Needham analyst Gil Blum reiterated a Buy rating on Celcuity today and set a price target of $29.00.
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Gil Blum has given his Buy rating due to a combination of factors, primarily driven by the positive topline results from the VIKTORIA-1 trial involving the PIK3CA wild-type cohort. The trial demonstrated significant benefits of the treatment arms, particularly geda and geda combined with palbociclib, when compared to fulvestrant alone. This outcome highlights a notable improvement in median progression-free survival over the current standard of care in HR+/HER2- metastatic breast cancer, aligning with the optimistic scenario outlined in their analysis.
Furthermore, the safety profile of geda was favorable, with lower rates of treatment-related discontinuation and hyperglycemia compared to Phase I, suggesting an advantage over other PI3K inhibitors. The promising results increase the likelihood of FDA approval and suggest that geda could significantly impact clinical practice for PIK3CA wild-type metastatic breast cancer. Additionally, these findings reduce the risk associated with the upcoming VIKTORIA-1 PIK3CA mutant readout, and the potential market size enhances the probability of a strategic acquisition, supporting the Buy rating.