View Financial HealthMediWound 배당 및 자사주 매입배당 기준 점검 0/6MediWound 배당금을 지급한 기록이 없습니다.핵심 정보n/a배당 수익률-14.5%자사주 매입 수익률총 주주 수익률-14.5%미래 배당 수익률n/a배당 성장률n/a다음 배당 지급일n/a배당락일n/a주당 배당금n/a배당 성향n/a최근 배당 및 자사주 매입 업데이트업데이트 없음모든 업데이트 보기Recent updates공시 • May 07MediWound Ltd. to Report Q1, 2026 Results on May 27, 2026MediWound Ltd. announced that they will report Q1, 2026 results Pre-Market on May 27, 2026공시 • Apr 08Mediwound Ltd. Presents New Escharex Data At Wound Care ConferencesMediWound Ltd. announced multiple oral and poster presentations at three wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2026, taking place April 8–12 in Charlotte, North Carolina, and the European Wound Management Association (EWMA) 2026, taking place May 6–8 in Bremen, Germany. The presentations will showcase new preclinical and clinical data supporting EscharEx’s differentiated mechanism of action, clinical performance, and advancement of its ongoing Phase III development in venous leg ulcers (VLUs), as well as its planned expansion into diabetic foot ulcers (DFUs) and pressure ulcers. A new preclinical mechanistic study demonstrated superior debridement with EscharEx versus SANTYL across multiple non-viable tissue components, while gene expression analysis revealed that EscharEx specifically activates molecular pathways that support wound healing. New analysis demonstrating improved long-term scar outcomes following enzymatic debridement compared to surgical and non-surgical standard of care. New data on time to wound closure following autograft or placental-derived allografts in VLUs, supporting the statistical assumptions of the ongoing VALUE Phase III study. Post-hoc analysis from the ChronEx Phase II multicenter randomized controlled trial highlighting that adequate wound bed preparation is a prerequisite for wound closure, supporting the co-primary endpoint of the VALUE Phase III study. Scientific session highlighting the expanding role of bromelain-based enzymatic therapy from acute burn care to chronic wound management, including clinical case studies, comparison to SANTYL, Phase III VALUE trial updates in VLUs, and future development in DFUs and pressure injuries. Post-hoc analysis demonstrates the efficacy of bromelain-based enzymatic debridement in DFUs, supporting ongoing development in this indication. Additional analyses from the ChronEx Phase II randomized controlled trial, further strengthening the clinical foundation for the ongoing VALUE Phase III study. EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLUs) is underway, with clinical studies in diabetic foot ulcers (DFUs) and pressure ulcers (PUs) planned for H2 2026. EscharEx has demonstrated advantages over the leading enzymatic debridement agent and targets a substantial global market opportunity.공시 • Apr 01MediWound Ltd., Annual General Meeting, May 06, 2026MediWound Ltd., Annual General Meeting, May 06, 2026. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york,10020-1300., new york, United States공시 • Mar 05Mediwound Ltd. Reaffirms Revenue Guidance for the Year 2026, 2027 and 2028MediWound Ltd. reaffirmed its revenue guidance for the year 2026, 2027 and 2028. For the year 2026, the company expect revenue of $24–26 million. For the year 2027, the company expect revenue of $32–35 million. For the year 2028, the company expect revenue of $50–55 million.공시 • Feb 19MediWound Ltd. to Report Q4, 2025 Results on Mar 05, 2026MediWound Ltd. announced that they will report Q4, 2025 results on Mar 05, 2026분석 기사 • Jan 14We Think MediWound (NASDAQ:MDWD) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, although...공시 • Jan 13Mediwound Ltd. Updates Revenue Guidance for the Fiscal Year 2026 , 2027, and 2028MediWound Ltd. updated revenue guidance for the fiscal year 2026, 2027, and 2028. For the 2026, Updated revenue guidance projects $24–26 million. For the 2027, updated revenue guidance projects $32–35 million. For the 2028, updated revenue guidance projects $50–55 million.공시 • Dec 11MediWound Ltd. Reports New Clinical Data Demonstrating NexoBrid's Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast InjuriesMediWound Ltd. announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid®? substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries. Traumatic tattoos occur when high-velocity accidents or blasts drive materials such as asphalt, dirt, glass, or metallic particles (shrapnel) into the skin, often leaving not only permanent dark discoloration but also causing aesthetic deformities, functional impairment, and increased risk of inflammation or infection. Current standard of care relies on aggressive non-selective mechanical scrubbing, which may leave embedded particles behind and may risk damage to viable tissue. NexoBrid development has been supported with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C.분석 기사 • Nov 23The MediWound Ltd. (NASDAQ:MDWD) Third-Quarter Results Are Out And Analysts Have Published New ForecastsLast week, you might have seen that MediWound Ltd. ( NASDAQ:MDWD ) released its third-quarter result to the market. The...