On Thursday, Celcuity Inc. (NASDAQ:CELC) announced amendments to its Phase 3 VIKTORIA-2 clinical trial evaluating gedatolisib as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
The company also disclosed progress on a subcutaneous formulation of gedatolisib aimed at supporting long-term treatment use.
Trial To Include Endocrine-Sensitive Patients
Under the revised protocol, VIKTORIA-2 will now include a separate study evaluating patients with endocrine-sensitive HR+/HER2- advanced breast cancer in the first-line setting, in addition to the existing endocrine-resistant population.
Celcuity said it met with the U.S. Food and Drug Administration through a Type B meeting before finalizing the amended trial design.
Earlier in May, the clinical-stage biotechnology company focused on multiple solid tumors reported that its Phase 3 VIKTORIA-1 trial demonstrated a statistically significant improvement in progression-free survival (PFS) for patients treated with gedatolisib compared to standard therapies.
Igor Gorbatchevsky, chief medical officer of Celcuity, pointed to results from the company’s Phase 1b trial involving endocrine-sensitive patients treated with gedatolisib, palbociclib, and letrozole.
According to Gorbatchevsky, the study produced a median progression-free survival of 48.6 months, a median overall survival of 77.3 months, and an objective response rate of 79%.
Needham analyst on Friday wrote, “We view these initiatives as logical steps toward expanding geda’s long-term commercial opportunity.”
Analyst Gil Blum maintains the Buy rating and a price forecast of $157.
Celcuity Advances Injectable Gedatolisib Formulation
Separately, Celcuity said it filed its first patent application with the USPTO for a subcutaneous version of gedatolisib designed to be administered through injection instead of infusion.
The company said development of the formulation is ongoing as it works to establish clinical equivalence with the intravenous version. Celcuity expects the injectable formulation could support future treatment regimens involving longer therapy durations.
Needham also writes that the development of a SubQ formulation is a meaningful advancement ahead of potential expansion into the much larger frontline population.
The company’s cash, cash equivalents, and short-term investments of $387.1 million at the end of the first quarter of 2026 are expected to finance operations through 2027.
CELC Price Action: Celcuity shares were down 1.73% at $132.39 at the time of publication on Friday, according to Benzinga Pro data.
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