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On Wednesday, H.C. Wainwright reaffirmed its Buy rating and $20.00 price target for Vanda Pharmaceuticals (NASDAQ:VNDA), currently valued at $296 million, following recent developments with the company’s new drug application. According to InvestingPro data, the company maintains impressive gross profit margins of 94.3% and holds more cash than debt on its balance sheet. Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application for tradipitant, aimed at treating motion sickness. The FDA has set a target decision date of December 30, 2025, under the Prescription Drug User Fee Act (PDUFA).
The PDUFA date is scheduled for 12 months following the submission of the application and six months past the statutory deadline. Additionally, the FDA indicated it would require a 10-month review period to evaluate the clinical study outcomes to determine tradipitant’s efficacy. Tradipitant has undergone testing in two extensive, controlled studies involving 681 subjects, with results demonstrating statistically significant prevention of motion-induced vomiting.
Despite the acceptance of the NDA and the assignment of a PDUFA date, which H.C. Wainwright views as a slight positive, the firm remains cautious. This caution stems from past difficulties tradipitant faced with the FDA, including a denied NDA for the drug’s use in treating gastroparesis. A hearing on this matter is expected in the upcoming months. InvestingPro analysis shows the company’s overall financial health score is "GOOD," with particularly strong metrics in price momentum and cash flow management. Get access to 6 more exclusive ProTips and comprehensive analysis through InvestingPro’s detailed research reports.
H.C. Wainwright’s position does not currently account for any potential revenue from tradipitant for motion sickness or gastroparesis in its valuation assessment. The firm suggests that this conservative approach may be revised pending future outcomes. The reiterated Buy rating and 12-month price target of $20 emphasizes the firm’s continued confidence in Vanda Pharmaceuticals’ overall prospects. Based on InvestingPro’s Fair Value analysis, the stock currently appears undervalued, with analyst targets ranging from $5 to $20.
In other recent news, Vanda Pharmaceuticals reported a fourth-quarter 2024 revenue of $52.3 million, exceeding the forecast of $49 million, and a full-year net loss of $0.33 per share, narrower than the anticipated $0.38 per share loss. H.C. Wainwright responded by raising its price target for Vanda to $20, maintaining a Buy rating. The firm also adjusted its 2025 revenue forecast to $225 million, down from $235 million, citing a $15 million payment obligation to a licensor. Meanwhile, Cantor Fitzgerald reiterated an Overweight rating with a $13 price target, expecting significant commercial improvements by the end of 2025. Vanda has set its 2025 revenue guidance between $210 million and $250 million, indicating potential growth. Additionally, the FDA has accepted Vanda’s new drug application for tradipitant, aimed at treating motion sickness, with a decision expected by December 30, 2025. Vanda is also advancing VCA-894A, an ASO therapy for Charcot-Marie-Tooth disease Type 2S, which has received orphan designation from the FDA. Recent changes in executive compensation were disclosed, with adjustments to bonuses, salaries, and restricted stock units, aligning with industry standards.
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