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Item 1.01: Entry into a Material Definitive Agreement On October 13, 2026, Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) entered into a license agreement (the “License Agreement”) with Aquestive Therapeutics, Inc. (“Aquestive”) pursuant to which the Company acquired exclusive U.S. rights to commercialize LIBERVANT® (diazepam) buccal film (the “Product”) for the acute treatment of seizure clusters in patients with epilepsy, subject to applicable regulatory approvals. The Product has received tentative approval from the U.S. Food and Drug Administration (“FDA”) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age and ages 12 and older.
Under the terms of the License Agreement, the Company paid Aquestive an upfront license fee of $10.0 million. In addition, the Company is responsible for regulatory and commercial milestone payments to Aquestive of up to an aggregate of $47.5 million as follows:
$10.0 million upon first commercial sale in the United States, reduced to $5.0 million if full FDA approval permitting commercial sale for ages 2–5 has not been received.
$2.5 million upon approval by the FDA of the Product for patients ages 6–11 Up to $35 million of commercial milestones tied to Product’s achievement of certain annual net sales levels in the United States The Company will also pay Aquestive royalties on annual net sales of the Product at a mid-teens percentage rate.
In connection with the License Agreement, the Company also entered into a supply agreement with Aquestive (the “Supply Agreement”) under which Aquestive will serve as the exclusive manufacturer and supplier of the Product, subject to specified exceptions. The Supply Agreement provides for an initial term of 20 years. At the conclusion of such initial term, the Supply Agreement will be subject to an automatic extension for succeeding three-year periods unless either party notifies the other of its desire not to renew at least two years prior to the end of the initial term or any succeeding term.
A copy of the press release announcing the transaction dated October 14, 2026 is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 2.01: Completion of Acquisition or Disposition of Assets As disclosed in Item 1.01, on October 13, 2026, the Company entered into an exclusive license agreement and a supply agreement covering the United States and its territories for LIBERVANT® (diazepam) buccal film , an orphan-designated, differentiated treatment for seizure clusters in patients with epilepsy with Aquestive. The information in Item 1.01 is hereby incorporated by reference into this Item 2.01.
Building on Eton ’ s Rare Disease Foundation LIBERVANT’s Orphan Drug Designation and specialist treatment setting complement Eton’s focus on medicines requiring targeted education, patient support, and close engagement with healthcare professionals and patient advocacy groups. The agreement also builds on Eton’s experience supporting pediatric patients and families, where treatment decisions often involve caregivers and confidence in administration is important.
Eton plans to establish a dedicated neurology team supported by its existing commercial infrastructure. Its commercialization approach will draw on experience acquiring and relaunching specialty medicines, including INCRELEX, GALZIN, and HEMANGEOL, as well as established capabilities in advocacy partnerships, community engagement, and treatment education.
Regulatory Status and Anticipated Launch The U.S. FDA granted LIBERVANT Orphan Drug Designation in November 2016. LIBERVANT currently has been granted tentative approval by the U.S. FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above. The product is expected to become eligible for full approval in patients 12 years of age and above following the scheduled expiration of VALTOCO®’s orphan drug exclusivity on January 10, 2027. In addition, a Type 9 New Drug Application (NDA) is under review with the U.S. FDA to add ages 6 to 11 to the product’s label. The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027. If approved, the application would expand the potential labeled population to patients ages 6 and older. Eton anticipates the product being commercially available in April 2027, subject to final FDA approval.
LIBERVANT has issued patent protection extending into 2038 and additional patent applications are pending with the U.S. Patent and Trademark Office.
Patient Research Highlights the Importance of Portability and Treatment Choice Third-party market research highlights a gap between patients’ desire to keep seizure-cluster medication close and their reported carrying habits. Among 101 patients surveyed, 76% were somewhat or highly concerned about not having their medication within arm’s reach when away from home, yet only 34% reported always carrying it outside the home.