HRMY Stock Rises On Fresh FDA Approval For Wakix Tablets In Children But Wall Street Eyes Further Rally

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The FDA has approved Harmony’s Wakix tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy.

  • Wakix was first approved by the FDA for adult narcolepsy patients in 2019 and for pediatric narcolepsy patients in 2024. 
  • Harmony has an exclusive license from France’s Bioprojet to develop, manufacture and commercialize Wakix in the United States.
  • According to data from Koyfin, eight of the 11 analysts covering the stock rate it ‘Buy’ or higher while two rate it ‘Hold’ and one rates it a ‘Strong Sell.’

Shares of Harmony Biosciences (HRMY) edged up 2% on Tuesday after the company announced that the U.S. Food and Drug Administration has approved its Wakix tablets for the treatment of cataplexy in pediatric patients aged 6 years and older with narcolepsy.

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Narcolepsy is a chronic neurological disorder, characterized by an inability to regulate sleep-wake cycles, leading to extreme daytime sleepiness, sudden sleep attacks, and potential muscle weakness, also called cataplexy.

Other Approvals For Wakix

Wakix was first approved by the FDA for adult narcolepsy patients in 2019. In 2024, the agency approved it in pediatric narcolepsy patients to treat excessive daytime sleepiness. The latest approval adds to existing ones.

“WAKIX is now the first-and-only FDA-approved treatment option for both pediatric and adult narcolepsy patients with or without cataplexy that is not scheduled as a controlled substance, an important distinction that supports its clinical utility,” said CEO Jeffrey M. Dayno.

WAKIX was designed and developed by France’s Bioprojet. However, Harmony has an exclusive license to develop, manufacture, and commercialize it in the United States.

Wall Street Take

According to data from Koyfin, eight of the 11 analysts covering the stock rate it ‘Buy’ or higher while two rate it ‘Hold’ and one rates it a ‘Strong Sell.’

The average price target on the stock is at $46.73, representing a potential upside of about 30% from the stock’s closing price on Friday.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around HRMY shares rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume remained at ‘normal’ levels.

HRMY stock has dropped nearly 6% over the past 12 months. 

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