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MDWD

MediWound

$5.50

0.355 (6.90%)

07:10
03/25/19
03/25
07:10
03/25/19
07:10

MediWound plans to file BLA for NexoBrid in 2H19

"2018 was a pivotal year for MediWound as we made significant progress on several fronts. On the development side, after completing enrollment in our Phase 3 DETECT study of NexoBrid last summer, we announced in January 2019 that we met the primary and all secondary endpoints with statistically significant results compared with the control group," said Gal Cohen, MediWound's President and CEO. "These excellent top-line results corroborated our previous positive European Phase 3 clinical study results and further demonstrate how meaningfully NexoBrid can impact patients' lives. We plan to file the BLA in the second half of 2019, subject to FDA concurrence in a pre BLA meeting planned for the second quarter of 2019. In addition, we expanded our NexoBrid Phase 3 CIDS study in children, to U.S. burn centers after receiving FDA concurrence on the protocol and BARDA funding for the study. For EscharEx, as requested by the FDA, we submitted information on the additional suggested secondary efficacy endpoints, and subject to FDA agreement, plan to advance the EscharEx clinical development program in the first half of 2019."

  • 25

    Mar

MDWD MediWound
$5.50

0.355 (6.90%)

08/08/18
WELS
08/08/18
NO CHANGE
Target $11
WELS
Outperform
MediWound could be sold for 'substantially higher price,' says Wells Fargo
Wells Fargo analyst David Maris noted that MediWound's Chairman said on the company's earnings call that while the board previously thought it would have more clarity by its Q2 report on its previously disclosed consideration of a potential strategic transaction, the company is taking a "comprehensive and measured approach" as it is still in talks with several parties. If MediWound is able to conclude a strategic combination, it would be for "a substantially higher price" and one that contemplates cash flows beyond Maris' current assumptions, he stated. Maris keeps an Outperform rating and $11 price target on MediWound shares.
09/25/18
WELS
09/25/18
NO CHANGE
Target $11
WELS
Outperform
MediWound BARDA contract 'highly value-creating,' says Wells Fargo
Wells Fargo analyst David Maris estimates MediWound's new BARDA contract to develop NexoBrid for the treatment of Sulfur Mustard injuries should be worth approximately $1 per share. The analyst views the deal as an "endorsement of the promise" of NexoBrid and the potential for longer-term government contracts if approved. He currently does not model NexoBrid government sales but believes the size of the mass casualty preparedness market could rival the burn market. Overall, the contract from the U.S. Biomedical Advanced Research and Development Authority is a "highly value-creating deal," Maris tells investors in a research note. He keeps an Outperform rating on MediWound with an $11 price target.
03/12/19
RHCO
03/12/19
NO CHANGE
Target $9
RHCO
Buy
MediWound may be near strategic deal, says SunTrust
After MediWound announced that CEO Gal Cohen has decided to step down, SunTrust analyst Bruce Nudell said he believes the fact that Cohen is pursuing another opportunity while retaining his share interest in MediWound, along with the lack of formal search for a successor, is "consistent with the notion that a strategic deal is near in hand." Nudell has a Buy rating and $9 price target on MediWound shares.
03/12/19
WELS
03/12/19
NO CHANGE
Target $11
WELS
Outperform
MediWound CEO change 'occurred from a position of strength,' says Wells Fargo
After speaking to management, Wells Fargo analyst David Maris believes the CEO change at MediWound "appears to have occurred from a position of strength" after the recently announced positive Phase III data for NexoBrid and advancing strategic discussions. The analyst continues to think the company will be able to "unlock sizable value" with a strategic transaction or partnership. Further, Maris expects MediWound "will not miss a step" transitioning to new CEO Sharon Malka. He maintains an Outperform rating on the shares with an $11 price target.

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