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WASHINGTON, Dec. 4, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant.

The lift followed Vanda’s formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative framework established between Vanda and the FDA in October 2025.

The FDA agreed with Vanda’s position that motion sickness is an acute, self-limiting physiologic response rather than a chronic or chronic-intermittent condition. The Agency therefore concluded that the use of tradipitant in motion sickness represents an acute, event-driven therapy, eliminating the need for an additional six-month dog toxicity study and rendering the partial clinical hold unnecessary.

This decision allows Vanda to extend clinical studies of tradipitant in motion sickness. Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025, positioning tradipitant as potentially the first new pharmacologic treatment for motion sickness in over 40 years.

“The swift and favorable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA,” said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. “We thank the Agency for its thorough and expedited scientific review and look forward to continued constructive dialogue.”

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.

About Tradipitant

Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for a variety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists. 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding Vanda’s further clinical development plans for tradipitant, Vanda’s pursuit of FDA approval of tradipitant for the prevention of vomiting induced by motion, the potential commercialization of tradipitant for such indication, and Vanda’s future interactions with the FDA are “forward-looking statements” under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda’s forward-looking statements include, among others, the FDA’s ability to complete its review of the NDA for tradipitant for the prevention of vomiting induced by motion by December 30, 2025, the FDA’s assessment of the evidence supporting the safety and efficacy of tradipitant for the prevention of vomiting induced by motion, and the ability of the FDA and Vanda to continue to work together collaboratively. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized, or even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda’s business and market, particularly those identified in the “Cautionary Note Regarding Forward-Looking Statements”, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vanda’s most recent Annual Report on Form 10-K, as updated by Vanda’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
[email protected]

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
[email protected]

SOURCE Vanda Pharmaceuticals Inc.

This fuel will be used for the Project Pele microreactor being developed through a collaboration among the three parties (alongside the Department of Energy) and represents a major milestone for the project. As Jeff Waksman, Principal Deputy Assistant Secretary of the Army for Installations, Energy and Environment, put it, “This is real nuclear microreactor fuel delivered at its final destination, rather than some letter or memorandum promising to make fuel at a later date.”

More details: According to INL—and despite announcements coming out this week—the 40,000 fuel compacts that made up the shipment were delivered on November 5 (a video of the delivery is available here). BWXT manufactured and shipped the fuel from its facilities in Lynchburg, Va., where the company is also constructing the prototype reactor.

BWXT plans to begin formal system testing as early as 2027 and begin producing electricity at INL as soon as 2028.

While the SCO is leading Project Pele, INL director John Wagner highlighted how instrumental the DOE network has been in facilitating this project, saying, “This milestone reflects years of dedicated effort by the Office of Nuclear Energy’s Advanced Gas Reactor TRISO Fuel Qualification Program to fabricate and qualify TRISO fuel using world-class capabilities at INL’s Advanced Test Reactor and Materials and Fuels Complex, and Oak Ridge National Laboratory—capabilities that exist nowhere else in the world.”

Pele background: In May 2019, the Nuclear Regulatory Commission, DOE, and SCO signed a preliminary MOU on microreactor research laying the groundwork for Project Pele. The original goal of the project was to develop a transportable 1–5 MWe advanced microreactor.

In March 2020, the DOD awarded contracts for three projects under Pele: one to BWXT, one to Westinghouse, and one to X-energy. BWXT emerged as the frontrunner in the project with its 1.5-MWe high-temperature, gas-cooled reactor.

In August 2023 (in a webinar organized by the American Nuclear Society), Waksman said that if all went according to plan, the reactor would be turned on at INL before the end of calendar year 2025. The new operational date of 2028 represents a three-year delay in prior plans but still aims to meet a September 30, 2028, deadline set by President Trump’s Executive Order 14299.

In September 2024, the DOD announced that it had broken ground at INL’s Critical Infrastructure Test Range Complex, where the reactor is set to be tested. In July 2025, BWXT announced that it had started fabrication on the Pele reactor core.

Janus tie-in: Project Pele—of course— is not the only nuclear power–related undertaking of the DOD or the broader federal government. Most directly related is the recently announced Janus Program, which seeks to deploy an operational demonstration microreactor power plant on a U.S. military installation by 2030. The DOD has stated that Janus will build on lessons learned from Pele and that the “laboratory teams which partnered on the technical, legal, and policy aspects of Project Pele will also be working closely on the Janus Program.”

Waksman reiterated this most recently in BWXT’s announcement, saying, “the army’s Janus Program will follow on to deliver affordable, reliable, commercial nuclear power to ensure that our critical infrastructure has power, even if the electric grid is disrupted.” In November, nine sites were selected for possible deployment as part of the program.

Don’t forget ANPI: Project Pele and the Janus Program are running parallel to the DOD’s separate Advanced Nuclear Power for Installations (ANPI) program, which was launched in 2024 to deploy microreactor systems at military sites. At the launch of the program, the DOD aimed to have two microreactors operational on military bases by 2030. In April of this year, the DOD announced eight companies that are eligible to receive Other Transaction Awards for the project.

At this year’s annual conference of the Association of the U.S. Army, Waksman reportedly said that Janus will differ from ANPI by virtue of having different technical requirements, reflecting recent changes in the nuclear power market, including new companies that have emerged since last year.