MINNEAPOLIS, May 4, 2026, 14:04 CDT
Celcuity Inc. shares surged close to 16% Monday, after the Minneapolis-based biotech announced late Friday its lead drug candidate, gedatolisib, hit the primary endpoint in a late-stage breast cancer trial for patients with PIK3CA-mutant tumors. That news brought back attention to a July FDA decision and a planned cancer conference update in June for CELC stock.
The immediate question: can this new data help expand the drug’s label? Back in January, Celcuity announced the FDA had accepted its New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, put it on priority review, and penciled in July 17 as the target action date. HR+/HER2- refers to tumors fueled by hormone receptors that don’t express the HER2 protein; wild-type here means the PIK3CA gene hasn’t mutated.
Friday’s numbers target the flip side of that genetic divide. Celcuity reports PIK3CA mutations show up in roughly 40% of HR+/HER2- breast cancer cases. The company now plans to take the new data to the FDA through a supplemental application—a step toward getting the drug cleared for an additional use.
Celcuity shares changed hands at $145.54 Monday afternoon, up $19.89 on the day, with the stock earlier spiking to an intraday peak of $165. That move put the company’s market cap near $6.9 billion.
The Phase 3 VIKTORIA-1 trial looked at gedatolisib combined with fulvestrant, adding palbociclib for some patients. All participants had seen their cancer advance after treatment with a CDK4/6 inhibitor—a class designed to curb cancer-cell division—and an aromatase inhibitor, which blocks hormones. The main metric: progression-free survival, tracking how long patients went before their disease got worse or they died.
Celcuity reported its three-drug regimen outperformed alpelisib—marketed by Novartis as Piqray—paired with fulvestrant. On a secondary endpoint, the two-drug gedatolisib combo also surpassed alpelisib plus fulvestrant. According to the filing, both gedatolisib arms were generally well tolerated, with no unexpected safety issues flagged.
Sara Hurvitz, who serves as both a Fred Hutch Cancer Center and University of Washington oncologist and co-principal investigator on the trial, noted that patients in this group typically see only “modest benefit” from therapies that just target PI3K-alpha or AKT. On Celcuity’s side, Chief Medical Officer Igor Gorbatchevsky pointed to the mutant-cohort data—along with prior wild-type findings—as evidence that gedatolisib could “improve the standard of care” for patients regardless of their PIK3CA status. GlobeNewswire
Gedatolisib targets the PI3K/AKT/mTOR pathway—a key survival route for cancer cells during treatment. Celcuity steps into crowded breast cancer territory, challenging drugs already on the market that hit similar molecular drivers, like Novartis’ Piqray, Roche’s Itovebi, and AstraZeneca’s Truqap.
The spotlight stayed on the two-drug data and the ASCO slot. Jefferies’ Maury Raycroft called the doublet outcome “particularly notable.” Over at Leerink Partners, Andrew Berens commented that landing a late-breaking ASCO presentation “bodes well for the magnitude of benefit,” according to BioPharma Dive. BioPharma Dive
Stifel’s Stephen Willey bumped his Celcuity target up to $150 from $125, calling the ASCO addition the “real surprise.” Brad Canino at Guggenheim moved his target to $165 from $135, while Craig-Hallum’s Chase Knickerbocker took his up to $189 from $141, as per The Fly stories picked up by TipRanks. TipRanks
Still, these results are only top-line. Celcuity hasn’t put out the median progression-free survival numbers yet. The company flagged in its 8-K that the data come from an ongoing analysis and could shift with a deeper review. FDA review timing, possible approval, market adoption, and competition are all unresolved risks as well.
Celcuity is still parked in the clinical-stage lane. The company’s annual report shows no commercial drugs, zero revenue, and a net loss of $177.0 million in 2025. Yet, it wrapped up the year holding $165.7 million in cash and cash equivalents, plus $275.8 million in short-term investments.
Circle June 2 on the calendar: Celcuity is set to roll out its detailed VIKTORIA-1 mutant-cohort results in a late-breaking oral presentation at the American Society of Clinical Oncology meeting in Chicago. Then comes July 17, when the FDA’s target action date will decide if gedatolisib’s first filing goes beyond the data and lands a commercial launch.
