MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, received a communication from the FDA indicating concern on findings from a recently completed study in rats as well as CNS events at higher doses in dogs, and the potential implication of these findings for patients. This led the FDA to request Newron to delay initiation of the proposed Phase II/III pivotal studies with evenamide for the treatment of schizophrenia prior to completing additional short-term explanatory studies in rats and human subjects to address these concerns.
The start of the proposed phase II/III studies will therefore be delayed until after the discussion of the results of such studies with the FDA and making necessary changes in the planned pivotal studies. Newron will be asking for further feedback in a meeting with the FDA shortly and will provide additional details and an update on evenamide afterwards. Ravi Anand, MD, Chief Medical Officer of Newron, stated: “Based on the issues raised by the FDA letter, Newron is confident that they can be addressed satisfactorily.”
Newron management offers a conference call for investors, analysts and journalists on Tuesday, May 28, 3:00 pm CEST/9 am EST. The conference call can be accessed via the following dial-in numbers:
- Switzerland/Europe: +41 (0) 58 310 50 00
- United Kingdom: +44 (0) 207 107 0613
- United States: +1 (1) 631 570 5613
- Italy: +39 (0) 2 805 88 20
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The company is headquartered in Bresso near Milan, Italy. Xadago® (safinamide) has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the US, Australia, Canada, Brazil, and Colombia and is commercialized by Newron’s partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago® for Parkinson’s disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com
Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’ s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.
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