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Vanda Pharmaceuticals reported full year 2025 total revenues of $216.1 million, up 9%, led by Fanapt net product sales of $117.3 million, a 24% increase. HETLIOZ and PONVORY sales declined modestly for the year.
GAAP net loss widened to $220.5 million from $18.9 million, driven largely by a one-time, non-cash income tax charge of $113.7 million related to a valuation allowance against deferred tax assets. Cash, cash equivalents and marketable securities were $263.8 million as of December 31, 2025.
Operationally, the FDA approved NEREUS (tradipitant) for prevention of motion-induced vomiting, while Bysanti (milsaperidone) has a PDUFA target action date of February 21, 2026 and an imsidolimab BLA for generalized pustular psoriasis was submitted. For 2026, Vanda projects total revenues of $230–$260 million, including Fanapt net product sales of $150–$170 million.
BlackRock Portfolio Management LLC has filed an amended Schedule 13G reporting a beneficial ownership stake in Vanda Pharmaceuticals Inc. common stock. The firm reports beneficial ownership of 3,251,563 shares, representing 5.5% of the class as of the event date 12/31/2025. BlackRock Portfolio Management LLC has sole voting power over 2,796,972 shares and sole dispositive power over 3,251,563 shares, with no shared voting or dispositive power.
The filing explains that the holdings are aggregated from certain BlackRock business units and are held in the ordinary course of business. It also certifies that the securities were not acquired for the purpose of changing or influencing control of Vanda Pharmaceuticals Inc., indicating a passive investment position under the Schedule 13G framework.
Vanda Pharmaceuticals Inc. received an amended Schedule 13G/A from Millennium Management LLC, Millennium Group Management LLC, and Israel A. Englander reporting a passive ownership position. The group reports beneficial ownership of 1,679,013 shares of Vanda common stock, representing 2.8% of the outstanding class as of the 12/31/2025 event date. All voting and dispositive power over these shares is reported as shared, with no sole voting or dispositive power. The filers state that the securities were not acquired and are not held for the purpose of changing or influencing control of Vanda, but instead are held on a passive basis.
Vanda Pharmaceuticals reports that the U.S. Food and Drug Administration has completed an expedited re-review of its supplemental New Drug Application for HETLIOZ as a treatment for jet lag disorder and concluded the application cannot be approved in its current form. This re-review was conducted under a previously announced collaborative framework between Vanda and the FDA, with a target date of January 7, 2026. The decision represents a setback for Vanda’s efforts to add jet lag disorder as a new indication for HETLIOZ. Vanda issued a press release on January 8, 2026, and has attached the full text as an exhibit.
Vanda Pharmaceuticals (VNDA) reported a larger quarterly loss despite higher sales. Net product sales were $56.3 million in Q3 2025, up from $47.7 million a year ago. Sales by product: Fanapt $31.2 million, HETLIOZ $18.0 million, and PONVORY $7.0 million.
Operating expenses rose sharply, with selling, general and administrative at $60.3 million (from $37.6 million) and research and development at $22.6 million (from $16.8 million). Loss from operations was $31.3 million; net loss was $22.6 million, or $0.38 per share. For the nine months, revenue reached $158.9 million with a net loss of $79.3 million. Operating cash flow was an outflow of $80.0 million year-to-date.
Liquidity remained significant: cash and cash equivalents were $70.0 million and marketable securities were $223.7 million as of September 30, 2025. Total assets were $601.1 million and stockholders’ equity was $466.0 million. The company noted HETLIOZ sales may be variable and could decline in future periods related to generic competition. Shares outstanding were 59,096,630 as of October 23, 2025.
Vanda Pharmaceuticals (VNDA) furnished an 8‑K stating it issued a press release and is holding a conference call regarding results of operations and financial condition for the quarter ended September 30, 2025.
The press release is included as Exhibit 99.1 and, along with Item 2.02, is furnished and not deemed “filed” under the Exchange Act. The company also included standard forward‑looking statements cautions, directing readers to risk factors in its periodic SEC reports.
Vanda Pharmaceuticals Inc. reported that it has reached a collaborative framework with the U.S. Food and Drug Administration to resolve certain disputes involving its drugs HETLIOZ® (tasimelteon) and tradipitant. This means the company and the FDA have agreed on a structured approach to address outstanding regulatory disagreements related to these products.
The company announced this development in a press release dated October 1, 2025, which is referenced as an exhibit. While specific terms or outcomes are not described here, the framework focuses on moving toward resolution of the disputes regarding these two drugs.
Mihael H. Polymeropoulos, identified as President and CEO (also listed as a director and chairman), reported a purchase of 10,000 shares of Vanda Pharmaceuticals common stock on 08/07/2025 at $4.15 per share. After this purchase he beneficially owns 2,335,731 shares. The Form 4 discloses a direct insider buy by the company’s chief executive, increasing his reported stake.