BofA warns Fed risks policy mistake with early rate cuts
Investing.com - Vanda Pharmaceuticals (NASDAQ:VNDA), a pharmaceutical company with impressive gross profit margins of 94.4% and a strong balance sheet showing more cash than debt, received a boost earlier this week after securing what H.C. Wainwright called a "landmark victory" over the FDA in a dispute regarding its drug HETLIOZ for jet lag disorder treatment. According to InvestingPro data, the company appears slightly undervalued at current levels.
The U.S. Court of Appeals for the D.C. Circuit set aside the FDA’s previous refusal to approve Vanda’s supplemental New Drug Application (sNDA), which was originally submitted in October 2018. The court noted that Vanda provided expert views that were "specific, reasoned, and rooted in evidence" while criticizing the FDA’s "cursory" treatment of the company’s evidence. With revenue of $203.5 million in the last twelve months and a market capitalization of $272.4 million, this regulatory development could significantly impact the company’s growth trajectory.
In its ruling, the court acknowledged 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." This decision comes after a federal district court had previously found that the FDA "violated" requirements of the Food, Drug, and Cosmetic Act.
H.C. Wainwright maintained its Buy rating and $20.00 price target on Vanda following the news. The firm indicated that this development could eventually lead to HETLIOZ approval for jet lag disorder, though the timeline remains uncertain.
The research firm noted that potential approval in this new indication could generate additional revenue not currently factored into its forecasts, which currently only account for "progressive generic erosion of branded tasimelteon sales" in already-approved indications.
In other recent news, Vanda Pharmaceuticals reported its second-quarter 2025 earnings, revealing a deeper-than-expected net loss and revenue shortfall. The company posted an earnings per share of -0.46, missing the forecast of -0.29, which represented a negative surprise of 58.62%. Revenues also fell short, coming in at $52.59 million against the anticipated $55.1 million. In a separate development, Vanda Pharmaceuticals secured a legal victory when a federal appeals court overturned the FDA’s denial of its drug Hetlioz for treating jet lag disorder. The court found that Vanda provided expert views that were "specific, reasoned, and rooted in evidence," while criticizing the FDA’s evaluation as "cursory." This ruling effectively sets aside the FDA’s previous denial of Vanda’s application, which was originally submitted in October 2018. These recent developments reflect significant shifts in Vanda Pharmaceuticals’ ongoing business activities.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.