Harmony Biosciences Study Misses Primary Endpoint

by Warren Seah

Shares of Harmony Biosciences Holdings have bounced back by 9% to reach $23.04 following a drop last Friday. The company recently announced that its Phase 3 study did not meet the primary endpoint for pitolisant in patients suffering from idiopathic hypersomnia.

Last Friday, the stock experienced a substantial decline of 30%, hitting a 52-month low of $18.61. Over the past year, the stock has fallen by 55%.

Analysts Adjust Price Targets

On Monday, Raymond James lowered the price target for Harmony Biosciences Holdings to $26 from $58 per share, although it maintained its outperform rating. Similarly, Needham analysts reduced their price target to $53 per share from $66, while keeping their buy rating intact.

Study Results and Additional Data Analysis

The Phase 3 study revealed no statistically significant difference between the pitolisant and placebo groups in terms of excessive daytime sleepiness. However, positive trends favoring pitolisant were observed in various secondary endpoints. Further analysis of the data is currently underway.

Notably, approximately 88% of patients involved in the study voluntarily proceeded into a 12-month long-term extension study, which is still ongoing.

Safety and Tolerability Profile

The safety and tolerability profile of pitolisant in adult patients with idiopathic hypersomnia was consistent with the established safety profile. No new safety signals were observed during the study.

Pitolisant as Wakix for Excessive Daytime Sleepiness

Pitolisant is marketed as Wakix in the U.S., indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.

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