Santhera Plans to Announce Regulatory Feedback for Raxone® in DMD and 2017 Preliminary Key Financial Figures
Santhera Pharmaceuticals Holding AG / Santhera Plans to Announce Regulatory Feedback for Raxone® in DMD and 2017 Preliminary Key Financial Figures . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.
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Liestal, Switzerland, January 19, 2018 - Santhera Pharmaceuticals (SIX: SANN) expects to announce feedback from the CHMP on its Marketing Authorization Application (MAA) for Raxone® in Duchenne muscular dystrophy (DMD) on January 26, 2018, and will publish the Company's preliminary key financial figures for 2017 on January 29, 2018.
Announcement of CHMP opinion on MAA for Raxone® in DMD expected for January 26, 2018
Santhera expects to receive an opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its MAA filed as Type II extension application for
Raxone® (idebenone) in DMD by January 26, following a re-examination procedure. Santhera expects to announce the CHMP opinion on January 26, 2018, at 07:00 hrs CET. On the same day,
at 14:00 hrs CET, Thomas Meier, PhD, CEO of Santhera, will hold an investor conference call to discuss the outcome.
Announcement of 2017 Key Financials on January 29, 2018
Santhera will release its preliminary key financial figures for 2017 and provide a corporate update on January 29, 2018, at 07:00 hrs CET. In an investor conference call scheduled the
same day at 14:00 hrs CET, Thomas Meier, PhD, CEO of Santhera, will discuss the key financials and the development of the business.
The 2017 Annual Report with full financial results will be published on March 20, 2018, at 07:00 hrs CET.
Access to conference calls
Participants can access either conference call by dialing one of the following numbers about 10 minutes before the call is due to start:
+41 (0)58 310 50 00 (Europe)
+44 (0)207 107 0613 (UK)
+1 (1)631 570 5613 (USA)
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of
innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases. Santhera's lead product Raxone® (idebenone) is authorized in the European Union, Norway,
Iceland, Liechtenstein and Israel for the treatment of Leber's hereditary optic neuropathy (LHON). For Duchenne muscular dystrophy (DMD), Santhera has filed a Marketing Authorization Application in
the European Union and Switzerland for DMD patients with respiratory function decline who are not taking glucocorticoids. In collaboration with the U.S. National Institute of Neurological Disorders
and Stroke (NINDS) Santhera is developing Raxone® in a third indication, primary progressive multiple sclerosis (PPMS), and another product - omigapil - for congenital muscular dystrophy (CMD),
both also areas of high unmet medical need. For further information, please visit the Company's website www.santhera.com.