Celcuity Inc. (Celcuity (CELC)) shares are having a strong Monday morning, jumping in premarket trading after the company announced positive results from its Phase 3 VIKTORIA-1 trial. The trial, which tested the drug gedatolisib in patients with a specific type of breast cancer, hit its primary endpoint, and investors are clearly excited about what that means for the company's future.
The news is a big deal for Celcuity, a clinical-stage biotech focused on solid tumors. The VIKTORIA-1 trial showed a statistically significant improvement in progression-free survival (PFS) for patients treated with gedatolisib compared to standard therapies. The study looked at patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA mutant locally advanced or metastatic breast cancer, who had already progressed on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In other words, these are patients who have run out of good options, so any improvement is meaningful.
The company is now planning to submit these findings to the FDA as part of a supplemental New Drug Application, with a goal date of July 17, 2026. This follows the FDA's acceptance of Celcuity's New Drug Application for gedatolisib in January, which was granted Priority Review for HR+/HER2-/PIK3CA wild-type advanced breast cancer. So the regulatory wheels are turning, and this new data could broaden the drug's potential use.
There's also a secondary endpoint worth noting: the trial compared gedatolisib plus fulvestrant (the gedatolisib doublet) versus alpelisib plus fulvestrant. While this wasn't part of the primary efficacy analysis in the hierarchical order, it still showed a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. That's a nice cherry on top.
From a technical perspective, Celcuity's stock is looking strong. It's currently trading about 20.7% above its 20-day simple moving average (SMA) and 32.3% above its 100-day SMA, indicating solid short- and intermediate-term momentum. The relative strength index (RSI) sits at 57.04, which is neutral territory—meaning the stock isn't overbought or oversold, leaving room for more upside without immediate selling pressure.
Key levels to watch: resistance at $150.00, a psychological barrier that could trigger some profit-taking, and support at $120.00, where buyers might step in if the stock pulls back. The stock is currently trading near its 52-week high of $149.50, which underscores its upward trajectory. Over the past 12 months, Celcuity has delivered a staggering return of 1,058%, reflecting strong investor confidence in its pipeline.
As of Monday's premarket, shares were up 18.98% at $149.50, according to market data. The broader markets may have taken a hit on Friday, but Celcuity is clearly marching to its own beat today.
