FDA Asked to Withdraw Approval of Harmony Biosciences’ Narcolepsy Drug; Review Pending 

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Wakix, a drug by Harmony Biosciences.
Image via Harmony Biosciences.
Wakix is approved to treat narcolepsy.

Scorpion Capital filed a citizens petition with the U.S. Food and Drug Administration asking to have the federal agency reverse its approval of Plymouth Meeting-based Harmony Biosciences’ narcolepsy drug Wakix, writes John George for the Philadelphia Business Journal

The New York-based short seller issued a report in March questioning the treatment’s effectiveness and the validity of the clinical trials the Montgomery County company had conducted to secure approval for the drug. 

Scorpion said it found histamine receptor antagonists like Wakix ingredient pitolisant have a “uniquely risky molecular structure with a long history of cardiotoxicity and FDA recalls.” 

Representatives of Harmony said that they did not agree with Scorpion’s assertions, which sent its shares tumbling more than 20 percent. 

“We remain committed to helping those who live with devastating rare diseases, and our science has been subject to peer review and received global regulatory approval,” said the company. 

“The Citizen Petition was filed by a short seller that is attempting to profit from driving down our stock price and deny patients’ access to an innovative and proven therapy.” 

Read more about Harmony Biosciences in the Philadelphia Business Journal

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Harmony Biosciences’ study of pitolisant.

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