Celcuity Stock Up 677% in 6 Months: What's Behind This Huge Increase?

Celcuity CELC has made significant clinical and regulatory progress in the past few months. In November, Celcuity submitted a new drug application (“NDA”) to the FDA seeking approval for its lead pipeline candidate, gedatolisib, for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. The FDA decision on the NDA is expected in 2026 and Celcuity has accelerated its commercial launch preparation.

Gedatolisib is a multi-target PAM inhibitor that comprehensively blocks the PAM pathway, differentiating it from currently approved single-target inhibitors of the PAM pathway.

The NDA was based on data from the PIK3CA wild-type cohort of the phase III VIKTORIA-1 study, which demonstrated the potential of gedatolisib as a new standard of care second-line therapy for patients with HR-positive, HER2-negative advanced breast cancer. In October, Celcuity announced positive top-line data from the PIK3CA wild-type cohort of the VIKTORIA-1 study. The data showed that the gedatolisib triplet and doublet achieved 7.3 and 5.4 months of incremental improvements in median progression-free survival, or PFS, over fulvestrant, respectively. The PFS improvements were greater than those reported by any phase III study for patients with HR+, HER2- advanced breast cancer receiving at least their second line of endocrine therapy.

There is a significant unmet need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have been previously given a CDK4/6 inhibitor. Celcuity's unprecedented efficacy results in this patient population and completion of the NDA filing led the stock to rise 677.4% in six months, outperforming the industry’s increase of 21.5%.

Enrollment is complete in the PIK3CA mutant cohort of the VIKTORIA-1 study. Top-line data from this cohort is expected in the first half of 2026. Additional studies are ongoing on gedatolisib combinations in breast cancer and prostate cancer.

Zacks Rank and Stocks to Consider

Celcuity has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Amicus Therapeutics FOLD. ANIP, CRMD and FOLD currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 adjusted EPS have increased from $7.81 to $8.08 per share. Shares of ANIP have surged 44.6% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2026 EPS have increased from $2.49 to $2.88. Shares of CRMD have surged 18.5% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, estimates for Amicus Therapeutics’ 2026 EPS have declined from 70 cents to 65 cents. Shares of FOLD have surged 52.3% over the past year.

Amicus Therapeutics’ earnings missed estimates in three of the trailing four quarters and beat in the remaining quarter, with the average negative surprise being 20.21%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research