Emily Bodnar, an analyst from H.C. Wainwright, has initiated a new Buy rating on vTv Therapeutics (VTVT).
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Emily Bodnar has given her Buy rating due to a combination of factors that highlight the potential of vTv Therapeutics’ lead candidate, cadisegliatin, in treating Type 1 Diabetes (T1D). The re-initiation of the Phase 3 CATT1 trial, following the FDA’s lift on the clinical hold, is a significant milestone. This trial, now with an updated protocol that shortens its duration and includes continuous glucose monitors for patients, is expected to accelerate the path towards larger pivotal studies and an eventual NDA submission.
Additionally, the promising results from the Phase 2 SimpliciT1 study, which demonstrated significant reductions in hypoglycemic episodes and HbA1c levels, have already led to the FDA granting Breakthrough Therapy Designation (BTD) for cadisegliatin. This designation underscores the drug’s potential to address unmet needs in T1D management, highlighting its efficacy and safety profile. The strategic decisions and encouraging clinical data position vTv Therapeutics favorably for future success, justifying the Buy rating.