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Celcuity initiated with an Outperform at Leerink

Leerink initiated coverage of Celcuity with an Outperform rating and $29 price target. Celcuity is a clinical-stage biotechnology company developing gedatolisib, a next-generation inhibitor of the PI3K/AKT/mTOR currently being evaluated in HR+ HER2- patients in the Phase 3 trial VIKTORIA-1. The firm notes early data suggest geda has the potential for a best-in-class PAM pathway inhibitor in patients with PIK3CA mutations and in wild-type patients. Phase 3 VIKTORIA-1 will prospectively segment patients into a PIK3CA WT cohort and a PIK3CA MT cohort, with the WT cohort readout in the second half of 2024 and the MT cohort readout in the first half of 2025. Leerink thinks both readouts have a high likelihood of succeeding based on its review of early datasets and historical expectations for the control arms in this trial.

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