Harmony Faces Closing Arguments on October 22 in Wakix Patent Dispute
Key Facts
The judge set October 22, 2026, for closing arguments in the Wakix litigation, according to an earnings presentation Harmony Biosciences filed with the U.S. Securities and Exchange Commission. The dispute with EET concerns the '947 and '197 patents, which the rival company challenges as either not covering its generic version or being invalid or unenforceable. Harmony said in its presentation that "the judge requested closing arguments on October 22, 2026." The proceedings follow a bench trial that began on February 17, 2026, according to the company's quarterly report. The trial ended on February 19 of the same year, with the arguments scheduled for October forming part of the post-trial proceedings. EET's legal position includes the assertion that its proposed product does not infringe the patents and/or that they are invalid or unenforceable, according to the disclosure.
Harmony said in its second-quarter earnings presentation that it had reached settlements with 6 of 7 applicants seeking approval for generic versions of Wakix. In its earnings release, the company said its intellectual property portfolio "supports Wakix exclusivity through March 2030," its stated horizon for protecting the drug. That date includes 6 months of pediatric exclusivity, according to the same release. Alongside the dispute over the two patents, Harmony filed another lawsuit against EET and Sandoz seeking to block their proposed versions until a manufacturing-process patent expires, according to Bloomberg Law. The drug's approved medical uses include treating excessive daytime sleepiness or cataplexy in patients with narcolepsy, according to its U.S. Food and Drug Administration-approved prescribing information. The label specifies that this indication covers patients aged 6 years and older.
Wakix generated net revenue of $261.3 million in the second quarter of 2026, according to Harmony's earnings release. That represented growth of 30% from the corresponding quarter a year earlier, the comparison the company reported for the drug's performance during the period. Harmony's cash, cash equivalents and investments totaled $962.5 million as of June 30, 2026, according to the earnings release filed with the Securities and Exchange Commission. The comparable balance was $882.5 million as of December 31, 2025, according to the same release. Wakix's second-quarter revenue growth was thus accompanied by an increase in cash, cash equivalents and investments at the end of June compared with the end of December, as part of the financial results reported by the company.
Wakix patent risks had previously figured in analysts' assessments of the stock, with Deutsche Bank downgrading Harmony to Hold from Buy, according to a report published by Investing.com on February 23, 2026. The bank also cut its price target to $31.00 a share from $47.00 in the report addressing patent risks. In a subsequent assessment published by the website on September 24, 2026, Oppenheimer maintained its Outperform rating. It also maintained a price target of $70.00 following Harmony's additional patent lawsuit against the generic competitor. The stock saw a separate move linked to executive leadership on October 12, 2026, when it fell 5.2% in morning trading, according to Investing.com. That decline followed the company's announcement of a planned chief executive succession, ahead of the scheduled closing arguments over Wakix.
In its leadership transition announcement, Harmony reaffirmed its 2026 Wakix net revenue guidance at a minimum of $1.0 billion. The upper end of the range reaffirmed by the company is $1.04 billion, maintaining its stated outlook for the drug's performance during the year. Harmony is scheduled to report third-quarter 2026 results on Wednesday, November 4, 2026, according to its earnings date announcement. The company said the results would be released before U.S. financial markets open that day. On drug development, it confirmed in the leadership transition announcement that it remained on track to report data from the multiple ascending dose study of BP-205 in the fourth quarter of 2026.