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WASHINGTON - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a $258 million market cap pharmaceutical company currently trading at $4.36, secured a victory in the U.S. Court of Appeals for the D.C. Circuit against the Food and Drug Administration regarding its supplemental New Drug Application for HETLIOZ (tasimelteon) to treat jet lag disorder. According to InvestingPro analysis, the company maintains strong financial fundamentals with more cash than debt on its balance sheet.
The court set aside the FDA’s previous denial of Vanda’s application, which was originally submitted in October 2018. In its ruling, the court stated that Vanda provided expert views that were "specific, reasoned, and rooted in evidence" while the FDA’s "treatment of Vanda’s evidence is cursory." The company’s impressive 94.4% gross profit margins, as reported by InvestingPro, demonstrate its operational efficiency in drug development and commercialization.
The court noted that Vanda "clearly offered meaningful evidence of tasimelteon’s efficacy in improving sleep disturbance" and that each of its trials "showed statistically significant improvement on the primary endpoint measured."
Following the ruling, the case has been remanded back to the FDA, which must now either approve the application or grant Vanda a hearing.
The legal dispute began after Vanda submitted its application nearly seven years ago. After delays in resolving Vanda’s request for a hearing, a federal district court found that the FDA had violated requirements of the Food, Drug, and Cosmetic Act and ordered the agency to resolve the application or commence a hearing.
Instead of holding a hearing, the FDA granted itself summary judgment and refused to approve the application, prompting Vanda to file a petition for review with the appeals court.
HETLIOZ is currently approved for other uses, but Vanda has been seeking to expand its indication to include treatment of jet lag disorder.
According to the company’s press release statement, Vanda has conducted clinical studies on the drug’s effectiveness for jet lag over more than a decade, with results published in peer-reviewed journals.
The court’s decision could have implications for how the FDA evaluates scientific evidence in drug applications, requiring the agency to more thoroughly engage with evidence presented by pharmaceutical companies.
In other recent news, Vanda Pharmaceuticals reported its second-quarter 2025 earnings, showing a larger-than-expected net loss and revenue shortfall. The company announced an earnings per share (EPS) of -0.46, which was below the forecasted -0.29, resulting in a negative surprise of 58.62%. Additionally, revenues fell short of expectations, totaling $52.59 million compared to the anticipated $55.1 million. These results are part of the recent developments surrounding Vanda Pharmaceuticals. The earnings report reflects the company’s current financial challenges. Investors and analysts are closely watching these figures to assess the company’s future performance. The financial results have attracted attention from various analyst firms, although specific upgrades or downgrades were not mentioned.
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