RTTNews | Jun 29, 2021 10:57AM EDT

10:57 Tuesday, June 29, 2021 (RTTNews.com) - MediWound Ltd. (MDWD) shares are down 28 percent on Tuesday morning trade after U.S. Food and Drug Administration said it determined that the biologics license application or BLA for NexoBrid cannot be approved in the present form.

In the complete response letter, FDA said it has identified issues related to the Chemistry, Manufacturing, and Controls or CMC section of the BLA and requested additional CMC information. The FDA also wants to inspect NexoBrid's manufacturing facilities in Israel and Taiwan prior to BLA approval.

The integrated biopharmaceutical company's NexoBrid was for eschar removal or debridement in adults with deep partial-thickness and or full thickness of thermal burns.

Currently, shares are at $4.03, down 28.43 percent from the previous close of 5.64 on a volume of 3,016,335. For the 52-week period, the shares have traded in a range of $2.71-$6.22 on average volume of 209,876.

Read the original article on RTTNews ( https://www.rttnews.com/3205787/mediwound-down-29-after-fda-determines-not-to-approve-bla-for-nexobrid.aspx)

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