CELC Stock Clocks Best Day In About 2 Months On First FDA Approval For Cancer Drug

• The FDA approved gedatolisib in combination with cancer drug fulvestrant, with or without Pfizer’s palbociclib.
• This approval gives the company its first marketed product and transitions it from a pure development-stage firm to one with a commercial opportunity.
• Celcuity’s pipeline remains centered on gedatolisib, with ongoing work in earlier lines of breast cancer and prostate cancer.

Shares of Celcuity Inc. (CELC) jumped 7% on Tuesday after the U.S. Food and Drug Administration approved its drug gedatolisib in combination with cancer drug fulvestrant, with or without Pfizer’s palbociclib.

The approval covers adults with advanced hormone receptor-positive, HER2-negative breast cancer without a PIK3CA mutation whose disease progressed after prior hormone therapy.

The stock on Tuesday clocked its best day since May.

CELC's Trial Results

The decision is based on the late-stage VIKTORIA-1 trial. The three-drug combination (gedatolisib + palbociclib + fulvestrant) cut the risk of disease progression or death by 76% and extended median progression-free survival to 9.3 months, compared with just two months on fulvestrant alone.

The two-drug combination (gedatolisib + fulvestrant) reduced risk by 67%, with a median PFS of 7.4 months. Response rates were also significantly higher with both gedatolisib regimens.

Progression-Free Survival (PFS) is the length of time during and after treatment that a patient lives with a disease, like cancer, without it getting worse. It measures how long a therapy successfully keeps the tumor from growing, spreading, or returning.

Gedatolisib is given as a weekly intravenous infusion. The company intends to launch the drug commercially in the third quarter.

Company Pipeline And Impact

Gedatolisib, in-licensed from Pfizer in 2021, is Celcuity’s sole late-stage asset and has been the focus of its entire development program.

This approval gives the company its first marketed product and transitions it from a pure development-stage firm to one with a commercial opportunity in advanced breast cancer. Celcuity’s pipeline remains centered on gedatolisib, with ongoing work in earlier lines of breast cancer and prostate cancer.

Celcuity had cash, cash equivalents, and short-term investments of $387.1 million as of the end of last quarter. Celcuity then said its current cash position, together with its debt facility, is expected to fund operations through 2027.

How Did CELC Retail Traders React?

On Stocktwits, retail sentiment around CELC stock stayed within the bullish territory over the past 24 hours, while message volume stayed at extremely high levels.

A Stocktwits user opined that the stock should have rallied further on “such a big news.”

Another user voiced hopes for a buyout of the company.

A third user termed the stock a “huge opportunity” under $115.

According to data from Koyfin, all 12 analysts covering CELC stock rate it ‘Buy’ or higher. The stock has a 12-month average price target of $160.64, representing a potential upside of about 45% from its last close.

CELC stock has gained 11% year-to-date. 

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