Every 8-K that Vanda Pharmaceuticals Inc. (VNDA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow VNDA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full VNDA filings page.
Vanda Pharmaceuticals reported Q2 2026 total revenues of $50.5 million, down 4% year-over-year, as Fanapt net product sales grew 23% to $36.0 million while HETLIOZ declined 66% to $5.6 million. Net loss widened to $62.5 million (diluted loss per share $1.04) as R&D and SG&A spending increased.
Cash, cash equivalents and marketable securities totaled $170.0 million at June 30, 2026, and the company expects its resources and anticipated revenues to fund operations through at least the end of 2027. Management reiterated 2026 total revenue guidance of $240 to $290 million and highlighted FDA approval of milsaperidone for bipolar I disorder and schizophrenia, NEREUS commercial launch, an imsidolimab BLA with a December 12, 2026 PDUFA date, multiple Phase III readouts through early 2027, and ongoing proceedings to seek HETLIOZ approval for jet lag disorder.
Vanda Pharmaceuticals Inc. reported the results of its 2026 annual stockholder meeting held on June 4, 2026. Stockholders elected three Class II directors—Richard W. Dugan, Charles C. Duncan, Ph.D., and Anne Sempowski Ward—to serve until the 2029 annual meeting.
PricewaterhouseCoopers LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2026. Stockholders also approved, on an advisory, non-binding basis, the compensation of the company’s named executive officers and approved an amendment to the 2016 Equity Incentive Plan increasing the shares authorized for issuance.
A quorum was present, with 48,509,906 of 60,135,062 eligible common shares, or approximately 80.7%, represented in person or by proxy.
Vanda Pharmaceuticals reported Q1 2026 net product sales of $51.7 million, a 3% increase from Q1 2025, driven by 26% Fanapt® sales growth to $29.6 million. HETLIOZ® sales fell to $15.9 million, while PONVORY® rose to $6.2 million.
The company posted a net loss of $48.6 million (diluted loss per share $0.82), wider than the prior-year loss, reflecting higher selling, general and administrative spending and investments in launches and pipeline programs. Cash, cash equivalents and marketable securities totaled $202.3 million as of March 31, 2026.
Vanda raised its full-year 2026 revenue guidance to $240–$290 million, including $10–$30 million expected from newly launched NEREUS™. The quarter also featured FDA approval of BYSANTI™ (milsaperidone) for bipolar I disorder and schizophrenia and FDA acceptance of a BLA for imsidolimab in Generalized Pustular Psoriasis with a PDUFA target action date of December 12, 2026.
Vanda Pharmaceuticals Inc. expanded its Board of Directors from six to seven members and appointed Charles C. Duncan, Ph.D., as a Class II director, with his initial term running until the company’s 2026 annual stockholders’ meeting. Under Vanda’s outside director compensation program, Dr. Duncan received an initial restricted stock unit award with a grant date value of $390,000 as of April 22, 2026, vesting in four equal annual installments while he serves on the board, and he will receive a $50,000 annual cash fee paid quarterly. Beginning with the 2026 annual meeting, he will be eligible for additional annual restricted stock unit awards with a grant date value of $260,000, vesting one year from grant, with all such awards becoming fully vested upon a change of control. Vanda states that Dr. Duncan is an independent director and has entered into its standard Delaware law indemnification agreement for directors.
Vanda Pharmaceuticals Inc. reported that Timothy Williams has resigned as Senior Vice President, General Counsel and Secretary. He notified the company on March 29, 2026, and his resignation will be effective April 10, 2026, as he plans to pursue other endeavors.
Vanda Pharmaceuticals Inc. reported that its President, Chief Executive Officer and Chairman, Dr. Mihael Polymeropoulos, appeared on Fox Business’ Mornings with Maria to discuss pricing and commercial plans for a drug recently approved by the U.S. Food and Drug Administration to prevent vomiting caused by motion.
During the interview, he stated that Vanda is developing a direct-to-consumer channel to provide access to this drug and indicated that the channel is expected to be available in the next couple of months. The company furnished a link to the full televised interview for reference.
Vanda Pharmaceuticals reports that the FDA has approved BYSANTI (milsaperidone) tablets for adults with schizophrenia and for acute manic or mixed episodes in bipolar I disorder. The drug is an atypical antipsychotic and a new chemical entity that rapidly converts to iloperidone, showing bioequivalence across the therapeutic dosing range.
The company highlights that milsaperidone builds on extensive Fanapt (iloperidone) data, including more than 100,000 patient-years of real‑world use, offering a novel option with a familiar safety profile. It is also being studied as a once-daily adjunctive therapy in treatment‑resistant major depressive disorder, with that study expected to complete by year‑end.
Vanda anticipates commercial availability in Q3 2026 and expects marketing exclusivity supported by regulatory data protections and U.S. patents lasting to 2044. The label carries a boxed warning about increased mortality in elderly patients with dementia‑related psychosis and details multiple safety risks typical for atypical antipsychotics.
Vanda Pharmaceuticals detailed new pay and equity awards for its senior executives. The compensation committee granted 2025 cash bonuses, including $834,326 for CEO Mihael Polymeropoulos and amounts in the low $270,000 range for several other named officers.
For 2026, the CEO’s base salary was set at $994,625 with a target bonus of 80% of salary, while other named executives will earn base salaries of about $576,735–$596,990 with 45% bonus targets. The committee also granted substantial equity: the CEO received 525,000 RSUs and 175,000 target PSUs, and each other named officer received 125,000 RSUs and 40,000 target PSUs.
RSUs vest in four equal annual installments starting March 1, 2027. PSUs pay out between 50% and 150% of target based on relative total shareholder return versus the Nasdaq Biotechnology Index between December 31, 2025 and December 31, 2028, with any earned PSUs vesting on March 1, 2029.
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.
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) 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.