EQS-Adhoc

Newron announces Half-Year 2021 results

EQS Group-Ad-hoc: Newron Pharmaceuticals SpA / Key word(s): Half Year Results Newron announces Half-Year 2021 results 16-Sep-2021 / 07:01 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement. Ad hoc announcement pursuant to Art. 53 LR

Milan, Italy, September 16, 2021, 07:00 am CEST - Newron Pharmaceuticals S.p.A. ('Newron') (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its operational highlights and financial results for the half-year ended June 30, 2021.

Highlights:
Evenamide (Schizophrenia) 

• The primary objective of two short-term explanatory studies of evenamide was met on all safety variables: study 010, in healthy volunteers, and study 008, in patients with schizophrenia
• Post-period, Newron initiated study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia, results from which are expected by Q4 2022
• Newron continues to evaluate strategic commercial and development partnering options for evenamide

Xadago(R)/safinamide (Parkinson's disease)

• Newron signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in Parkinson's disease patients with levodopa-induced dyskinesia (PD LID)
• Newron is currently working on finalizing the design of the study with international clinical experts and regulatory authorities and intends to initiate the study in Q1 2022
• Newron and its partners Zambon and Supernus are responding appropriately to protect the intellectual property rights relating to Xadago(R)/safinamide in the US, following some Paragraph IV Notice Letters regarding Abbreviated New Drug Applications that have been submitted by generic manufacturers

Corporate