celcuity plans to submit the results to the FDA as part of a supplemental New Drug Application and to other regulators thereafter.

Celcuity has submitted an application already for gedatolisib in patients with some types of breast cancer, on which the agency will decide on July 17. The agency also granted priority review to the drug in the indication.

How Did CELC Retail Traders React?

On Stocktwits, retail sentiment stayed within the ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

A Stocktwits user applauded the trial data.

CELC stock has rallied over 1000% over the past 12 months. 

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