Celcuity

CELC

Market cap $4.68B

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.

MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract was accepted for an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS) and is now available on the SABCS website. The 2025 SABCS is being held virtually and in-person from December 9-12, 2025. The presentation will include additional sub-group efficacy analyses and safety data.

MINNEAPOLIS, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the 8th Annual Evercore Healthcare Conference to be held in Miami, Florida on December 2-4, 2025.

MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast cancer (“ABC”). The NDA was submitted under the FDA's Real-Time Oncology Review (“RTOR”) program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.

Celcuity Inc. ( CELC ) Q3 2025 Earnings Call November 12, 2025 4:30 PM EST Company Participants Brian Sullivan - Co-Founder, Chairman & CEO Vicky Hahne - Chief Financial Officer Conference Call Participants Apoorva Chaloori Maurice Raycroft - Jefferies LLC, Research Division Tara Bancroft - TD Cowen, Research Division Bradley Canino - Guggenheim Securities, LLC, Research Division Dara Azar - Stifel, Nicolaus & Company, Incorporated, Research Division Oliver McCammon - LifeSci Capital, LLC, Research Division Jacob Soucheray - Craig-Hallum Capital Group LLC, Research Division Presentation Operator Good afternoon, ladies and gentlemen, and welcome to the Celcuity's Third Quarter 2025 Financial Results Webcast and Conference Call. [Operator Instructions] I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare.

Presented detailed efficacy and safety results from the PIK3CA wild-type (“WT”) cohort of the Phase 3 VIKTORIA-1 clinical trial at a late breaking oral presentation at the 2025 European Society for Medical Oncology (“ESMO”) Congress Presented updated clinical results from the Phase 1b portion of a clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide) in men with metastatic castration resistant prostate cancer (“mCRPC”) at a poster session at ESMO Completed enrollment of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial and expect topline data to be available sometime in late Q1 2026 or during Q2 2026 Submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (”FDA”) for gedatolisib, based on data from the PIK3CA WT cohort, is on track to be completed during the fourth quarter of 2025 Management to host webcast and conference call today, November 12, 2025, at 4:30 p.m. ET MINNEAPOLIS, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced financial results for the third quarter ended September 30, 2025 and other recent business developments.

MINNEAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the third quarter 2025 after the market closes on Wednesday, November 12, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m.

MINNEAPOLIS, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the Stifel 2025 Healthcare Conference to be held in New York on November 11-13, 2025.