Celcuity announced FDA approval of REVTORPYK (gedatolisib), the first pan-PI3K and mTORC1/2 inhibitor, for treating HR+/HER2- locally advanced or metastatic breast cancer without PIK3CA mutations. In the Phase 3 VIKTORIA-1 trial, the drug reduced disease progression or death risk by 76% when combined with palbociclib and fulvestrant, and 67% with fulvestrant alone. Commercial launch is anticipated in late Q3 2026.

Celcuity Inc., a clinical-stage biotechnology company, announced the pricing of an upsized $500 million convertible senior notes offering due 2032, increased from the previously announced $400 million. The company plans to use net proceeds of approximately $484.3 million to repay Oxford Finance debt and fund working capital, clinical trials, and R&D. The convertible notes carry a 0.250% interest rate with a conversion price of approximately $124.53 per share, representing a 40% premium to the stock price on June 3, 2026.

Celcuity 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.

Soleus Capital Management increased its stake in Celcuity by 629,398 shares, bringing its total holdings to over 1.8 million shares valued at $180.36 million. This purchase elevated Celcuity to Soleus's third-largest holding, representing 6.7% of the fund's AUM. The move signals bullish confidence in the clinical-stage biotech company, which has seen its stock surge 745% over the past year.

Celcuity director David Dalvey sold 20,000 shares indirectly for $2.4 million on January 27, 2026, representing 18.18% of his holdings. The sale occurred via a Rule 10b5-1 trading plan through Brightstone Venture Capital Fund. Despite the insider sale, Celcuity stock has surged 933% over the past year following positive clinical trial results for its breast cancer treatment, though the company remains unprofitable.

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Apis Capital Advisors invested $38.3 million in Celcuity, acquiring 776,000 shares during Q3 2025, making it their largest holding. Celcuity, a clinical-stage biotech firm, has seen its stock surge 669% in a year following positive phase 3 results for its cancer drug gedatolisib.

Celcuity announced promising Phase 3 trial results for gedatolisib, a multi-target PAM inhibitor for advanced breast cancer, demonstrating significant improvements in progression-free survival and response rates compared to standard treatment.