Truist downgraded BioXcel Therapeutics Inc BTAI from Buy to Hold, citing significant near-term funding and clinical development headwinds.
Wednesday, the company updated recent developments with its late-stage clinical programs and patent portfolio for Igalmi (dexmedetomidine) sublingual film, including the scheduled FDA meeting to discuss the TRANQUILITY and SERENITY III programs.
The analyst writes that the cash runway is a significant risk. Truist said it would be more confident in BTAI if feedback from Oct/Nov FDA meetings indicates a favorable clinical development path for Igalmi dementia and at-home use label extensions.
While Truist maintains its optimistic outlook for Igalmi, with the current macroeconomic landscape, investors may not fully recognize its potential.
Igalmi is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.
Nevertheless, realizing substantial value remains contingent on BTAI's securing sufficient funding for expanding Igalmi into broader indications.
Price Action: BTAI shares are down 4.34% at $2.53 on the last check Thursday.
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