Eton Pharmaceuticals licenses LIBERVANT for $10M upfront

The licensing terms include a $10.0 million upfront fee, up to $47.5 million in milestones and mid-teens royalties on annual net sales.

Rhea-AI Filing Summary

Eton Pharmaceuticals, Inc. (ETON) acquired exclusive U.S. rights to commercialize LIBERVANT (diazepam) buccal film from Aquestive Therapeutics for seizure clusters in patients with epilepsy, subject to applicable regulatory approvals. Eton paid Aquestive a $10.0 million upfront license fee and is responsible for up to $47.5 million in aggregate regulatory and commercial milestone payments, plus royalties on annual net sales at a mid-teens percentage rate.

Aquestive will be the exclusive manufacturer and supplier, subject to specified exceptions, under a supply agreement with an initial 20-year term. LIBERVANT has tentative FDA approval for patients ages 2 to 5 and 12 and older; a separate application to add ages 6 to 11 is under FDA review with a March 29, 2027 target action date. Eton anticipates commercial availability in April 2027, subject to final FDA approval. The product has patent protection extending into 2038.

Filing Explained

Under its U.S. LIBERVANT license, Eton reports tentative FDA approval for patients 12 and older, while full-approval eligibility is expected following VALTOCO’s orphan-drug exclusivity expiration on January 10, 2027.

8-K Event Classification

3 items: 1.01, 2.01, 9.01

3 items

Item 1.01 Entry into a Material Definitive Agreement Business

The company signed a significant contract such as a merger agreement, credit facility, or major partnership.

Item 2.01 Completion of Acquisition or Disposition of Assets Financial

The company completed a significant acquisition or sale of business assets.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Upfront license fee: $10.0 million Regulatory and commercial milestone payments: Up to an aggregate of $47.5 million Royalty rate: Mid-teens percentage rate +5 more

8 metrics

Upfront license fee $10.0 million Paid by Eton to Aquestive under the license agreement

Regulatory and commercial milestone payments Up to an aggregate of $47.5 million Payments to Aquestive under the license agreement

Royalty rate Mid-teens percentage rate Royalties on annual net sales of LIBERVANT

Initial supply agreement term 20 years Initial term of the agreement with Aquestive

Automatic extension periods Three-year periods Succeeding terms of the supply agreement

Nonrenewal notice deadline At least two years Before the end of the initial or any succeeding term

PDUFA target action date March 29, 2027 Application to add ages 6 to 11 to the product label

Anticipated commercial availability April 2027 Subject to final FDA approval

Key Terms

tentative approval, Orphan Drug Designation, Type 9 New Drug Application (NDA), Prescription Drug User Fee Act (PDUFA), +1 more

5 terms

tentative approval regulatory

"granted tentative approval by the U.S. FDA"

A regulatory determination that an application (most commonly a generic drug application) meets the agency's standards for safety, efficacy and manufacturing quality but cannot be given full marketing approval immediately because of outstanding legal or administrative barriers (for example, patents or marketing exclusivity held by another product) or because a final administrative step remains. It means the product is approved on the merits and will be allowed to be marketed once the blocking condition is resolved or the final requirement is satisfied, but it does not itself permit commercial sale until that later trigger occurs.

Orphan Drug Designation regulatory

"LIBERVANT’s Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

Type 9 New Drug Application (NDA) regulatory

"a Type 9 New Drug Application (NDA) is under review"

Prescription Drug User Fee Act (PDUFA) regulatory

"Prescription Drug User Fee Act (PDUFA) target action date"

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

buccal film medical

"LIBERVANT (diazepam) buccal film"

A buccal film is a thin, flexible strip placed against the inside of the cheek that delivers a drug directly through the mouth’s lining into the bloodstream. Like a thin patch stuck inside your cheek, it can act faster, avoid breakdown in the stomach or liver, and improve patient convenience and adherence. For investors, buccal films can affect a drug’s market appeal, pricing, patent life, manufacturing complexity and regulatory pathway.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What are ETON's LIBERVANT license agreement payments?

Eton paid Aquestive a $10.0 million upfront license fee and is responsible for regulatory and commercial milestone payments of up to an aggregate of $47.5 million. Eton will also pay royalties on annual net sales at a mid-teens percentage rate.

When could ETON launch LIBERVANT?

Eton anticipates commercial availability in April 2027, subject to final FDA approval. LIBERVANT has tentative FDA approval for ages 2 to 5 and 12 and older. An application to add ages 6 to 11 is under FDA review with a March 29, 2027 PDUFA target action date.

How long does ETON's LIBERVANT supply agreement last?

Aquestive will be the exclusive manufacturer and supplier, subject to specified exceptions. The supply agreement has an initial 20-year term and automatically extends for succeeding three-year periods unless either party notifies the other of its desire not to renew at least two years before the end of the initial or succeeding term.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 10/14/2026 - 07:15 AM EDT Accepted by SEC EDGAR 10/14/2026 - 07:15 AM EDT Learn about SEC filing dates

false 0001710340 0001710340 2026-10-14 2026-10-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

October 14, 2026

Date of Report (Date of earliest event reported)

ETON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-38738	37-1858472
(State of	(Commission	(I.R.S. Employer
incorporation)	File Number)	Identification Number)

21925 W. Field Parkway, Suite 235

Deer Park, Illinois 60010-7208

(Address of principal executive offices) (Zip code)

(847) 787-7361

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		ETON		NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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.

