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History

History

2016

  • Xadago® (safinamide) launched by Zambon for patients with Parkinson’s disease in ten additional European countries (Switzerland, Spain, Italy, Belgium, Denmark, Sweden, the U.K., Luxembourg, the Netherlands and Norway)
  • Re-submission of the New Drug Application (NDA) for Xadago® expected in 2016, following US FDA clearance
  • Phase II study of Evenamide (NW-3509) presented at the 5th Biennial Schizophrenia International Research Society Conference 
  • Investigational New Drug application for sarizotan for the treatment of Rett syndrome approved by the US FDA 
  • “Sarizotan Treatment of Apneas in Rett Syndrome” (STARS) potentially pivotal trial design presented at US Rett Syndrome Symposium – study initiated in July 
  • Burden of Disease study initiated with International Advisory Board meeting at 2016 Rett Syndrome Foundation Meeting

 

2015

  • Newron initiates U.S. Phase II trial in patients with schizophrenia
  • Newron Completes 5.4 Million USD/CHF Private Placement with U.S. Biotechnology/Healthcare Specialist Fund
  • Swissmedic approves Xadago® for use in Parkinson’s disease
  • Newron Receives Orphan Drug Designation for Sarizotan from EMA’s COMP and FDA
  • Launches Xadago® (Safinamide) For Patients With Mid- To Late-Stage Parkinson’s Disease In Germany
  • Newron Completes CHF24.3M/US$25.5M in Private Placement from Leading EU and US Investors
  • Xadago®(safinamide) New Drug Application (NDA) Accepted for Filing by the U.S. Food and Drug Administration (FDA)
  • EU Commission approves Xadago® (safinamide) for mid-late stage PD patients
  • Initiation of  Phase II study of sNN0029 in patients with Amyotrophic Lateral Sclerosis
  • Results of Phase I study of NW-3509
  • Initiation of Phase II study of sNN0031 in patients with Parkinson’s disease

 

2014

  • Safinamide New Drug Application (NDA) re-submitted to the US Food and Drug Administration (FDA)
  • CHMP recommends approval of XadagoTM (safinamide) to treat Parkinson´s disease in the EU
  • Refusal to File letter received from US FDA for safinamide, based on organization and navigation problems
  • Newron shares to be included into the SXI Life Sciences® and the SXI Bio+Medtech® indices
  • Start of US operations
  • Safinamide New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA) 
  • New results with NW-3509 presented at the 4th Biennial Schizophrenia International Research Society (SIRS) Conference
  • CHF 18.6 million raised in private placements to existing and new institutional shareholders in Europe and the USA
  • Safinamide Application for Authorization submitted to Swissmedic (by Zambon)

 

2013

  • Safinamide Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA)
  • Newron receives €2.5m Strategic Translation Award from Wellcome Trust to develop experimental drug candidate for ALS
  • Full disclosure of safinamide Phase III results at AAN, MDPD and MDS conferences
  • Newron and Zambon progressing towards regulatory filing for marketing authorization of safinamide in the USA

 

2012

  • Newron signs licence agreement with Meiji Seika Pharma on safinamide covering Japan and other key Asian territories
  • Newron and Zambon enter into a strategic collaboration and licence agreement for safinamide covering global rights excluding Japan and other key Asian territories
  • Successful completion of the Phase III development programme for safinamide as an add-on therapy for Parkinson’s disease
  • Acquisition of NeuroNova
  • Notice of Allowance issued for safinamide combination patent by USPTO extending protection through 2026, plus potential extension of up to five years

 

2011

  • US FDA IND approval for NW-3509
  • FDA approves ralfinamide trial in non-responding patients with severe neuropathic pain of specific causes
  • Newron regains global rights to safinamide from Merck Serono
  • Newron licenses rights to two compounds for CNS diseases from Merck for further evaluation ahead of new Phase II studies

 

2010 

  • Results of a long-term study of safinamide as add-on treatment to levodopa in advanced Parkinson’s disease announced by Newron and Merck Serono
  • An independent US Advisory Board recommends evaluation of ralfinamide in other pain conditions after inconclusive results were seen with ralfinamide in the SERENA Phase IIb/III study

 

2009 

  • Phase III trial of safinamide shows significant improvement of motor function in patients with advanced Parkinson’s disease

 

2008

  • Acquisition and integration of Hunter-Fleming Ltd
  • Initiation of Phase IIb/III study of ralfinamide in patients with Neuropathic Low Back Pain
  • Italian government grant (€5m)

 

2007

  •  Opening of clinical development subsidiary in Basel

 

2006

  • Newron signs global development and commercialisation agreement for safinamide with Merck Serono, worth up to $ 200 million plus royalties
  • Start of pivotal Phase III trial with safinamide in mid to late-stage Parkinson’s disease patients
  • Newron's IPO on the SWX Swiss Exchange raises €74.3 million – one of the top 3 global biotech IPOs of 2006

 

2005

  •  Newron raises  €30 million C round , new entries HBM and TVM

 

2004 

  • Newron initiates Parkinson's disease Phase III trial with safinamide
  • Newron and Zambon Group sign collaboration to develop novel treatments for pain conditions
  • EU Ion channel project grant (€1.2m)

 

2003

  • Newron receives US IND approval for safinamide in Parkinson's disease

 

2002/3 

  • Newron closes B funding (€25 million), with Atlas and Apax Partners joining
  • Italian government grant (€2.2m)

 

2001 

  • Completion of A funding by 3i (€7.3m)
  • Italian government grant (€6.2m)

 

2000

  •  Biosearch Italia and Newron enter into collaboration program for the discovery of new drugs for CNS disorders

 

1999

  • Newron established;  acquisition of assets from Pharmacia & Upjohn (“Pharmacia Italy”)