MediWound down on FDA action, but Wall St sees eventual approval of burn treatment

Vericel

30/06/2021 12:21

** Shares of Israel-based MediWound Ltd  MDWD.O  down 5.4%
at $3.85 premarket, after closing down 27.8% on Tuesday
    ** The FDA declines to accept MDWD's lead burn treatment,
NexoBrid, citing issues related to the chemistry, manufacturing
and controls (CMC) section of the application  urn:newsml:reuters.com:*:nL3N2OB2ZW
    ** Also calls for inspection at co's manufacturing
facilities in Taiwan and Israel before potential approval
    ** Brokerage BTIG lowers PT on MDWD to $5 from $7 and from
$63 to $62 for its partner Vericel Corp  VCEL.O 
    ** However, brokerage believes only the timing of the
treatment's approval has been impacted and expects NexoBrid to
be in the market in H2 2022
    ** Cowen does not believe the integrity of the treatment's
Phase III data is at risk and expects a mid-2022 approval; cuts
PT on MDWD from $7 to $6
    ** H.C. Wainwright says threat to the treatment's eventual
approval is unlikely, but adds it is difficult to predict the
timing of the needed inspections by the FDA given that the
pandemic has not been completely controlled in Taiwan
    ** MDWD had gained 10% YTD, up to the last close

 (Reporting by Amruta Khandekar)
 ((Amruta.Khandekar@thomsonreuters.com;))