Harmony Biosciences Holdings Inc. (HRMY:NASDA) plans to initiate a Phase Three trial in H1/22 to evaluate the safety and efficacy of Wakix (pitolisant), which promotes awakening, as a treatment for adult idiopathic hypersomnia, reported Oppenheimer analyst Francois Brisebois in a Dec. 2 research note.
"We view this label expansion opportunity as rational, considering pitolisant's efficacy and safety profile demonstrated in narcolepsy, another central disorder of hypersomnolence," Brisebois commented.
The analyst highlighted that this move by Pennsylvania-headquartered Harmony Biosciences is "derisked" and "logical" given that the symptoms of idiopathic hypersomnia, or excessive daytime sleepiness, and narcolepsy are similar.
"We are particularly encouraged that Harmony is able to jump right into Phase Three, which may turn out to be the only pivotal needed," Brisebois added.
Further, the label expansion that Harmony is pursuing, adding idiopathic hypersomnia to an existing narcolepsy indication, has already been done and U.S. Food and Drug Administration approved. Just in August, JAZZ Pharmaceuticals' expanded use of its Xywav this way. This bodes well for Harmony and Wakix.
Currently, JAZZ's Xywav is the only approved treatment for idiopathic hypersomnia. However, Brisebois purported, Wakix would complement rather than compete with Xywav because the mechanism of action of each drug differs.
Oppenheimer has an Outperform rating and a $55 per share price target on Harmony Biosciences. In comparison, the pharma's current share price is around $35.55.
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