Celcuity Shareholders Approve New 2026 Equity Incentive Plans
Celcuity shareholders have approved a new 2026 Stock Incentive Plan, authorizing three million shares for equity awards, and an expanded employee stock purchase plan extending for ten more years. These approvals, alongside the re-election of directors and ratification of auditors, demonstrate continued support for the company's governance and long-term equity-based incentives. An analyst rating shows a Buy with a $185.00 price target, while TipRanks' AI Analyst, Spark, rates CELC as "Neutral" due to weak financial performance often offset by technical uptrend signals and positive Phase 3 data.
MAY 4·Yahoo▲
Celcuity reports Phase III VIKTORIA-1 trial results for breast cancer
Celcuity announced positive topline results from the PIK3CA mutant cohort of its Phase III VIKTORIA-1 trial for breast cancer, showing a statistically significant improvement in progression-free survival with gedatolisib combinations. The gedatolisib triplet (gedatolisib, fulvestrant, palbociclib) and doublet (gedatolisib, fulvestrant) demonstrated superior efficacy and a manageable safety profile compared to alpelisib and fulvestrant. The company plans to submit these data to the FDA for a new drug application, highlighting the potential for gedatolisib to become a new treatment standard for HR+/HER2- advanced breast cancer regardless of PIK3CA status.
APR 27·HarianBasis.co▲
Celcuity Breast Cancer Drug Receives FDA Priority Review for 2026
The FDA has granted Priority Review for Celcuity Inc.'s lead breast cancer drug candidate, gedatolisib, with a PDUFA goal date of July 2026. Clinical data for gedatolisib, used in a triplet therapy for HR+/HER2- advanced breast cancer, showed a significant reduction in the risk of disease progression or death by 76% and a median progression-free survival of 9.3 months compared to 2.0 months for standard treatment. The biopharmaceutical firm is now preparing for commercial operations, expanding staff and securing additional financing.
