Press Release

Dysport® is the first botulinum toxin to achieve positive topline Phase III results in both episodic and chronic migraine.

• Dysport® achieved statistically significant topline Phase III results, meeting primary endpoints in both episodic (E-BEOND) and chronic (C-BEOND) migraine
• Dysport is the first botulinum toxin in episodic migraine to demonstrate a statistically significant reduction in monthly migraine days
• Dysport was well-tolerated across both trials with safety consistent with the known profile

PARIS, FRANCE – 9 JULY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced positive topline results from its Phase III BEOND migraine program evaluating Dysport® (abobotulinumtoxinA) for the prevention of episodic (E-BEOND) and chronic migraine (C-BEOND) in adults. Both the E-BEOND and C-BEOND trials met their primary endpoints, a reduction in monthly migraine days versus placebo. The E-BEOND results represent the first Phase III trial in which a botulinum toxin has demonstrated statistically significant efficacy in episodic migraine. Together with the positive C-BEOND results, BEOND is the first Phase III clinical program to demonstrate efficacy of a botulinum toxin in the prevention of both episodic and chronic migraine.

Dysport was well-tolerated. Safety findings observed across both trials were consistent with well-established use of Dysport in approved indications, with no new or unexpected signals identified.

"These results represent a significant advance in the development of botulinum toxin therapies for migraine," said Christelle Huguet, PhD, EVP and Global Head of R&D. "BEOND is the first Phase III program to demonstrate efficacy of a botulinum toxin in both episodic and chronic migraine. Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population."

Migraine remains a common neurological disorder with a high unmet medical need. Migraine can be severely debilitating for people living with the condition and may have life-long impacts, frequently disrupting their ability to work, to plan or enjoy a social life. Episodic migraine (defined in the E-BEOND trial as experiencing up to 14 headache days per month of which at least 6 were migraine days) is a substantially larger patient population than chronic migraine (defined as experiencing headaches on 15 or more days per month, with at least 8 migraine days).

“These Phase III topline results position Dysport as the first botulinum toxin to demonstrate efficacy for both episodic and chronic migraine prevention, supporting an advance in treatment options for patients,” said Dr. Cristina Tassorelli, MD, Professor and Chair of Neurology and Director of the Department of Brain and Behavioral Sciences at the University of Pavia, based in Pavia, Italy and Principal Investigator for the C-BEOND trial.

"Preventive treatment options for episodic migraine remain limited. These clinical trial results are encouraging because they suggest a potential new preventative therapy that, if approved, may benefit a broad group of patients,” said Dr. Jessica Ailani MD, Clinical Professor of neurology at MedStar's Georgetown University Hospital and Director of the MedStar Georgetown Headache Center, based near Washington DC, and Principal Investigator for the E-BEOND trial.

Detailed findings from the BEOND program will be presented at a future scientific congress.

About the DYSPORT BEOND PHASE III migraine program

The BEOND Phase III program included two randomized, multi-center, placebo-controlled trials, C-BEOND (NCT06047444) and E-BEOND (NCT06047457). The trials enrolled 1,510 patients across 120 centers. The primary endpoint for both trials was the change from baseline in the number of monthly migraine days at week 24 (measured over weeks 21 to 24). The Extension Phase of the BEOND trials, where all participants receive Dysport for two treatment cycles, will continue to week 48.

About Migraine

Migraine is a complex neurological disease characterized by recurrent attacks of headache and migraine, and is estimated to impact approximately 14% of the world’s population¹. People living with migraine experience symptoms that include recurring throbbing headache pain, nausea, vomiting, and sensitivity to light, sound, touch and smell. These symptoms can have a life-long impact on the person as well as their families. Migraine can be categorized as episodic migraine or chronic migraine. People living with chronic migraine experience 15 or more headache days per month, of which at least 8 are migraine days. People living with episodic migraine can experience up to 14 headache days per month of which at least 6 are migraine days (as defined in the E-BEOND trial).

About Dysport

Dysport® (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in approximately 90 countries, more than 30 years of clinical experience and >21 million treatment years of patient experience.

The detailed recommendations for the use of Dysport® are described in the Summary of Product Characteristics (SmPC) and the U.S. Prescribing Information (PI) for Dysport (300 units) Powder and Dysport (500 units) Powder.

NOTE: Dysport® labels and approved indications may vary from country to country.

About Ipsen

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

Ipsen Contacts

Investors
Henry Wheeler henry.wheeler@ipsen.com +33 7 66 47 11 49
Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26

Media
Sally Bain sally.bain@ipsen.com +1 857 320 0517
Anne Liontas anne.liontas.ext@ipsen.com +33 7 67 34 72 96

Disclaimers and/or forward-looking statements

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