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 |
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