Cancer Drug Stocks Surge 12% on Phase 3 Breakthrough

Celcuity Inc. (NASDAQ: CELC) closed at $139.52 on May 14 on the Nasdaq, up 12.09%. Its market capitalization rose by roughly $900 million from the prior day to about $6.7 billion (approximately KRW 9.4 trillion), with trading volume topping 1.9 million shares.

In its first-quarter financial results released that day, the company reported that its lead candidate, gedatolisib, significantly improved progression-free survival in the Phase 3 VIKTORIA-1 trial for HR⁺/HER2⁻ advanced breast cancer patients, including those with PIK3CA mutations. It also announced plans to expand the Phase 2 VIKTORIA-2 study to enroll endocrine-sensitive patients as a first-line treatment. In January, the U.S. FDA accepted the new drug application for gedatolisib in HR⁺/HER2⁻ advanced breast cancer without PIK3CA mutations under priority review, setting a PDUFA action date of July 17. The company confirmed it is preparing for a third-quarter commercial launch, further raising investor expectations.

Headquartered in Minneapolis, Minnesota, Celcuity is a clinical-stage oncology company focused on developing gedatolisib, a multi-targeted small molecule that simultaneously inhibits the PI3K/AKT/mTOR pathway in solid tumors such as breast and prostate cancer. Designed to treat a broad HR⁺/HER2⁻ advanced breast cancer population regardless of PIK3CA mutation status, gedatolisib has received both FDA Breakthrough Therapy and Fast Track designations. Upon approval, the drug could propel Celcuity into the ranks of mid-sized oncology platform companies.