Biotech Values

[DewDiligence]

ADVM phase-1 in AMD on FDA clinical hold re CMC issues:

https://www.globenewswire.com/news-release/2019/04/15/1804030/0/en/Adverum-Biotechnologies-Provides-Clinical-Program-Update-on-ADVM-022-Gene-Therapy-for-Wet-AMD.html

Adverum has received a notification from the U.S. Food and Drug Administration (FDA) in early April requesting additional CMC information and requirements on the ADVM-022 manufacturing process. The FDA has placed the Company’s IND on clinical hold until the agency has reviewed Adverum’s response, which was submitted last week. The Company is working closely with the agency during its review. The Company expects to resume dosing of patients once the FDA review is completed and the clinical hold is lifted.