2

Item 9.01: Financial Statements and Exhibits

Exhibit No.		Description
Exhibit 99.1		Press Release dated October 14, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

3

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 14, 2026	By:	/s/ Judith M. Matthews
		Judith M. Matthews
		Chief Financial Officer and Secretary
		(Principal Financial Officer)

4

Exhibit 99.1

     

Eton Pharmaceuticals and Aquestive Therapeutics Announce Exclusive U.S. Licensing Agreement for LIBERVANT® (diazepam) Buccal Film

● Differentiated, portable buccal film would offer patients and caregivers an alternative to existing nasal and rectal seizure rescue treatments, a market opportunity that exceeds $450 million annually in the U.S.

● Patient market research demonstrated strong preference for buccal film, with 71% of surveyed patients preferring film versus 13% for nasal spray, assuming equivalent efficacy

● Anticipated commercial launch in April 2027, subject to final FDA approval, provides a potential near-term growth opportunity and new commercial platform in neurology

● LIBERVANT has received Orphan Drug Designation and has issued patent protection extending into 2038, with additional patent applications pending with the U.S. Patent and Trademark Office

DEER PARK, Ill., and WARREN, N.J. October 14, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, and Aquestive Therapeutics, Inc. (“Aquestive”) (Nasdaq: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that they have entered into an exclusive license agreement and a supply agreement covering the United States and its territories for LIBERVANT® (diazepam) buccal film, an Orphan Drug-designated, differentiated treatment for seizure clusters in patients with epilepsy. Eton anticipates commercial availability of LIBERVANT in April 2027, subject to final U.S. Food and Drug Administration (FDA) approval.

The agreement grants Eton exclusive U.S. commercialization rights to LIBERVANT and adds a new growth driver to Eton’s expanding rare disease portfolio. The product builds on Eton’s experience commercializing differentiated dosage forms, engaging specialist physicians, and supporting patients and caregivers through treatment education, advocacy, and  programs designed to maximize therapy access and minimize affordability barriers.

“LIBERVANT marks an important expansion of our portfolio into neurology and represents a compelling opportunity to bring an orphan-designated, differentiated therapy to patients,” said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. “The U.S. seizure rescue market exceeds $450 million annually, and we believe LIBERVANT’s innovative buccal film technology, together with Eton’s experience commercializing differentiated dosage forms, positions us well to compete in this established market.

"By pairing Aquestive’s proprietary technology with Eton’s commercial capabilities and patient support services, we aim to provide physicians, patients, and caregivers an additional treatment option while building another durable source of growth for our shareholders. This agreement advances our strategy of acquiring and commercializing differentiated medicines, and we are excited to work with Aquestive toward an anticipated April 2027 launch,” concluded Brynjelsen.

“Today marks an important new chapter for LIBERVANT and for the epilepsy community,” said Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics. “I am confident that Eton’s focus on specialty medicines and patient access will be essential as we work toward making LIBERVANT available to the epilepsy community. This collaboration brings together complementary capabilities and provides a focused path to U.S. commercialization, allowing us to advance a product with the potential to address the needs of patients and caregivers seeking an alternative to nasal and rectal delivery.”  

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.

After viewing a video comparing film and nasal-spray packaging, 71% preferred or strongly preferred that their physician prescribe the film, compared with 13% for nasal spray, assuming both medicines worked equally well. These findings underscore patients’ interest in portability and treatment choice and reflect stated preferences, rather than comparative clinical outcomes.

About LIBERVANT

LIBERVANT is a buccal film formulation of diazepam, a benzodiazepine, developed for the acute treatment of seizure clusters that are distinct from a patient’s usual seizure pattern. The film is placed inside the cheek and dissolves without the need for a delivery device. LIBERVANT is intended as an intermittent rescue treatment and is not a replacement for daily maintenance antiseizure therapy. Its U.S. regulatory status and the age groups under review are described above

Important Safety Information

Do not give Libervant™ to your child if your child is allergic to diazepam or any of the ingredients in Libervant or has an eye problem called acute narrow angle glaucoma.

What is the most important information I should know about Libervant?

● Libervant is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:

o shallow or slowed breathing, 

o breathing stops (which may lead to the heart stopping), 

o excessive sleepiness (sedation). 

Do not allow your child to drive a motor vehicle, operate heavy machinery, or ride a bicycle until you know how taking Libervant with opioids affects your child.

● Risk of abuse, misuse, and addiction. Libervant is used in children 2 to 5 years of age. The unapproved use of Libervant has a risk for abuse, misuse, and addiction, which can lead to overdose and serious side effects including coma and death.

● Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in Libervant). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. 

o Your child can develop an addiction even if your child takes Libervant as prescribed by your child’s healthcare provider. 

o Give Libervant exactly as your child’s healthcare provider prescribed. 

o Do not share Libervant with other people.

o Keep Libervant in a safe place and away from children.

● Physical dependence and withdrawal reactions. Libervant is intended for use if needed in order to treat higher than usual seizure activity. Benzodiazepines, including Libervant, can cause physical dependence and withdrawal reactions, especially if used daily. Libervant is not intended for daily use.

o Do not suddenly stop giving Libervant to your child without talking to your child’s healthcare provider. Stopping Libervant suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures that will not stop (status epilepticus), sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, homicidal thoughts, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your child’s healthcare provider or go to the nearest hospital emergency room right away if your child gets any of these symptoms. 

o Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning, or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.

o Physical dependence is not the same as drug addiction. Your child’s healthcare provider can tell you more about the differences between physical dependence and drug addiction.

● Do not give your child more Libervant than prescribed or give Libervant more often than prescribed.
  

Libervant can make your child sleepy or dizzy and can slow your child’s thinking and motor skills.

● Do not allow your child to drive a motor vehicle, operate machinery, or ride a bicycle until you know how Libervant affects your child.

● Do not give other drugs that may make your child sleepy or dizzy while taking Libervant without first talking to your child’s healthcare provider. When taken with drugs that cause sleepiness or dizziness, Libervant may make your child’s sleepiness or dizziness much worse.

Like other antiepileptic medicines, Libervant may cause suicidal thoughts or actions in a small number of people, about 1 in 500.

● Call a healthcare provider right away if your child has any of these symptoms, especially if they are new, worse, or worry you: 

o thoughts about suicide or dying

o new or worse depression

o feeling agitated or restless

o trouble sleeping (insomnia)

o acting aggressive, being angry or violent

o other unusual changes in behavior or mood

o attempts to commit suicide

o new or worse anxiety or irritability         

o an extreme increase in activity and talking (mania)

o new or worse panic attacks

o acting on dangerous impulses

● Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.

● Keep all follow-up visits with your child’s healthcare provider as scheduled.

● Call your child’s healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If your child has suicidal thoughts or actions, your child’s healthcare provider may check for other causes.
  

What are the possible side effects of Libervant?

● The most common side effects of Libervant are sleepiness and headache.

● These are not all the possible side effects of Libervant.

● Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information about Libervant, talk to your doctor, and see Product Information: Medication Guide and Instructions For Use.

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eleven commercial rare disease products: KHINDIVI® (hydrocortisone), INCRELEX® (mecasermin), ALKINDI SPRINKLE® (hydrocortisone), DESMODA™ (desmopressin acetate), GALZIN® (zinc acetate), HEMANGEOL® (propranolol hydrochloride), PKU GOLIKE®, IMPAVIDO® (miltefosine), Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: AMGLIDIA® (glyburide), ASN-001, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.

About Aquestive

Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The worldwide leader in delivering trusted, quality medications on oral film, Aquestive operates as both a developer of its own proprietary products and a Contract Development and Manufacturing Organization (CDMO) for licensees, with its headquarters in New Jersey and U.S.-based manufacturing facilities in Indiana. The Company is the exclusive manufacturer of four commercialized products marketed by its licensees across six continents using proprietary, best-in-class technologies like PharmFilm®. Aquestive's AdrenaVerse™ platform contains a library of more than 20 epinephrine prodrugs enabling the pursuit of various potential allergy and dermatological indications. The Company is advancing Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, and AQST-108 (epinephrine) topical gel for various potential dermatological conditions.  For more information, visit Aquestive.com and follow us on LinkedIn

Forward Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding LIBERVANT’s potential commercial opportunity, contribution to Eton’s growth, anticipated approval and launch timing, potential label expansion, patent protection, and commercialization plans, the potential receipt by Aquestive of upfront, milestone and royalty payments, and Aquestive’s manufacture and supply of LIBERVANT. These statements reflect current expectations and involve risks and uncertainties that could cause actual results to differ materially. These include delays in or failure to obtain final FDA approval or label expansion; changes in regulatory requirements or the effect of competing products’ exclusivity; manufacturing or supply constraints; competition, pricing, reimbursement, and market acceptance; commercialization costs and execution; the scope, validity, and enforceability of intellectual property rights; whether and when milestone events are achieved, which depend on FDA approvals and Eton’s commercialization efforts; the amount of any royalties, which depends on net sales; Eton’s right to terminate the license agreement; and Aquestive’s ability to meet its supply obligations. Additional risks are described in Eton’s and Aquestive’s filings with the Securities and Exchange Commission. Neither company undertakes any obligation to update these statements except as required by law.

Eton Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793

E: lwilson@insitecony.com

Aquestive Investor Relations:
Brian Korb, astr partners
brian.korb@astrpartners.com

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 PRESS RELEASE RELATING TO LIBERVANT LICENSING AGREEEMENT 46.8 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.0 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.3 KB