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Reassessing Celcuity (CELC) Valuation After A 51.85% Three Month Share Price Gain
Celcuity (CELC) has been drawing attention after a period of strong recent returns, including a gain over the past 3 months, prompting investors to reassess the clinical stage biotech’s risk and reward profile. See our latest analysis for Celcuity. At a share price of $107.16, Celcuity’s recent 51.85% 3 month share price return sits alongside a very large 1 year total shareholder return, which suggests investors have been rapidly repricing its prospects and risk profile. If Celcuity’s move... Jan 22, 2026 - $CELC
Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-ty Jan 20, 2026 - $CELC
Wells Fargo Initiates Coverage On Celcuity Inc. (CELC)
Celcuity Inc. (NASDAQ:CELC) is among the 20 Best Performing Stocks in 2025. On December 12, 2025, TheFly reported that Wells Fargo started covering Celcuity Inc. (NASDAQ:CELC) with a $126 price target and an Overweight rating. According to the firm, Phase 1 data and results from the wild-type cohort have significantly reduced the risk associated with […] Jan 11, 2026 - $CELC
Celcuity (CELC) Surges 662% in 2025 on Breast Cancer Treatment Trial Results
We recently published 10 Market Stars Behind Millionaire-Making in 2025. Celcuity Inc. (NASDAQ:CELC) is one of the top performers. Celcuity climbed by 661.96 percent in 2025, with the overall rally primarily fueled by strong results from the phase 3 clinical trial of its treatment candidate for breast cancer. In an updated report which was presented […] Jan 2, 2026 - $CELC
How Investors Are Reacting To Celcuity (CELC) Gedatolisib’s Phase 3 Breast Cancer Data And Safety Profile
In December 2025, Celcuity Inc. reported updated Phase 3 VIKTORIA-1 trial results at the San Antonio Breast Cancer Symposium, showing gedatolisib-based regimens improved progression-free survival and quality-of-life measures versus fulvestrant alone in certain patients with advanced HR+/HER2- breast cancer. An interesting aspect for investors is that gedatolisib appeared to avoid clinically relevant hyperglycemia, a frequent issue with some PI3K-pathway drugs, while maintaining efficacy in... Dec 17, 2025 - $CELC
Celcuity (CELC): Fresh Phase 3 Breast Cancer Data Prompts Closer Look at Gedatolisib-Driven Valuation
Celcuity (CELC) just put fresh Phase 3 VIKTORIA-1 data for gedatolisib in front of oncologists at the San Antonio Breast Cancer Symposium, sharpening the picture around efficacy, safety, and real world quality of life. See our latest analysis for Celcuity. The latest VIKTORIA-1 update lands after an explosive run, with Celcuity’s 90 day share price return of around 84% and 1 year total shareholder return close to 700%, signaling strong, momentum driven optimism around gedatolisib’s... Dec 17, 2025 - $CELC
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
For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months for fulvestrantFor patients enrolled in the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 Dec 11, 2025 - $CELC
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