Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

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.

GlobeNewsWire • Dec 11, 2025

Tracking the Top-Performing Russell 2000 Stocks Against the Zacks Rank

Surprisingly, the Russell 2000 has a chance to be the second-best-performing index on the U.S. stock exchanges as we start to round out 2025, with the unprecedented push into small caps being inspired by the Fed's easing cycle.

Zacks Investment Research • Dec 12, 2025

3 Stocks You'll Wish You Bought Before 2026

Many investors have profited from the artificial intelligence (AI) trade in 2025. But there have been several up-and-coming stocks in other sectors that have posted impressive gains this year.

MarketBeat • Dec 3, 2025

Celcuity Stock Near All-Time Highs — And This Major Biotech Investor Is Still Jumping In

A top biotech fund just made a bold move while Celcuity trades near record highs—here's what they might see coming next.

The Motley Fool • Dec 2, 2025

This Fund Bought $38 Million of Celcuity as Stock Surges on Investigational Cancer Drug Results

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.

The Motley Fool • Nov 28, 2025

Celcuity: From Speculative Bet To Pre-Commercial Powerhouse

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.

Seeking Alpha • Nov 28, 2025

Celcuity To Present at Upcoming 8th Annual Evercore Healthcare Conference

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.

GlobeNewsWire • Nov 26, 2025

Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

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.

GlobeNewsWire • Nov 26, 2025

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

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.

GlobeNewsWire • Nov 17, 2025

Celcuity Inc. (CELC) Q3 2025 Earnings Call Transcript

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.

Seeking Alpha • Nov 13, 2025