Press Release: Santhera: AGAMREE(R) (vamorolone) -2-

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE(R) (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in Switzerland by Swissmedic, in China by the National Medical Products Administration (NMPA), in Hong Kong by the Department of Health (DoH) and in Canada by Health Canada. Santhera has out-licensed the rights to AGAMREE as follows: to Catalyst Pharmaceuticals for North America; to Sperogenix Therapeutics for China and certain countries in Southeast Asia; and to Nxera Pharma for Japan, South Korea, Australia, and New Zealand. For further information, please visit www.santhera.com.

AGAMREE(R) is a trademark of Santhera Pharmaceuticals.

For further information, please contact:

Santhera

Catherine Isted, Chief Financial Officer:

IR@santhera.com https://www.globenewswire.com/Tracker?data=MOP2ZvO9zfyk1rT6flyV41_KOUPmHMceLvtn3Y9s1NEAyctoVKTgu8zwVnjTwevmhCfk445Xc-3tGpZl1hhulcZ-78mf2tMwTXLZfP5zmcU=

ICR Healthcare:

Santhera@icrhealthcare.com https://www.globenewswire.com/Tracker?data=o-HhFr05hh7cUmgbxXrx05mlWN7AR0QZC1e8vCO-A1gOWgFnk3NKVHYcmGHae0YBL6gTMVHUX_TzhGHJUo4JGZ5dfoynA3oY1tUT_oZd3Hx5fA-1Z518QbMARUDYSh_G

Stifel

Brough Ransom, Charles Hoare, Fred Walsh

+44 (0)20 7710 7600

Octavian

Serge Monnerat, Marius Zuberbuehler

+41 (0)44 520 1588

Disclaimer / Forward-looking statements

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

# # #

Attachment

-- 260309 Santhera Guardian data at MDA Final_English (1)

https://ml-eu.globenewswire.com/Resource/Download/7b6f4aed-313e-4d93-b49e-36a6b64a9fa8

(END) Dow Jones Newswires

March 09, 2026 02:00 ET (06:00 GMT)