On Thursday, Stifel, a brokerage firm, maintained its Buy rating and $40.00 price target for shares of Celcuity Inc (NASDAQ: NASDAQ:CELC), a clinical-stage biotechnology company. The firm's analyst highlighted the potential market opportunity for Celcuity's gedatolisib in treating hormone receptor-positive metastatic breast cancer (HR+ mBC), particularly following the initiation of the VIKTORIA-2 trial.
The analyst at Stifel expressed confidence in the significant valuation upside for Celcuity based on the gedatolisib opportunity in second-line HR+ mBC treatment. The recent commencement of the phase 1 VIKTORIA-2 trial is seen as a strategic move that could further increase the drug's potential upon a successful readout in the second half of 2024.
The VIKTORIA-2 trial is designed to target an endocrine-resistant patient subpopulation, which could lead to a more efficient and cost-effective study. The trial is set to have approximately five times the patient eligibility compared to Roche's inavolisib, which is also being developed for HR+ mBC. Additionally, the trial will offer a choice of CDK4/6 inhibitors, including palbociclib and the newly-preferred ribociclib, with independent cohorts and analysis for PIK3CA mutation status, in line with FDA requirements.
Stifel's analyst noted the potential for high probability of success (PoS) if gedatolisib shows benefits regardless of mutation status, given that PI3K inhibition has been validated in this patient population by inavolisib. The analyst's comments underscore the importance of pivotal trials in defining market opportunities for small to mid-size oncology companies and the strategic significance of initiating such trials.
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