공시 • Nov 05MediWound Ltd. to Report Q3, 2025 Results on Nov 20, 2025MediWound Ltd. announced that they will report Q3, 2025 results on Nov 20, 2025분석 기사 • Oct 16Getting In Cheap On MediWound Ltd. (NASDAQ:MDWD) Might Be DifficultYou may think that with a price-to-sales (or "P/S") ratio of 12.6x MediWound Ltd. ( NASDAQ:MDWD ) is a stock to avoid...공시 • Sep 30MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million.MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,734,105 Price\Range: $17.3 Discount Per Security: $1 Transaction Features: Registered Direct Offering공시 • Sep 25Mediwound Ltd. Expands Global Reach with Marketing Approval of Nexobrid®? in AustraliaMediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®?, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns. With this approval, NexoBrid is now authorized in 45 countries worldwide, reflecting its growing recognition as a new standard of care in burn management. MediWound's exclusive partner in Australia, Balance Medical, expects to initiate commercial launch in the fourth quarter of 2025. MediWound's manufacturing expansion, on track for completion by year-end 2025, will support this launch and future global demand.Seeking Alpha • Sep 02MediWound Is A Buy Opportunity On The DipSummary MediWound is a niche biotech with strong R&D, FDA-approved products, and a promising pipeline, but remains underfollowed and volatile. Despite weak current performance and negative metrics, the company has a solid cash runway, no debt, and recent strategic investments. NexoBrid's expanded approvals and rising hospital orders, plus a new facility, position MediWound for significant revenue growth in burn care. The stock is a high-risk, high-reward buy opportunity with potential for future takeovers and strong upside if commercialization succeeds. Read the full article on Seeking Alpha공시 • Aug 14Mediwound Ltd. Announces New Escharex Phase Ii Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg UlcersMediWound Ltd. announced the publication of "The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the enzymatic therapies for non-surgical tissue repair, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue. Key Findings: Wounds that failed to achieve WBP had a 90% probability of not healing (Negative Predictive Value = 90%) Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004); Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005); Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001). These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx's therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers. Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: "While wound bed preparation has long been accepted as the concept foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation.공시 • Aug 04MediWound Ltd. to Report Q2, 2025 Results on Aug 14, 2025MediWound Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 14, 2025공시 • May 21MediWound Ltd. Reaffirms Revenue Guidance for the Year 2025MediWound Ltd. reaffirmed revenue guidance for the year 2025. For the full-year 2025 revenue guidance reaffirmed at $24 million.분석 기사 • May 14We Think MediWound (NASDAQ:MDWD) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...공시 • May 14MediWound Ltd. Announces Publication of Phase II EscharEx® Data Demonstrating Superiority over Collagenase in Venous Leg UlcersMediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company's Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx®? compared with Collagenase ointment (SANTYL®?), the only FDA-cleared enzymatic debridement agent commercially available for the treatment of dermal ulcers. The article, titled "Bromelain-Based Debridement Versus Collagenase Ointment Debridement Debridement Debridement of Venous Leg Ulcers: Post Hoc Analysis of the ChronEx Trial," appears in the April 2025 edition of Wounds (Index 2025;37(4):166-173) and compares outcomes in a subgroup of patients from the non-surgical standard of care arm treated with SANTYL (n=8) to those treated with EscharEx (n=46). EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.공시 • May 05MediWound Ltd. to Report Q1, 2025 Results on May 21, 2025MediWound Ltd. announced that they will report Q1, 2025 results on May 21, 2025공시 • Apr 28MediWound Ltd. to Present New EscharEx®? Data At Leading Wound Care ConferencesMediWound Ltd. announced that it will present 10 scientific abstracts--including both oral and poster presentations-- at two of the world's premier wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, taking place April 30-May 3 in Grapevine, Texas. The presentations will feature new preclinical and clinical data on EscharEx®?, MediWound's investigational enzymatic therapy for chronic wounds. The findings offer important insights into EscharEx's multitargeted and selective proteolytic activity on non-viable tissue. Results from a novel hard-to-heal wound model demonstrating EscharEx's superior debridement efficacy compared to collagenase SANTYL®? Symposium on Advanced Wound care (SAWC). Overview of EscharEx's mechanism of action, including in vitro studies and clinical findings from EscharEx and NexoBrid®? Case studies highlighting EscharEx's use in advanced DFUs (Wagner grade 2) and VLUs. Post-hoc analyses in DFUs and preliminary strategy for the planned clinical trial. Update on the VALUE Phase III study design and enrollment progress. The VALUE Phase III study is currently enrolling patients with VLUs across multiple sites, building on positive results from three completed Phase II studies that demonstrated EscharEx's efficacy, safety, and potential to enhance standard wound care practices.