25.06.2024 16:53:17

Harmony Biosciences Says FDA Rejected Petition Against Wakix For Narcolepsy Treatment

(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY), Tuesday announced that the U.S. Food and Drug Administration has rejected the Citizen Petition filed by a short seller against Wakix, a medication for the treatment of excessive daytime sleepiness in patients with narcolepsy.

The FDA rejected the short seller's letter, requesting withdrawal for all indications, immediate alert distribution to prescribers, and transitioning to a Compassionate Use Program with a REMS protocol. Rejecting the request FDA clarified that it has carefully considered the information submitted in the Petition, other data available to the Agency, and relevant published literature. "Based on our review of these materials and for the reasons stated, the Petition is denied."

The Petitioner's requests come as the FDA has approved the supplemental New Drug Application or sNDA for Wakix on June 21, 2024 for pediatric patients 6 years and over, and adults with narcoleps, the company stated.

Harmony Biosciences added that it plans to submit sNDA for Wakix in idiopathic hypersomnia in second half of 2024.

Currently, Harmony Biosciences's stock is moving up 1.78 percent, to $30.64 on the Nasdaq.

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