Celcuity Reports Positive Phase 3 Results for Gedatolisib

Celcuity ( (CELC) ) just unveiled an announcement.

On May 1, 2026, Celcuity announced positive topline Phase 3 VIKTORIA-1 results in patients with PIK3CA mutant HR+/HER2- advanced or metastatic breast cancer whose disease had progressed on or after CDK4/6 inhibitor and aromatase inhibitor therapy. The gedatolisib triplet of gedatolisib, fulvestrant and palbociclib achieved a statistically significant and clinically meaningful improvement in progression-free survival compared with alpelisib plus fulvestrant, and a gedatolisib doublet regimen also outperformed the alpelisib-based control on this endpoint.

Both gedatolisib regimens showed manageable safety with no new safety signals, reinforcing Celcuity’s strategy of comprehensively blocking the PAM pathway rather than targeting a single node such as PI3Kα or AKT. The company intends to submit the VIKTORIA-1 data as part of a supplemental U.S. regulatory filing, while its separate New Drug Application for gedatolisib in PIK3CA wild-type HR+/HER2- advanced breast cancer is already under Priority Review with a mid-July 2026 decision date, positioning the drug as a potential new standard in the second-line setting regardless of PIK3CA status.

The most recent analyst rating on (CELC) stock is a Buy with a $125.00 price target. To see the full list of analyst forecasts on Celcuity stock, see the CELC Stock Forecast page.

Spark’s Take on CELC Stock

According to Spark, TipRanks’ AI Analyst, CELC is a Neutral.

Score is held back primarily by weak financial performance (pre-revenue, escalating losses/cash burn, and sharply higher leverage). This is partially offset by very strong earnings-call catalysts (Priority Review NDA and robust Phase III data) and supportive technical trend, while valuation is difficult to justify on earnings due to negative profitability and no dividend support.

To see Spark’s full report on CELC stock, click here.

More about Celcuity

Celcuity Inc. is a clinical-stage biotechnology company developing targeted therapies for solid tumors, with a lead focus on gedatolisib, a pan-PI3K and mTORC1/2 inhibitor designed to comprehensively block the PI3K/AKT/mTOR (PAM) pathway. Its primary development programs target hormone receptor positive, HER2-negative advanced breast cancer, including both PIK3CA wild-type and PIK3CA mutant subgroups.

The company’s Phase 3 VIKTORIA-1 trial evaluates gedatolisib in combination with fulvestrant, with or without the CDK4/6 inhibitor palbociclib, in patients whose disease has progressed after prior CDK4/6 therapy and an aromatase inhibitor. Celcuity is also advancing the Phase 3 VIKTORIA-2 trial, assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for endocrine-resistant HR+/HER2- advanced breast cancer.

Average Trading Volume: 723,370

Technical Sentiment Signal: Buy

Current Market Cap: $5.87B

For a thorough assessment of CELC stock, go to TipRanks’ Stock Analysis page.