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Celcuity Inc. Common Stock
As of May 30, 2026 at 24:05 UTC
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About Celcuity Inc. Common Stock
Celcuity Inc is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumors. Its candidate, gedatolisib, is a kinase inhibitor of the PI3K/AKT/mTOR (PAM) pathway, binding all class I PI3K isoforms and mTORC1/2, offering comprehensive inhibition with a mechanism and pharmacokinetics differentiated from other therapies. The Phase 3 VIKTORIA-1 trial, evaluating gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2- breast cancer, has completed enrollment and reported results for PIK3CA WT tumors, with cohort 2 (PIK3CA MT) also enrolled. Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials, evaluating combinations in endocrine-resistant HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer, are ongoing.
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Latest News
5 articlesCelcuity stock rose nearly 4% after analyst Silvan Turkcan from Citizens initiated coverage with a 'market outperform' rating and $150 price target. The bullish outlook centers on gedatolisib, the company's investigational breast cancer drug, which is less than two months away from FDA review completion. The analyst highlighted the drug's potential for approval in multiple indications beyond breast cancer, which could significantly increase its value.
Celcuity stock rose over 4% after releasing its 2025 financial results, beating analyst expectations with a narrower-than-expected net loss of $0.73 per share versus the projected $1.05. The clinical-stage biotech, which has no revenue, significantly improved its cash position to $166 million from $22.5 million at end-2024, providing substantial runway. The company is also anticipating phase 3 trial results for gedatolisib in advanced breast cancer treatment in Q2.
Deerfield Management Company increased its stake in Celcuity by 980,470 shares (worth $80.6 million) in Q4, bringing its total position to $170.95 million. Celcuity's stock has surged 1,040% over the past year as the FDA accepted its new drug application for gedatolisib in breast cancer treatment with a decision date of July 17, 2026.
Celcuity announced publication of Phase 3 VIKTORIA-1 trial results showing gedatolisib combined with palbociclib and fulvestrant reduced disease progression or death risk by 76% in HR+/HER2- advanced breast cancer patients with PIK3CA wild-type mutations. The FDA has granted Priority Review for gedatolisib's New Drug Application with a decision expected by July 17, 2026.
Perceptive Advisors purchased 203,881 shares of Celcuity (CELC) in Q4 2025 for approximately $16.76 million, bringing its stake to 5.62% of AUM and making it the fund's second-largest holding. The stock has surged 700% over the past year, driven by anticipation of FDA approval for the company's lead drug candidate Gedatolisib, which has a PDUFA goal date of July 17, 2026. The significant investment by a specialist biotech investor suggests conviction that major catalysts remain ahead.