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biotech/news//Benzinga
Celcuity Inc. shares are up during Monday’s premarket session following positive news about its Phase 3 VIKTORIA-1 trial results.
Celcuity’s Phase 3 VIKTORIA-1 trial met its primary endpoint, improving progression-free survival in HR+/HER2- breast cancer.
KEY POINTS
The company will submit trial data to the FDA by July 17, 2026, for regulatory approval.
Gedatolisib showed statistical significance over standard therapies in PIK3CA mutant breast cancer patients post-CDK4/6 inhibitor treatment.
Celcuity shares surged almost 19% in premarket trading, nearing their 52-week high after the trial news.
Celcuity Inc. (NASDAQ:CELC) shares are up during Monday’s premarket session following positive news about its Phase 3 VIKTORIA-1 trial results.
The stock’s movement is buoyed by the announcement that the trial achieved its primary endpoint, which is expected to bolster the company’s position in the oncology market as it prepares to submit data to the FDA for further regulatory approval.
The news is contributing to the stock’s surge as investors react positively to the potential for new treatment options in breast cancer, particularly for HR+/HER2- patients, while broader markets faced declines on Friday.
Celcuity Trial Shows Progression-Free Survival Improvement
The clinical-stage biotechnology focused on multiple solid tumors on Friday reported that its Phase 3 VIKTORIA-1 trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with gedatolisib compared to standard therapies.
The trial covered patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA mutant locally advanced or metastatic breast cancer, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
The company plans to submit these findings to the FDA as part of a supplemental New Drug Application, with a goal date set for July 17, 2026.
In January, the U.S. Food and Drug Administration (FDA) accepted Celcuity’s New Drug Application and granted Priority Review for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer.
Celcuity Technical Analysis: Momentum And Key Chart Levels
CELC is currently trading well above its 20-day simple moving average (SMA) by 20.7%, indicating strong short-term momentum. The stock is also 32.3% above its 100-day SMA, suggesting a robust intermediate trend as it continues to gain traction in the market.
The relative strength index (RSI) sits at 57.04, which is considered neutral, indicating that the stock is neither overbought nor oversold at this time. This positioning suggests that there is still room for upward movement without immediate selling pressure.
Key Resistance: $150.00 — A psychological barrier that may attract profit-taking.
Key Support: $120.00 — A level where buying interest could emerge if tested.
Celcuity’s 12-month performance has been remarkable, with a return of 1058.06%, reflecting strong investor confidence and interest in its innovative therapies.
Currently, the stock is trading near its 52-week high of $149.50, which underscores its upward trajectory and the potential for further gains as it approaches critical regulatory milestones.
CELC Stock Price Activity: Celcuity shares were up 18.98% at $149.50 during premarket trading on Monday, according to Benzinga Pro data.
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