Positive FDA panel recommendation for Vanda’s tasimelteon
The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval (by a 10 to 0 vote, with one abstention) of Vanda Pharmaceutical's (Nasdaq: VNDA) New Drug Application for tasimelteon, proposed trade name Hetlioz, for the treatment of non-24-hour disorder (Non-24) in the totally blind.
Trading in Vanda stock was halted yesterday ahead of the advisory panel meeting, but the shares nearly doubled Tuesday after an FDA staff report said the drug is effective. However, in pre-market trading this morning, the shaes rose 22% to $15.91.
The advisory panel found that:
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