분석 기사 • Apr 18What You Can Learn From MediWound Ltd.'s (NASDAQ:MDWD) P/SWith a price-to-sales (or "P/S") ratio of 9.1x MediWound Ltd. ( NASDAQ:MDWD ) may be sending very bearish signals at...공시 • Apr 08MediWound Ltd., Annual General Meeting, May 15, 2025MediWound Ltd., Annual General Meeting, May 15, 2025. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, 10020-1300., new york United States새로운 내러티브 • Apr 02FDA Approval And Phase III Trial Will Expand Wound Care Strong EscharEx results and strategic partnerships boost potential sales growth, leveraging Medicare policies and Phase III trials for greater revenue prospects. 공시 • Mar 03MediWound Ltd. to Report Q4, 2024 Results on Mar 19, 2025MediWound Ltd. announced that they will report Q4, 2024 results on Mar 19, 2025공시 • Feb 26MediWound Ltd. Announces Phase III CIDS Publication on NexoBrid for Pediatric Burn CareMediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI). The study evaluated the efficacy and safety of NexoBrid®? compared to the standard of care (SOC) in pediatric patients with deep partial- and full-thickness thermal burns. The publication, titled "Open-Label RCT of the Efficacy and Safety of NexoBrid Compared to SOC in Children with Burns," presents findings that supported the label expansion of NexoBrid for pediatric patients in the E.U. (2023) and U.S. (2024). These results reinforce NexoBrid's clinical benefits as a rapid, effective, and non-surgical alternative for eschar removal in pediatric burn patients, validating its significance as a transformative treatment in burn care. Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burn, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx®?, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the currently available $375+ million drug for wound debridement, presenting a unique opportunity for significant market growth.공시 • Feb 12MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg UlcersMediWound Ltd. announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the U.S. and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over two weeks, followed by ten weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks. The study co-primary endpoints are the incidence of complete debridement and the incidence of complete wound closure. Secondary endpoints include the incidence of complete granulation tissue, time to debridement, time to complete wound closure, and changes in wound area. Safety and tolerability of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026. To support the trial, MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes. In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025, comparing EscharEx to collagenase in VLU patients. This Phase II trial is designed to support the U.S. Biologics License Application (BLA) submission for EscharEx and strengthen MediWound’s commercialization strategy. Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026.분석 기사 • Feb 12Is MediWound (NASDAQ:MDWD) In A Good Position To Invest In Growth?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...분석 기사 • Jan 09MediWound Ltd.'s (NASDAQ:MDWD) P/S Still Appears To Be ReasonableWhen you see that almost half of the companies in the Pharmaceuticals industry in the United States have price-to-sales...분석 기사 • Nov 29Earnings Update: MediWound Ltd. (NASDAQ:MDWD) Just Reported And Analysts Are Trimming Their ForecastsMediWound Ltd. ( NASDAQ:MDWD ) just released its latest quarterly report and things are not looking great. It was not a...공시 • Nov 26MediWound Ltd. Revises Revenue Guidance for 2024MediWound Ltd. revised revenue guidance for 2024. The Company anticipates $20 million in total revenue for 2024, compared to prior guidance of $24 million.공시 • Nov 12MediWound Ltd. to Report Q3, 2024 Results on Nov 26, 2024MediWound Ltd. announced that they will report Q3, 2024 results on Nov 26, 2024Seeking Alpha • Oct 29MediWound Is A Healthy InvestmentSummary MediWound is a long-term buy opportunity with significant upside potential, driven by its innovative wound and lesion care products in a strong, growing industry. Despite current financial struggles, including increased losses and low margins, MediWound's revenue is expected to grow, and it garners support from government and industry investments. MDWD has shown strong momentum, nearly doubling in price YTD, and is backed by a healthy mix of institutional and private investors. Retail value investors with patience and unneeded cash can safely accumulate MediWound stock, anticipating positive growth and a brighter 2025 revenue outlook. Read the full article on Seeking Alpha공시 • Oct 10MediWound Ltd. Announces Phase II Head-To-Head Study Evaluating EscharEx®? vs. Collagenase in Patients with Venous Leg UlcersMediWound Ltd. announced that it will be initiating a controlled, multicenter Phase II clinical study evaluating EscharEx® against collagenase ointment (marketed as SANTYL® in the