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Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $290 million and impressive gross profit margins of 94%, disclosed in a recent SEC filing that the U.S. Food and Drug Administration (FDA) has accepted its new drug application for tradipitant, aimed at treating motion sickness. The FDA has scheduled December 30, 2025, as the target decision date under the Prescription Drug User Fee Act. According to InvestingPro data, the company maintains strong financial health with a current ratio of 4.39, indicating robust operational stability as it pursues this regulatory approval.
This development was originally shared by the company via a social media post on March 14, 2025. The post criticized the FDA’s timeline, stating that the decision would come 12 months post-submission and six months past the statutory deadline. It also expressed concerns over the FDA’s 10-month review period to evaluate tradipitant’s efficacy, despite the drug having undergone two extensive controlled studies with 681 subjects. These studies reportedly showed statistically significant results in preventing motion-induced vomiting. With annual revenue of $198.77 million and analysts forecasting profitability this year, the company appears well-positioned to navigate this regulatory process. For deeper insights into Vanda’s financial health and growth prospects, InvestingPro subscribers have access to over 30 additional key metrics and analysis tools.
According to the data from the studies, the percentage of participants who vomited during vehicle travel was significantly lower in both the 170 mg tradipitant group (14.6%, p
Vanda Pharmaceuticals has made the summary of these two large motion sickness studies available for public inspection, highlighting the efficacy of tradipitant in reducing the incidence of vomiting among participants.
The company’s communication criticized the FDA’s process, describing it as indicative of a "broken, unaccountable" system that hampers innovation and negatively impacts the American public.
The information from the SEC filing, including the company’s statements and study data, has not been "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, and is not to be considered incorporated by reference in any filing under the Securities Act of 1933, except as explicitly stated in such a filing. This report is based on a press release statement.
In other recent news, Vanda Pharmaceuticals reported its fourth-quarter 2024 earnings, exceeding expectations with an earnings per share of -$0.08, compared to the forecasted -$0.17. The company also reported a revenue of $53.2 million, surpassing the forecast of $51.23 million. Analysts at H.C. Wainwright have increased their price target for Vanda to $20, maintaining a Buy rating, following the company’s strong financial performance. Vanda’s revenue for the fourth quarter saw a 17% year-over-year increase, driven by the commercial performance of its key products. Additionally, Cantor Fitzgerald reiterated its Overweight rating and $13 price target, expressing optimism about Vanda’s long-term growth potential.
Vanda Pharmaceuticals recently announced the development of a novel antisense oligonucleotide (ASO) therapeutic, VCA-894A, targeting Charcot-Marie-Tooth disease Type 2S, which has received orphan designation from the FDA. Furthermore, the company disclosed changes to its executive compensation, including adjustments to annual bonuses and base salaries, following a review by the Compensation Committee. The committee awarded restricted stock units to top executives, aligning compensation with company performance and industry standards. Vanda has projected its 2025 revenue to range between $210 million and $250 million, indicating a potential growth trajectory.
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