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WASHINGTON - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a $267 million market cap pharmaceutical company with impressive gross profit margins of 94.4%, has requested that FDA Commissioner Martin Makary review a recent decision upholding the approval of two generic versions of its drug Hetlioz, according to a company press release issued Thursday. According to InvestingPro analysis, the company maintains a strong financial position with more cash than debt on its balance sheet.
The pharmaceutical company, which analysts expect to return to profitability this year according to InvestingPro data, is challenging a July 2025 ruling by Jacqueline Corrigan-Curay, the departing director of the FDA’s Center for Drug Evaluation and Research (CDER), who upheld the Office of Generic Drugs’ earlier decision to approve the generic versions.
Vanda originally filed citizen petitions in 2023 contesting the approvals, arguing there were significant flaws in the studies and data presented by the generic manufacturers. The company claims the FDA accepted bioequivalence studies that included only Indian male subjects for establishing use in the general U.S. population.
The company also expressed concerns about data inconsistencies in measuring drug exposure levels, noting that one generic version showed exposure levels more than double those Vanda has obtained for Hetlioz.
According to Vanda, FDA officials have indicated it could take two months for the Office of the Commissioner to decide whether to review the merits of this decision.
Hetlioz is a prescription medication developed by Vanda Pharmaceuticals. The company’s challenge comes amid its concerns about what it describes as "the FDA’s unacceptable culture of bias toward approving generic drugs regardless of whether they meet the requisite legal and evidentiary standards."
The information in this article is based on a press release statement from Vanda Pharmaceuticals. With analyst price targets ranging from $5 to $20 and current trading at $4.51, InvestingPro analysis suggests the stock is currently undervalued. Discover more insights and 8 additional ProTips for VNDA, along with a comprehensive Pro Research Report, available exclusively on InvestingPro.
In other recent news, Vanda Pharmaceuticals reported its second-quarter 2025 earnings, revealing a larger-than-expected net loss and a revenue shortfall. The company posted an earnings per share of -0.46, which was below the forecasted -0.29, marking a negative surprise of 58.62%. Revenue also fell short, coming in at $52.59 million compared to the anticipated $55.1 million. In addition to its earnings report, Vanda Pharmaceuticals secured a significant legal victory. The U.S. Court of Appeals for the D.C. Circuit overturned the FDA’s previous denial of Vanda’s supplemental New Drug Application for HETLIOZ, intended for jet lag disorder treatment. The court criticized the FDA’s handling of the company’s evidence as "cursory," while acknowledging Vanda’s expert views as "specific, reasoned, and rooted in evidence." This court decision has been described by H.C. Wainwright as a "landmark victory" for Vanda Pharmaceuticals. These developments reflect ongoing challenges and achievements for the company.
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