Eton Pharmaceuticals Expands Rare Disease Portfolio Through Agreement for U.S. Commercialization Rights to IMPAVIDO® (miltefosine) (Form 8-K)

Eton Pharmaceuticals Expands Rare Disease Portfolio Through Agreement for U.S. Commercialization Rights to IMPAVIDO® (miltefosine)

DEER PARK, Ill., MAY 19, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or "the Company") (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced it has entered into a supply and distribution agreement for the United States commercialization rights to IMPAVIDO® (miltefosine) from an affiliate of Knight Therapeutics, Inc ("Knight"). IMPAVIDO® is an orphan drug indicated for the treatment of visceral, cutaneous, and mucosal leishmaniasis caused by specific Leishmania species in adults and adolescents over the age of 12 and weighing more than 30 kilograms. Please see indications and important safety information below.

"We are excited to add yet another 2026 product launch to our portfolio. IMPAVIDO® is a critical, life-saving medication and a strong fit with Eton's orphan-focused commercial model. We look forward to partnering with Knight to ensure reliable, high-touch access to the medication for patients across the United States and serving this important community," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Leishmaniasis is a rare, potentially life-threatening parasitic disease caused by Leishmania parasites transmitted through the bite of infected sand flies. The disease can present in several forms, including cutaneous leishmaniasis, which commonly causes skin sores; mucosal leishmaniasis, which can affect the nose, mouth, or throat; and visceral leishmaniasis, the most severe form, which affects internal organs and can be life threatening if untreated. IMPAVIDO® has been commercially available in the United States since 2016.

The transaction further expands Eton's growing portfolio of orphan therapies serving highly specialized patient populations and reflects the Company's continued focus on expanding differentiated rare disease commercialization and patient support capabilities across multiple therapeutic areas.

Important Safety Information for IMPAVIDO®

Indication for IMPAVIDO® (miltefosine)

IMPAVIDO® capsules contain the active ingredient miltefosine, an antileishmanial agent.

IMPAVIDO® is an antileishmanial drug indicated in adults and pediatric 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for treatment of:

Limitations of use: Leishmania species evaluated in clinical trials were based on epidemiologic data. There may be geographic variation in the response of the same Leishmania species to IMPAVIDO®. The efficacy of IMPAVIDO® in the treatment of other Leishmania species has not been evaluated.

Important Safety Information for IMPAVIDO® (miltefosine):

IMPAVIDO® may cause serious risks to pregnancy:

Pregnancy Registry: There is a registry for women who become pregnant during treatment with IMPAVIDO®. If you become pregnant or think you may be pregnant while taking IMPAVIDO®, tell your healthcare provider right away. Talk to your healthcare provider about registering with the IMPAVIDO® Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby's health. Your healthcare provider can enroll you in this registry by calling 1-866-588-5405 Do not take IMPAVIDO® if you:

The most common side effects associated with IMPAVIDO® include nausea, vomiting, diarrhea, stomach pain, decreased appetite, dizziness, headache, sleepiness, skin itching, abnormal liver tests, abnormal kidney tests, motion sickness, fever, tiredness, weakness, and enlarged lymph nodes.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMPAVIDO®. For more information, ask your healthcare provider.

You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all of the medicines you're taking, including prescription and over-the-counter medications, vitamins and herbal supplements.

Tell your healthcare provider about all your medical conditions, including if you have or have had eye problems, have kidney or liver problems. Your healthcare provider should do blood tests to check your kidneys and liver before you start, during and after your treatment with IMPAVIDO®. If you are breastfeeding or plan to breastfeed. It is not known if IMPAVIDO® passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take IMPAVIDO®. You should not breastfeed while you take IMPAVIDO® and for 5 months after your last dose of IMPAVIDO®.

IMPAVIDO® has not been studied in children under 12.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

IMPAVIDO® is available by prescription only. The information on this website should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about IMPAVIDO®, talk to your doctor or healthcare professional and see the full prescribing information

About Eton Pharmaceuticals

Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has ten commercial rare disease products: KHINDIVI^TM, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.