Celcuity

CELC

Market cap $4.87B

CELC shares surge as NDA filing and strong phase III data boost optimism around gedatolisib's potential.

Celcuity Inc. surged over 750% in 2025 on best-in-class Phase 3 data for gedatolisib in HR+/HER2- advanced breast cancer. GEDATOLISIB demonstrated superior efficacy and safety versus standards of care, with median PFS of 9.3 months in VIKTORIA-1 and favorable adverse event profile. Management projects peak revenues of $2.5–$3 billion for gedatolisib; current cash position is nearly $500 million, supporting regulatory and commercial milestones.

After a weak first half, the drug and biotech sector has recovered in the past 2-3 months with large drugmakers like Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk signing drug pricing agreements with the Trump administration. A rebound in mergers and acquisitions (M&A) has also increased investor confidence in the industry.

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MINNEAPOLIS, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updated results from the randomized, Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR (“PAM”) inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA wild-type (“WT”), advanced breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. The additional study results were presented in an oral presentation session at the 2025 San Antonio Breast Cancer Symposium (“SABCS”) today, Thursday, December 11.

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New York City-based Apis Capital Advisors added 776,000 shares in CELC during the third quarter, establishing a position valued at $38.3 million. The new stake represents 8.5% of Apis' reportable assets under management at quarter-end.

Celcuity has transitioned from a speculative biotech to a de-risked pre-commercial firm, driven by unprecedented Phase 3 VIKTORIA-1 trial results. Celcuity's gedatolisib demonstrated significant efficacy and a favorable safety profile in HR+/HER2- advanced breast cancer, supporting a strong investment thesis. With a completed NDA under the FDA's RTOR program and a $455M cash position, CELC is well-funded for commercialization and pipeline expansion.

New York City-based Apis Capital Advisors added 776,000 shares in CELC during the third quarter, establishing a position valued at $38.3 million. The new stake represents 8.5% of Apis' reportable assets under management at quarter-end.