Ram Selvaraju, an analyst from H.C. Wainwright, reiterated the Buy rating on Bioxcel Therapeutics. The associated price target remains the same with $8.00.
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Ram Selvaraju has given his Buy rating due to a combination of factors including the recent submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA by BioXcel Therapeutics. This submission is aimed at expanding the label for IGALMI™ to include outpatient use for treating agitation associated with bipolar disorders or schizophrenia. The upcoming pre-sNDA meeting with the FDA is expected to align the company’s submission plans, reinforcing the company’s strategy to broaden IGALMI’s application.
Additionally, the imminent readout from the SERENITY At-Home pivotal trial, which is fully enrolled and focused on evaluating the safety of BXCL501 in an at-home setting, is a significant factor. The trial’s results, anticipated soon, are expected to support the label expansion. Selvaraju views the trial as low-risk, given the primary focus on safety and the existing approval of IGALMI in institutional settings. The valuation of BioXcel, based on a discounted cash flow model, supports a price target of $8 per share, considering the potential market opportunities and risks associated with the company’s pipeline.
According to TipRanks, Selvaraju is a 5-star analyst with an average return of 20.9% and a 52.81% success rate. Selvaraju covers the Healthcare sector, focusing on stocks such as Urogen Pharma, Axsome Therapeutics, and Cognition Therapeutics.