WASHINGTON - Vanda (NASDAQ:VNDA) Pharmaceuticals Inc. (NASDAQ: VNDA) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has not approved its New Drug Application for tradipitant, a proposed treatment for gastroparesis symptoms. This decision was communicated to Vanda through a Complete Response Letter (CRL).
Gastroparesis is a chronic condition that impedes the stomach's ability to empty normally, causing severe symptoms like nausea and vomiting. Despite the availability of two placebo-controlled studies supporting the efficacy of tradipitant, the FDA has requested additional research that Vanda contends is inconsistent with expert advice and the nature of the disorder.
The FDA's response, which arrived more than 185 days after the NDA submission, does not comply with the Food Drug and Cosmetic Act, which mandates a review within 180 days, according to Vanda. The company believes the data provided demonstrates substantial evidence of tradipitant's efficacy and a favorable benefit-risk profile for gastroparesis patients. Vanda has sought an expert advisory committee review from the FDA without success.
Patients currently benefiting from tradipitant through an expanded access program have filed a Citizen Petition urging the FDA to approve the drug. Vanda remains committed to pursuing tradipitant's approval and will continue supporting the expanded access program.
Additionally, Vanda plans to submit a separate NDA for tradipitant to prevent vomiting in motion sickness later this year.
Vanda Pharmaceuticals , a global biopharmaceutical company, emphasizes the development of innovative therapies for unmet medical needs. The company encourages patients with inquiries about the expanded access program to reach out via email.
This article is based on a press release statement from Vanda Pharmaceuticals Inc.
In other recent news, Vanda Pharmaceuticals reported key financial figures and corporate developments. The biopharmaceutical firm announced a net loss of $8.7 million for the first half of 2024, despite a 10% increase in total revenues for the second quarter compared to the previous year. The company provided revenue guidance for 2024 between $180 million and $210 million and cash guidance between $360 million and $390 million.
Vanda Pharmaceuticals also highlighted FDA approval of Fanapt for bipolar I disorder and the expansion of their commercial organization. They are developing a new drug application for milsaperidone and initiating a clinical program for major depression. Furthermore, Vanda's launch strategy for tradipitant includes delabeling and direct-to-consumer campaigns, with a sales force three times larger than at the beginning of the year.
In addition, Vanda Pharmaceuticals has announced amendments to its shareholder rights agreement, introducing precise changes to the definitions of "Acquiring Person," "Acting in Concert," and "Beneficial Owner." These changes aim to provide a clearer framework for identifying individuals or groups that may be acting together to acquire a significant interest in the company. These are the recent developments for Vanda Pharmaceuticals.
InvestingPro Insights
As Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) navigates the challenges surrounding the FDA's recent decision, investors and stakeholders may find solace in some of the company's financial metrics and analyst expectations. According to InvestingPro, Vanda holds more cash than debt on its balance sheet, which could provide flexibility in funding additional research requested by the FDA or advancing other pipeline projects.
In terms of financial health, the company's gross profit margin for the last twelve months as of Q2 2024 stands at an impressive 93.03%, reflecting a strong ability to control the cost of goods sold and manage production efficiently. This is particularly relevant as Vanda continues to invest in the development and potential market launch of tradipitant.
Another key metric for investors is the company's market capitalization, which currently stands at $288.53 million. This valuation, coupled with a significant price uptick over the last six months, indicating a 31.65% return, suggests that the market is recognizing the potential value in Vanda's pipeline and growth prospects.
For those interested in delving deeper into the company's financials and future outlook, InvestingPro offers additional tips and metrics. Currently, there are eight more InvestingPro Tips available for Vanda Pharmaceuticals, which can provide further insights into the company's profitability forecasts, cash flow considerations, and market performance expectations.
InvestingPro also provides an estimated fair value of $6.45 for Vanda's stock, which is above the previous close price of $4.95. This fair value estimate may be of interest to investors considering the stock's potential upside in light of recent developments and the company's financial position.
For comprehensive analysis and more tailored InvestingPro Tips, interested parties can explore the full suite of insights available at https://www.investing.com/pro/VNDA.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.