Your email has been successfully added to our mailing list.

×
0.0636704119850187 0.0636704119850187 0.0636704119850187 0.127340823970038 0.198501872659176 0.123595505617978 0.123595505617978 0.052434456928839
Stock impact report

MediWound Announces Submission of Biologics License Application to the U.S. FDA for NexoBrid for the Treatment of Severe Thermal Burns

MediWound Ltd (MDWD)  More Company Research Source: GlobeNewswire
Last mediwound ltd earnings: 2/25 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: ir.mediwound.com/press-releases
PDF YAVNE, Israel, June 30, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan [Read more]
Impact snapshot Event time: MDWD
Last Price
Price Change
Price Change %
Volume Shares
Max Up
Max Down
Volume Ratio
%
Performance comparison Updated
Event Day
Stock performance from the time of news release until the following 4pm ET market close
Last price at news event
Since Event
Multi-day stock performance from the time of the news release
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST
PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
Last price
VWAP
High:
Max up
High:
Low:
Max down
Low:
%
Post news range
%
Price change

Price Change Percentage


S&P 500
(SPX)

%

Volume ratio
%

Volume
Ticks

Avg transaction size

Opt-in for
MDWD alerts

from News Quantified
Opt-in for
MDWD alerts

from News Quantified