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Wednesday, October 30, 2019

Novartis Announces Avxs-101 Intrathecal Study Update

-- FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA 
      patients based on findings in a small pre-clinical animal study 
 
   -- Adverse events that might be expected from the pre-clinical findings have 
      not been seen in a thorough review of human safety data from all 
      available sources to date 
 
   -- Zolgensma(R) (onasemnogene abeparvovec-xioi) also known as AVXS-101 
      intravenous administration is not impacted and remains available in the 
      US 
 
   -- Novartis is working with FDA to determine next steps to release partial 
      hold and resume dosing in the AVXS-101 intrathecal trials 
https://www.marketscreener.com/NOVARTIS-9364983/news/NOVARTIS-CHF0-50-REGD-Novartis-Announces-Avxs-101-Intrathecal-Study-Update-29479214/

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