Accessibility StatementSkip Navigation Key features of the agreement include: WASHINGTON, Oct. 1, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has agreed on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes regarding HETLIOZ (tasimelteon) and tradipitant. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innov ...

Financial Data and Key Metrics Changes - For the full year 2025, the company projects total revenues between $210 million and $250 million, with a midpoint of $230 million [23] - In the second quarter of 2025, the company reported revenue of $52.6 million, with net product sales from Fanapt at $29.3 million, Hetlioz at $16.2 million, and Ponvory at $7.1 million [23] - For the six months ended June 30, 2025, total revenue was approximately $103 million, with Fanapt being the lead revenue generator at approximately $53 million [23] - Operating expenses for the same period were approximately $182 million, resulting in a net loss of approximately $57 million [23] - The company ended the second quarter with approximately $325 million in cash and no debt [4][24] Business Line Data and Key Metrics Changes - Fanapt has seen significant prescription growth, reaching approximately 2,300 TRXs per week in mid-August 2025, compared to 1,300 to 1,400 TRXs per week around the same time last year [5] - New-to-brand prescriptions for Fanapt increased to about 240 NBRXs per week recently, up from about 40 NBRXs per week at the same time last year [5] - Hetlioz continues to face revenue erosion due to generic competition but maintains the majority of its patient population [6][7] - Ponvory, acquired from Johnson & Johnson, has shown higher patient demand in the second quarter of 2025 compared to the first quarter post-acquisition [9] Market Data and Key Metrics Changes - The company is focused on expanding its commercial footprint in the U.S. for Fanapt, increasing its sales representatives from approximately 150 to about 300 [4] - The company is pursuing FDA approval for Bysanti, with a PDUFA date set for February 21, 2026, and is also working on a clinical program for major depressive disorder [5][11] Company Strategy and Development Direction - The company aims to increase revenue both organically through existing products and through business development opportunities, as evidenced by the acquisition of Ponvory and in-licensing of imsidolumab [9][10] - The strategic focus includes advancing the pipeline with upcoming regulatory milestones that could increase the number of commercialized products from three to potentially six by the end of next year [10] - The company is committed to enhancing patient access and affordability for its medications while engaging directly with consumers [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming regulatory milestones and the potential for increased commercial presence [10] - The company remains focused on retaining market share for Hetlioz despite generic competition and is pursuing additional indications for the product [11] - Management highlighted the significant unmet medical need for gastroparesis and the potential market opportunity for tradipitant if approved [17] Other Important Information - The company has a robust pipeline with several products at various stages of development, including tradipitant for gastroparesis and motion sickness, with PDUFA dates approaching [12][16] - The company is also pursuing additional treatments for Ponvory in ulcerative colitis and psoriasis [12] Q&A Session Summary Question: What is the expected revenue for 2025? - The company projects total revenues between $210 million and $250 million for 2025, with a midpoint of $230 million [23] Question: How is the commercial launch of Ponvory progressing? - The company noted that patient demand for Ponvory in the second quarter was higher than in the first quarter post-acquisition, indicating positive momentum [9] Question: What are the plans for Hetlioz in light of generic competition? - Management stated that they are focused on retaining market share and pursuing additional indications for Hetlioz, particularly in the Smith-Magenis syndrome market [11]

Core Viewpoint - Vanda Pharmaceuticals Inc. is facing delays from the FDA regarding the hearing on the approvability of tradipitant for gastroparesis, with the FDA attributing the delay to recent staff reductions, which Vanda disputes as a valid excuse [1][2][3]. Group 1: FDA Delays and Accountability - The FDA has indicated that a reduction in force on April 1 is partially responsible for delaying the recommendation on Vanda's hearing request by at least six months [2]. - Commissioner Dr. Martin Makary has stated that the cuts did not affect scientists or reviewers, raising questions about the validity of the FDA's claims regarding the delay [2][3]. - Vanda argues that the FDA has a history of denying hearing requests for new drug approvability over the past decade, suggesting systemic issues within the agency [3][4]. Group 2: Calls for Change - Vanda urges Commissioner Makary to intervene and restore legal adherence at the FDA, asserting that the culture of delay is not due to targeted reductions in force [5]. - The company emphasizes the need for "radical transparency and common sense" in the FDA's operations, as stated by both Commissioner Makary and Secretary Kennedy [5]. - Vanda's leadership calls for the FDA and DOJ to stop obstructing innovation and to focus on improving decision-making processes [6]. Group 3: Company Overview - Vanda Pharmaceuticals Inc. is a global biopharmaceutical company dedicated to developing innovative therapies to meet significant medical needs and enhance patient lives [7].