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WASHINGTON - Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a biopharmaceutical company with a market capitalization of $252.51 million and impressive gross profit margins of 94.31%, reported that the U.S. Food and Drug Administration (FDA) has postponed the company’s request for a hearing regarding the approval of tradipitant, a drug developed for treating gastroparesis. This delay, according to the FDA, is partly due to staffing reductions that took effect on April 1, impacting the Center for Drug Evaluation and Research’s (CDER) ability to complete its recommendation. InvestingPro analysis suggests the stock is currently undervalued, with multiple positive indicators available in their comprehensive Pro Research Report.
The FDA’s justification for the delay has been met with skepticism from Vanda. The company highlights that the recent reduction in force did not affect the scientists or reviewers, who are the personnel needed to process the hearing request. Vanda also noted that CDER has a history of requesting similar delays for other drugs, indicating that this might be part of a pattern of postponements rather than an isolated incident tied to staffing changes.
Vanda’s press release emphasized that the FDA has not granted a hearing on new drug approvals for at least a decade, suggesting a systemic issue within the agency. The company’s statement also referenced a past legal interaction where an FDA representative acknowledged noncompliance with statutory requirements during a court proceeding. Despite these regulatory challenges, InvestingPro data shows the company maintains a strong financial position with a healthy current ratio of 4.39 and more cash than debt on its balance sheet.
Vanda Pharmaceuticals is calling for intervention from the newly appointed FDA Commissioner, Dr. Martin Makary, to address what it perceives as a culture of delay within the FDA. The company is advocating for a change towards more transparent and rational decision-making processes.
Dr. Mihael Polymeropoulos, President, CEO, and Chairman of the Board at Vanda, expressed the company’s stance on the necessity of transparency and common sense in regulatory processes, stating that innovation thrives in a democratic environment rather than a bureaucratic one.
The announcement comes amid ongoing discussions about the efficiency and transparency of the FDA’s drug approval process. Vanda Pharmaceuticals is a global biopharmaceutical company dedicated to developing treatments for unmet medical needs, generating annual revenue of $198.77 million. With its earnings report due on April 30, 2025, investors can access detailed financial analysis and additional ProTips through InvestingPro’s comprehensive research platform.
This report is based on a press release statement from Vanda Pharmaceuticals Inc.
In other recent news, Vanda Pharmaceuticals has submitted a New Drug Application to the FDA for Bysanti™, targeting acute bipolar I disorder and schizophrenia, with potential market availability by 2026. Additionally, the company has initiated a Phase III clinical study of Bysanti™ for major depressive disorder, with results expected in 2026. Vanda Pharmaceuticals also announced the FDA’s acceptance of its new drug application for tradipitant, aimed at treating motion sickness, with a target decision date set for December 30, 2025. The drug has shown statistically significant results in preventing motion-induced vomiting in clinical trials. H.C. Wainwright has maintained a Buy rating and a $20 price target for Vanda Pharmaceuticals, despite past challenges faced by tradipitant with the FDA. In another development, Vanda has introduced VCA-894A, an antisense oligonucleotide therapeutic for Charcot-Marie-Tooth disease Type 2S, which has received orphan designation from the FDA. The company has also made changes to its executive compensation, adjusting annual bonuses and base salaries, and awarding restricted stock units. These developments reflect Vanda Pharmaceuticals’ ongoing efforts in drug innovation and strategic management.
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