After Soleno Therapeutics announced a regulatory update from the Food and Drug Administration and reported that the FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application for diazoxide choline-controlled release, or DCCR, extended-release tablets for the treatment of Prader-Willi syndrome, or PWS, Stifel said the news “comes as a positive surprise.” While the implications on the overall approvability remain to-be-determined, based on the firm’s conversations and optimism arising from its own work, Stifel is maintaining its view of the “high probability of approval for DCCR” and keeps a Buy rating and $74 price target on Soleno shares, which are up $7.37, or 15%, to $55.00 in early trading.
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