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MediWound Ltd. (MDWD)

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3.7538+0.0438 (+1.18%)
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Neutralpattern detected
Previous Close3.6600
Open3.6400
Bid3.7500 x 800
Ask3.8000 x 1800
Day's Range3.6211 - 3.8000
52 Week Range1.4430 - 4.4400
Volume31,431
Avg. Volume135,382
Market Cap102.145M
Beta (5Y Monthly)1.63
PE Ratio (TTM)N/A
EPS (TTM)-0.3390
Earnings DateAug 06, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est7.08
  • GlobeNewswire

    MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns

    YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “MediWound”), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. “The FDA’s acceptance of the NexoBrid BLA submission for review is a major milestone for MediWound, and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States,” said Sharon Malka, CEO of MediWound. “We thank all our partners for their commitment to this important program, and we look forward, together with BARDA and Vericel, to working with the FDA during the regulatory review process as we seek marketing approval for NexoBrid in the United States.”Nick Colangelo, President and CEO of Vericel, added, “The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns and brings us one step closer to providing NexoBrid as a treatment option for the thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement.”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/or 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 biologic drug in the United States, European Union and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation (NASDAQ: VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).Vericel, our U.S. commercial partner, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid, which will include discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.About NexoBrid NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment.About MediWound MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound’s second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.About BARDA The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA.Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.Cautionary Note Regarding Forward-Looking Statements MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.Contacts: Boaz Gur-Lavie Chief Financial Officer MediWound Ltd. ir@mediwound.com                         Jeremy Feffer Managing Director, LifeSci Advisors 212-915-2568 jeremy@lifesciadvisors.com

  • Oppenheimer: 3 Stocks That Could Surge Over 100% From Current Levels
    TipRanks

