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Fly News Breaks for February 6, 2019
Feb 6, 2019 | 09:07 EDT
CytRx reported positive Phase 2/3 clinical trial data from arimoclomol licensee Orphazyme A/S. Orphazyme is currently developing arimoclomol in four different indications. In the full data set for its Phase 2/3 trial evaluating arimoclomol in patients with Niemann-Pick disease Type C, the primary endpoint showed a 74% reduction in disease progression after 12 months compared to placebo control. Biomarker results demonstrated statistically significant biological response to treatment. Orphazyme will initiate filing preparations and seek to meet with the FDA and EMA mid-2019 to discuss the path to approval. Orphazyme plans to submit the regulatory filing to the FDA and EMA during 1H20, with potential approval expected during 2H20. If arimoclomol is approved for NPC in the U.S. and Europe, CytRx is eligible to receive $10M in milestone payments, plus royalties. CytRx is eligible to receive up to $120M in future milestones, plus royalties, from the arimoclomol licensing agreement.
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