Harmony Biosciences Holdings, Inc. (HRMY)

Harmony Biosciences sells WAKIX, a daily pill for narcolepsy, a sleep disorder that causes extreme daytime sleepiness 1.

Net product revenue rose by $60.8 million, or 30.3 percent, in the three months ended 30 June 2026 2.

The company said unit shipments grew 26.5 percent and a 7 percent price increase added to that, partly offset by higher rebates of about 4.0 percent 2.

On 12 October 2026 the company announced that chief executive Jeffrey Dayno will be retiring effective 31 December 2026 3.

Chief operating officer Peter Anastasiou has been appointed to succeed him as chief executive from 1 January 2027 3.

The FDA's review of a new pitolisant tablet, Pitolisant GR, has a target decision date of 1 April 2027 2.

Harmony acquired the exclusive right to sell the compound pitolisant in the United States from its owner, Bioprojet, in July 2017 1.

The FDA approved WAKIX in August 2019 for excessive daytime sleepiness in adults with narcolepsy, and sales began in November 2019 1.

A second approval in October 2020 added cataplexy, a sudden loss of muscle control, in adults 1.

In October 2023 Harmony bought Zynerba Pharmaceuticals, which brought a skin gel called ZYN002 1.

In April 2024 it bought Epygenix Therapeutics, which brought EPX-100, a drug in testing for Dravet syndrome and Lennox-Gastaut syndrome, two rare epilepsies 1.

In February 2025 the company received a refusal-to-file letter on its application to extend WAKIX to idiopathic hypersomnia, a rare sleepiness disorder 1.

In September 2025 a Phase 3 trial of ZYN002 in Fragile X syndrome missed its main goal, mainly because patients on placebo improved more than expected 1.

The company is phasing that program out 1.

Meanwhile WAKIX sales kept growing: net product revenue rose 21.5 percent in 2025, to $868.5 million 1.

The company said this came from an 18.3 percent rise in units shipped and a 7.0 percent price increase, partly offset by higher rebates of about 3.6 percent 1.

WAKIX

WAKIX is a once-daily tablet taken in the morning that works on histamine signaling in the brain 1.

It is the only FDA-approved narcolepsy treatment that is not scheduled as a controlled substance by the DEA 1.

In February 2026 the FDA approved WAKIX for cataplexy in children six and older, adding to its earlier approval for sleepiness in that age group 1.

The company said an average of about 8,950 patients were on WAKIX in the three months ended 30 June 2026 2.

Cost of product sold, mostly royalties, rose to 24.2 percent of revenue in the second quarter of 2026 from 19.0 percent, driven by new royalties tied to the Novitium license 2.

Pipeline

Pitolisant GR is a coated version meant to ease stomach side effects and let patients start at the full dose without a slow build-up 2.

Pitolisant HD, a higher-dose version, is in two Phase 3 trials, ONSTRIDE1 in narcolepsy and ONSTRIDE2 in idiopathic hypersomnia 2.

EPX-100 is in two Phase 3 trials, one for Dravet syndrome and one for Lennox-Gastaut syndrome 2.

BP-205, an orexin-2 receptor agonist, has an open FDA investigational application after a July 2026 submission 2.

People and places

Peter Anastasiou, the incoming chief executive, has been chief operating officer since April 2026 3.

At the end of 2025 the company had 293 full-time employees, 135 of them in commercial roles 1.

It owns no real property and leases a 35,781 square foot headquarters in Plymouth Meeting, Pennsylvania, under a lease that expires in 2031 1.

Generic rivals

Generic drug makers have filed applications to sell copies of WAKIX, and the company has settled with several of them 2.

Under its settlements, Lupin and Novugen each may sell a generic from July 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances 2.

In April 2026 the company and its licensor Novitium sued AET Pharma and Sandoz entities in federal court in Delaware over another generic application 2.

The umbrella, in words

Operations run through two wholly owned subsidiaries, Harmony Biosciences, LLC and Harmony Biosciences Management, Inc. 1.

The company owns Epygenix Therapeutics, acquired in April 2024, and Zynerba Pharmaceuticals, acquired in October 2023 1.

It agreed a license with Bioprojet for pitolisant and a research collaboration with CiRC Biosciences, a related party, on two cell therapies 1.

It also uses Chicago office space from Paragon Biosciences under a right of use agreement, where 7 employees are located 1.

The FDA has set a target decision date of 1 April 2027 for Pitolisant GR 2.

The company expects topline data from its Pitolisant HD trials in 2027 and a target decision date in 2028 2.

It expects the same timing for EPX-100: topline data in 2027 and a target decision date in 2028 2.

For Prader-Willi syndrome, a rare genetic disorder, the company anticipates topline data from its Phase 3 TEMPO study in mid-2027 2.

For BP-205, it expects multiple ascending dose data in the fourth quarter of 2026 and plans Phase 2 trials in mid-2027 2.

Anastasiou becomes chief executive on 1 January 2027 3.