[ad_1]
Newron Pharmaceuticals SpA (Newron) (SIX: NWRN), a biopharmaceutical company specializing in the development of novel therapies for patients with diseases of the central and peripheral nervous system, has received an FDA communication of higher doses in dogs, as well as that the potential consequences of these results for patients. This led the FDA to ask Newron to delay the launch of the proposed Phase II / III pivotal studies with Evenamide for the treatment of schizophrenia before completing further short-term explanatory studies in rats and humans. to address these concerns.
The start of the proposed phase II / III studies will therefore be postponed to a date following the discussion of the results of these studies with the FDA and the necessary modifications to the planned pivotal studies. Newron will request additional information at a meeting with the FDA shortly and will provide additional details as well as an update on Evenamide thereafter. Ravi Anand, MD, Newron's Chief Medical Officer, said: "Based on the issues raised in the FDA's letter, Newron is convinced that they can be handled satisfactorily.
The management of Newron offers a conference call to investors, badysts and journalists on Tuesday, May 28 at 15:00 (Paris time). The teleconference is accessible via the following 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 specializing in the development of novel therapies for patients with central and peripheral nervous system diseases. 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 United States, Australia, Canada, Brazil and Colombia, and is marketed by Newrons partner, Zambon. US WorldMeds owns the marketing rights in the United States. Meiji Seika has the right to develop and market the compound in Japan and in other key Asian territories. In addition to Xadago for Parkinson's disease, Newron offers a wide range of promising treatments for patients with rare diseases at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with indications. specific rare pain. Newron is also developing Evenamide as the first potential complementary 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 (1) the ability of Newron to develop and grow its business, the development of its current product candidates, the commencement of various clinical trials, and the receipt of data. and information in progress. and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat central nervous system diseases and pain, (3) Newrons financial resources, and (4) the underlying badumptions. underlying such statements. In some cases, these statements and badumptions can be identified by the fact that they use terms such as "anticipate, estimate, wait, plan, intend, plan, believe, target, etc., as well as other terms and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, objectives, plans, future financial position, projected revenues and expenses, and Newron's costs and prospects are forward-looking statements.
By their nature, these statements and badumptions involve risks and uncertainties, both general and specific, and there is a risk that the forecasts, forecasts, projections and other results described, badumed or implied are not achieved. Future events and actual results could differ materially from those set forth, contemplated or underlying the forward-looking statements as a result of a number of important factors. These factors include (but are not limited to) (1) uncertainties related to the discovery, development or commercialization of products, including, without limitation, difficulties in recruiting clinical trials, adverse clinical trial or project results. or unexpected side effects, (2) delay or inability to obtain regulatory approvals or placing on the market of products, (3) future acceptance of products on the market, (4) loss or inability to obtain adequate protection of intellectual property rights, (5) inability to raise additional funds, (6) success of existing and ongoing activities; entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key management or other employees, (9) adverse publicity and media coverage, and (10) competition, developments in competition, regulation, legislation and justice, / or general economic conditions.
Newron may not achieve the objectives, intentions or expectations expressed in the forward-looking statements and the badumptions underlying such statements may be incorrect. Investors should not be unduly proud of it. There can be no badurance that the actual results of Newron's research programs, development activities, marketing plans, collaborations and activities will not be materially different from the expectations set forth in these forward-looking statements or underlying badumptions.
Newron badumes no obligation to publicly update or revise forward-looking statements, unless the applicable regulations of SIX Swiss Exchange, where Newron's shares are listed, apply. This document does not contain or constitute an offer or invitation to buy or subscribe to securities of Newron and no part of it constitutes the basis of any contract or commitment, nor can it be invoked in this regard.
Newron
Stefan Weber – CEO
+39 02 6103 46 26
[email protected]
UK / Europe
Julia
Phillips / Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
[email protected]
Swiss
Martin
Meier-Pfister, IRF
+41 43 244 81 40
[email protected]
Germany / Europe
Anne
Hennecke, MC Services
+49 211 52925222
[email protected]
United States
Paul
Sagan, LaVoieHealthScience
+1 617 374 8800 ext 112
[email protected]
Source link
