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If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU
ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks
Recommendation is based on results from the two pivotal Phase III
SAkuraStar
SAkuraSky studies, in which ENSPRYNG demonstrated robust and sustained efficacy in reducing the risk of relapse and a
favourable safety profile
NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system that can cause blindness, muscle weakness and paralysis
Investegate |F Hoffmann-La Roche Ltd Announcements | F Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)
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F Hoffmann-La Roche Ltd: Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
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Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
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Basel, 22 April 2021 - Roche ((SIX: RO, ROG, OTCQX:RHHBY) and GenMark Diagnostics, Inc. today announced that Roche s wholly owned subsidiary Geronimo Acquisition Corp. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of GenMark Diagnostics, Inc. (NASDAQ:GNMK) at a price of USD 24.05 per share in cash. The tender offer expired at 12:00 midnight, Eastern Time, at the end of the day on 21 April 2021 and was not extended.
Roche has been advised by Citibank, N.A., the depositary for the tender offer, that a total of approximately 61,201,761 shares of GenMark s common stock were validly tendered and not validly withdrawn in the tender offer (excluding shares tendered by notice of guaranteed delivery for which certificates have not yet been received ), which represent approximately 82.89% of the total number of shares of GenMark s common stock outstanding.