Celcuity Inc. (CELC): Likely Leader in Next Generation of Breast Cancer Treatments

We just covered the Billionaire Joe Edelman’s 10 Stock Picks with Huge Upside Potential and Celcuity Inc. (NASDAQ:CELC) ranks 3rd on this list.

Celcuity Inc. (NASDAQ:CELC) stock went on a wild surge last year and hedge funds are continuing to buy the shares as they view the firm as a likely leader in the next generation of breast cancer treatments. A prominent catalyst for the company has been the stellar clinical results for gedatolisib, Celcuity’s lead candidate for HR+/HER2- advanced breast cancer. In March, results published in the Journal of Clinical Oncology confirmed that the gedatolisib triplet reduced the risk of disease progression or death by 76% compared to standard fulvestrant. The median progression-free survival (PFS) was 9.3 months for the triplet versus only 2.0 months for the control group. Funds view this 7.3-month incremental improvement as a best-in-class result that will likely disrupt the current standard of care.

There has been institutional positioning in Celcuity Inc. (NASDAQ:CELC) ahead of a major regulatory decision scheduled for this summer. In March, the firm announced that the FDA granted Priority Review for its New Drug Application for gedatolisib. The FDA has assigned a PDUFA goal date of July 2026. Institutional investors typically pile into de-risked biotech stocks three to four months before a PDUFA date, betting on a successful commercial launch. Celcuity is turning from a research lab into a commercial entity. It recently expanded its commercial headcount and added $30 million in debt financing.

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