On October 20, 2025, Needham upgraded Celcuity Inc. (NASDAQ:CELC) to a "Buy" rating, setting a new price target of $95, up from $70. At the time, CELC was trading at $74.67. Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment.
Celcuity's recent announcement of promising results from their Phase 3 VIKTORIA-1 clinical trial has likely influenced Needham's decision. The trial evaluated gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in patients with advanced breast cancer. The results, shared at the 2025 ESMO Congress, showed a significant improvement in median progression-free survival.
The gedatolisib triplet regimen reduced the risk of disease progression or death by 76% compared to fulvestrant. The doublet regimen also showed a 67% reduction in risk. These findings highlight the potential of gedatolisib in treating hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer.
Adverse events were minimal, with hyperglycemia reported in 9.2% of patients on the triplet regimen and 11.5% on the doublet. Treatment discontinuation due to adverse events was low, at 2.3% for the triplet and 3.1% for the doublet. Celcuity's management plans to discuss these findings further in a webcast and conference call.
Currently, CELC is trading at $72.33, reflecting a 39.20% increase, or $20.37, over the past year. The stock has fluctuated between $71.50 and $83 today, with a 52-week high of $83 and a low of $7.57. CELC's market capitalization stands at approximately $3.07 billion, with a trading volume of 5,265,435 shares.