    Oppenheimer: 3 Stocks That Could Surge Over 100% From Current Levels

    So far, September has been a wild ride of ups and downs. Following the recent bout of volatility, stocks have ticked higher again. But as uncertainty regarding another rescue program and the presidential election continues to linger, where does the market go from here? Weighing in for Oppenheimer, Chief Investment Strategist John Stoltzfus argues that any market dips appear “relatively contained and orderly,” and present longer-term investors the chance to find “babies that got thrown out with the bathwater.” He noted, “For nervous investors the recent downdraft has presented opportunity to take some profits without FOMO (fear of missing out).”As for the tech heavyweights that powered the market’s five-month charge forward, the strategist believes “current expectations that technology stocks will remain under pressure for some time seem exaggerated.” Stoltzfus adds that the “core of technology stocks did not appear terribly rich in price considering that developments in technology and innovation have yet to show signs of plateauing in the current cycle.”Taking Stoltzfus’ outlook into consideration, our focus turned to stocks that Oppenheimer analysts are bullish on. The firm's pros see triple-digit upside potential in store for three tickers in particular. Running the names through TipRanks’ database, we wanted to find out what makes each so compelling.MediWound Ltd. (MDWD)Developing cutting-edge products, MediWound wants to address unmet needs in the fields of severe burn and chronic wound management. With an important government contract secured, Oppenheimer has high hopes for this name.Back in January, MDWD announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) had entered into a contract to procure $16.5 million of NexoBrid, its drug designed to remove eschar in adults with deep partial and full-thickness thermal burns (a process called debridement), for an emergency stockpile. According to management, the first delivery is set for Q3 2020.On top of this, the company filed the NexoBrid Biologics License Application (BLA) with the FDA for eschar removal in adults with deep partial-thickness and full-thickness thermal burns in June. MDWD’s U.S. commercial partner, Vericel, is preparing for an immediate launch upon approval.Representing Oppenheimer, 5-star analyst Kevin DeGeeter points out that “Given the filing involved participation from three parties—MDWD, U.S. commercial partner Vericel and funding partners at BARDA—and was completed against the backdrop of public sector work-from-home mandates, we view meeting stated timelines as a material milestone and derisking event for MDWD shares... we believe NexoBrid is on track for 1H21 launch.”Should the therapy ultimately be approved, MDWD is entitled to a $7.5 million milestone payment from Vericel. “We believe the combination of existing cash and the $7.5 million milestone payment from VCEL upon NexoBrid approval should fund operations at least into 2H23,” DeGeeter added.DeGeeter also points out that MDWD plans to open 25-30 sites in U.S. and Israel to support the Phase 2 study of EscharEx, its product for chronic wounds. Although COVID-19 resulted in a delay, the analyst thinks “the current timeline of 1H21 is achievable.”To this end, DeGeeter rates MDWD an Outperform along with a $7 price target. Should his thesis play out, a potential twelve-month gain of 117% could be in the cards. (To watch DeGeeter’s track record, click here)All in all, other analysts echo DeGeeter’s sentiment. 4 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $6.63, the upside potential comes in at 106%. (See MDWD stock analysis on TipRanks)UroGen Pharma (URGN)Primarily focused on uro-oncology, UroGen Pharma develops advanced non-surgical treatments to improve the lives of patients. As the launch of one of its products is progressing well, Oppenheimer thinks that now is the time to get on board.Writing for the firm, analyst Leland Gershell points to UGN-101 as a key component of his bullish thesis. UGN-101, which has now been formally launched in the U.S. under the commercial name Jelmyto, was designed as a treatment for low-grade upper tract urothelial carcinoma (LG UTUC). The analyst highlights that Jelmyto’s launch is already off to a solid start, as eight patients had received 20 doses of the drug in June.“Jelmyto sales were $371,000 in its first month of launch, but more important was management's commentary that over 100 urology practice sites are treatment-ready for the product, and that patient demand has not been visibly impacted by COVID-19,” Gershell explained.Adding to the good news, permanent C- and J-codes, which are expected in October and January 2021, respectively, could bolster sales, in Gershell’s opinion. The label could also be updated to reflect completed OLYMPUS data.It should be noted that patient and physician engagement could remain diminished through YE20, and restrictions around elective surgeries could persist, according to Gershell. That said, he argues that “LG UTUC's lack of surgical urgency could imply treatment deferral for several months, whereas Jelmyto's ability to be administered in an outpatient setting could expedite treatment, favoring adoption.”If that wasn’t enough, UGN-102, its mitomycin gel that targets low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC), is set to enter pivotal testing before the end of 2020. Looking at previously released data, the therapy achieved a 65% complete response (CR) rate at three months following onset of treatment. “To offset any potential COVID-19 impact on enrollment, URGN has increased the number of clinical trial sites outside of the U.S., in those countries where virus-related clinical delays have not cropped up,”Gershell added.Summing it all up, Gershell commented, “We believe shares trade at a discount to the value of Jelmyto and UGN-102, and that revenue growth will support stock upside over the next 12 months.”To this end, Gershell stands with the bulls, reiterating an Outperform rating. At $48, his price target brings the upside potential to 123%. (To watch Gershell’s track record, click here)What does the rest of the Street have to say? 3 Buy ratings and 1 Hold have been issued in the last three months. As a result, URGN receives a Strong Buy consensus rating. In addition, the $44 average price target suggests 104% upside potential. (See URGN stock analysis on TipRanks)Ayala Pharmaceuticals Inc. (AYLA)Last but not least we have Ayala Pharmaceuticals, which is focused on developing targeted therapies for cancers in which Notch activation is a known tumor driver. Based on the progress across its development pipeline, Oppenheimer sees big gains in store.Oppenheimer analyst Jay Olson thinks AYLA’s technology makes it a stand-out. Its two candidates, AL101 and AL102, which are in-licensed from Bristol Myers, are gamma-secretase inhibitors that target aberrant activation of Notch signaling in cancer cells.Notch signaling plays an important role in normal cell development, and perturbations can cause malignant transformation. “We believe Notch targeted therapies hold promise in addressing unmet clinical needs,” Olson commented.The analyst added, “The Notch mutational landscape is diverse, and the underlying science is evolving. AYLA is building a bioinformatics database around Notch to better characterize and identify Notch-activating mutations. Additionally, AYLA is collaborating with partners developing diagnostic tests for Notch-activating mutations, both at DNA and RNA levels. We believe these initiatives benefit AYLA in the long term by identifying responders and expanding the addressable patient population.”Despite the challenges presented by COVID-19, critical catalysts remain on track. The company is set to present new interim data from the Phase 2 ACCURACY open-label study of AL101 in R/M ACC at the mini oral head and neck cancer section of ESMO. Looking at the available data, a recent interim analysis in one cohort showed 69% DCR.As for the second cohort, it is evaluating a 6mg once-weekly dosing of AL101. “We view the efficacy and safety data from the 6mg dosing cohort as important for the registration-enabling studies, and we anticipate similar interim data readout in 1H21,” Olson said.Adding to the good news, AYLA is on track to kick off patient dosing in the Phase 2 TENACITY study of AL101 in R/M TNBC by YE20 after the IND was cleared by the FDA in April. In 2021, AYLA plans to initiate two additional Phase 2 studies including AL102 for desmoid tumors and AL101 for r/r T-ALL.“Springworks Therapeutics recently announced the completion of patient enrollment of the Phase 3 DeFi trial of nirogacestat in desmoid tumors with topline data expected mid-2021, which should provide read-across to AYLA's AL102 program,” Olson noted.Given all of the above, Olson opined, “We're encouraged by AYLA's advantages along several dimensions, including its drug candidates, cancer indication selection, and focus on identifying Notch-activating mutations while developing diagnostics. AYLA's Notch targeted approach should address unmet clinical needs for patients with rare but aggressive cancers.”It should come as no surprise, then, that Olson stayed with the bulls. To this end, he kept an Outperform rating and $23 price target on the stock, implying 123% upside potential. (To watch Olson’s track record, click here)Looking at the consensus breakdown, 2 Buys and 1 Hold have been published in the last three months. Therefore, AYLA gets a Moderate Buy consensus rating. Based on the $19.83 average price target, shares could climb 92% higher in the next year. (See AYLA stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.