Milestones

2003

  • Auris Medical founded
  • License agreement with Xigen
  • Collaboration agreement with Inserm

2004

  • Launch of R&D operations in Montpellier, France

2005

  • EMA grants Orphan Drug Designation for AM-111

2006

  • FDA grants Orphan Drug Designation for AM-111
  • Phase I/II clinical trial with AM-111

2007

  • Start of Phase I/II clinical trial with AM-101
  • Series B financing round

2008

  • Move to Basel, Switzerland
  • Completion of Phase I/II clinical trial with AM-101

2009

  • Start of first Phase II clinical trial with AM-101 (TACTT0)
  • Start of Phase II clinical trial with AM-111

2010

  • IND open for AM-101

2011

  • TACTT0 trial with AM-101 completed – proof of concept demonstrated
  • Start of second Phase II trial with AM-101 (TACTT1)

2012

  • Phase II trial with AM-111 completed – proof of concept demonstrated

2013

  • Series C financing round
  • TACTT1 completed
  • Special Protocol Assessment (SPA) with FDA for AM-101 Phase III trial
  • AM-102 target validation

2014

  • Start of Phase III trial with AM-101 (TACTT2, TACTT3)
  • Initial public offering of shares and listing on Nasdaq

2015

  • Interim analysis in TACTT3 stratum suggesting activity of AM-101 beyond acute tinnitus stage 
  • Follow-on public offering of shares
  • Start of Phase III trial with AM-111 in Europe and Asia (HEALOS)

2016

  • Introduction of Keyzilen® as brand name for AM-101
  • Start of Phase III trial with AM-111 in US, Canada and South Korea (ASSENT)
  • FDA grants fast track designation for Keyzilen® (AM-101)
  • TACTT2 completed

2017

  • Added AM-125 to clinical development pipeline
  • Follow-on public offering of shares
  • FDA grants fast track designation for AM-111