Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) has announced the receipt of a decision letter from the U.S. Food and Drug Administration (FDA) regarding the supplemental new drug application (SNDA) for Hetlioz® (tasimelteon) for the treatment of jet lag disorder.
The FDA has concluded that the current form of the SNDA for Hetlioz® for the treatment of jet lag disorder cannot be approved. The decision stems from the FDA's re-review of the jet lag application under the October 1 collaborative framework agreement.
Vanda Pharmaceuticals Inc. respectfully disagrees with the FDA's interpretation. The company maintains that the submitted dataset meets the statutory standard for substantial evidence of effectiveness on clinically relevant endpoints for jet lag disorder.
In August 2025, the D.C. Circuit set aside a prior FDA refusal to approve Hetlioz® for jet lag disorder, describing Vanda's evidence as "specific, reasoned, and rooted in evidence." Following that ruling, Vanda and the FDA entered a collaborative framework agreement in October 2025, under which the FDA committed to an expedited re-review of the SNDA by January 7, 2026, including consideration of narrowed, sleep-focused indications.
Vanda Pharmaceuticals Inc. remains committed to working constructively with the FDA while pursuing all appropriate avenues to advance the approval of Hetlioz® for jet lag disorder.
Hetlioz® is a melatonin-receptor agonist, approved in the United States for the treatment of non-24-hour sleep-wake disorder and nighttime sleep disturbances associated with Smith-Magenis syndrome.
In terms of financial metrics, Vanda Pharmaceuticals Inc. reported total revenue of $62.5 million for the third quarter of 2025, representing a 13% increase compared to the same period in 2024. The company's net income for the third quarter of 2025 was $14.3 million, or $0.27 per diluted share, compared to a net loss of $2.2 million, or $0.04 per diluted share, for the same period in 2024.
Vanda Pharmaceuticals Inc. had cash, cash equivalents, and marketable securities totaling $221.8 million as of September 30, 2025, compared to $163.6 million as of December 31, 2024.
The company's research and development expenses for the third quarter of 2025 were $19.9 million, compared to $16.3 million for the same period in 2024. Selling, general, and administrative expenses for the third quarter of 2025 were $27.5 million, compared to $25.9 million for the same period in 2024.
Vanda Pharmaceuticals Inc. 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. As a result of these announcements, the company's shares have moved 1.88% on the market, and are now trading at a price of $7.04. If you want to know more, read the company's complete 8-K report here.
