Shares of Harmony Biosciences (HRMY) are under pressure after Scorpion Capital issued an investigative report on the company and said it will be shortly filing a Citizen’s Petition with the Food and Drug Administration requesting withdrawal of approval of Wakix.

APPROVAL WITHDRAWAL REQUEST: Scorpion Capital has issued an investigative report on Harmony Biosciences, saying it was shortly filing a Citizen's Petition with the FDA requesting withdrawal of approval of Wakix. The firm believes the $175,000 per year drug has "alarming" toxicity and "a trail of covered up deaths and injuries, no efficacy, sham patents," and is being pushed via "false advertising and a vast off-label and physician kickback scheme."

Furthermore, Scorpion Capital claims Wakix is a repeat of the Seldane saga, another histamine antagonist that the FDA pulled from the market and which is the "poster child for cardiac toxicity," adding that it has obtained dozens of serious adverse event reports from the FDA via Freedom of Information Act requests filed over several months, and "they paint a devastating picture of the drug's risk to even young, otherwise healthy patients," including a recent sudden cardiac death. “We believe explosive information was concealed from the FDA that would have prevented approval in 2019 – provided to us by an individual involved with the ‘successful’ key trial, who stated it was prematurely, quietly halted due to liver toxicity,” the report reads.

Wakix has been approved by the FDA to treat excessive daytime sleepiness - EDS - or cataplexy in adults with narcolepsy.

In a statement emailed to The Fly, a spokesperson for Harmony Biosciences said the company was aware of Scorpion Capital’s report and that it disagrees with their assertions. “We are aware of this report from an activist investor and disagree with their assertions. We remain committed to helping those who live with devasting rare diseases, and our science has been subject to peer review and received global regulatory approval. We'll continue to innovate and develop safe and effective medications for those in need. With regards to a Citizen Petition, we have not seen anything filed publicly at this time.”

PRICE ACTION: In Tuesday morning trading, shares of Harmony Biosciences have dropped over 22% to $32.26.

Published March 28th, 2023 10:20; Updated March 28th, 2023 11:15 to include Harmony's statement.