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Nanexa’s clinical trial application for NEX-22 Phase I study assessed by EMA

Nanexa AB today announces that the Clinical Trial Application for the Phase I study of NEX-22 in patients with type 2 diabetes has been received and validated by the European Medicines Agency (EMA).

"EMA has now made its validation of the application as a first step and Nanexa is entering the process where we are expected to answer questions on the documentation and data that form the basis of the application. Our goal is to be able to start the Phase I study based on an approval in the first quarter of 2024, which we really look forward to", says David Westberg, CEO of Nanexa.

For additional information, please contact:

David Westberg – CEO, Nanexa AB (publ) 
Phone: +46 70 942 83 03
Email: david.westberg@nanexa.se
www.nanexa.com

The company’s Certified Adviser is Carnegie Investment Bank AB (publ).

About Nanexa AB (publ)

Nanexa is a pharmaceutical company developing injectable drug products based on the proprietary and innovative drug delivery system PharmaShell® – the high drug load delivery system enabling the next generation long-acting injectables through atomic layer precision. Nanexa develops its own products and also has collaboration agreements with several pharma companies, among others Novo Nordisk and AstraZeneca.

Nanexa’s share is listed on Nasdaq First North Growth Market in Stockholm (NANEXA).

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Nanexa’s clinical trial application for NEX-22 Phase I study assessed by EMA

Datum 2023-12-20, kl 08:00
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Nanexa’s clinical trial application for NEX-22 Phase I study assessed by EMA