[/bHetlioz -- PDUFA date 01/31/2014
If Vanda Pharmaceuticals' (NASDAQ: VNDA ) one-year stock chart were a roller-coaster ride at an amusement park, it might win first place for scariest attraction.
The company can attribute much of its recent success to Hetlioz (formerly tasimelteon), its non-24-hour drug designed to help totally blind people regulate their sleep habits. Whereas the majority of us use the sun as our natural meridian marker that tells us when to sleep (unless you're a vampire, of course), people who are blind have no marker to use and thus have unregulated sleeping habits. Hetlioz is expected to normalize those sleeping habits.
In mid-November the FDA's advisory panel voted overwhelmingly to recommend approval of Hetlioz as a non-24-hour drug (which would make it the first of its kind), finding that it met its primary endpoint in trials and adequately demonstrated that the drug was safe. While dapagliflozin appears to be the more exciting approval possibility, Hetlioz appears to be the drug with the best chance of obtaining approval in January with its Jan. 31 PDUFA decision date.
With peak sales estimates globally of $500 million, Hetlioz isn't going to turn Vanda into a superstar overnight, but it does have the potential to put Vanda back on the buyout radar.
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