U.S. and IRUXOL® in Europe) for the treatment of venous leg ulcers (VLUs). Scheduled to commence in 2025, this Phase II study will run concurrently with the Company’s Phase III trial in VLU patients. The study is designed to support the Biologics License Application (BLA) for EscharEx and plays a key role in MediWound’s commercialization strategy. The randomized, prospective study will enroll 45 patients across multiple sites in the U.S. and Europe. VLU patients will be randomly assigned in a 1:1:1 ratio to receive either EscharEx, placebo, or collagenase. In the first two weeks, the EscharEx and placebo groups will receive up to 8 daily applications, while the collagenase group will follow the product’s instructions for use (IFU). Each patient’s participation will last up to 14 weeks. Key safety endpoints, including the incidence and severity of adverse events (AEs), and time to complete wound closure, will be assessed. Additionally, exploratory efficacy endpoints will evaluate the incidence and time to complete debridement, granulation tissue formation, and wound bed preparation. To support this trial, MediWound has formed additional strategic R&D collaborations with Solventum and Mölnlycke Health Care. Solventum will supply the Coban™ 2 Two-Layer Compression System, while Mölnlycke will provide Mepilex®, Mepilex® Ag, Exufiber®, and Exufiber® Ag. These partnerships are designed to enhance consistency across study arms and ensure the use of best-in-class products, ultimately benefiting patient outcomes.공시 • Aug 06MediWound Ltd. Announces Positive Results from the U.S. NexoBrid Expanded Access Protocol (NEXT)MediWound Ltd. announced the positive results of the NEXT--an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid. NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid. Key Results of the NEXT Protocol Include: Efficacy (findings were consistent with Phase III studies results): 94.9% of adults and 100% of children achieved complete debridement. Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group. The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children. The time to complete eschar removal was less than one day for both adults and children. Healing and Hospitalization: The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children. The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children. Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB). Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable. NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories. NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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.공시 • Aug 02MediWound Ltd. to Report Q2, 2024 Results on Aug 14, 2024MediWound Ltd. announced that they will report Q2, 2024 results on Aug 14, 2024공시 • Jul 29MediWound Ltd. Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg UlcersMediWound Ltd. announced the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella. The publication, titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study", reports the results of the study. The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL®, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks. Key study outcomes include: A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm. Baseline characteristics of patients and wounds were comparable across all study arms. The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001). The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016). The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001). Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms. The safety profile of EscharEx was comparable to both NSSOC and the placebo.분석 기사 • Jul 23Market Participants Recognise MediWound Ltd.'s (NASDAQ:MDWD) Revenues Pushing Shares 43% HigherMediWound Ltd. ( NASDAQ:MDWD ) shares have had a really impressive month, gaining 43% after a shaky period beforehand...공시 • Jul 16MediWound Ltd. announced that it expects to receive $24.999994 million in funding from Mölnlycke Health Care AB and other investorsMediWound Ltd. announced that it has entered into a share purchase agreement with with several new and existing investors, including Mölnlycke Health Care ("Mölnlycke") to issue 1,453,488 common shares at an issue price of $17.20 per share for the gross proceeds of $24,999,993.6 on July 15, 2024. The Private Placement is being effected pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) contained in Section 4(a)(2) of and/or Regulation D under the Securities Act. Concurrently with the PIPE Offering, MediWound and Mölnlycke entered into a collaboration agreement to strengthen their partnership. The Collaboration Agreement also contains a stand-still clause that limits Mölnlycke's ownership to no more than 9.99% of the Company's issued and outstanding Ordinary Shares.. The PIPE Offering is expected to close within several days, subject to satisfaction of customary closing conditions.분석 기사 • Jun 01Analysts Have Made A Financial Statement On MediWound Ltd.'s (NASDAQ:MDWD) First-Quarter ReportAs you might know, MediWound Ltd. ( NASDAQ:MDWD ) recently reported its first-quarter numbers. Revenues of US$5.0m beat...공시 • May 31MediWound Ltd., Annual General Meeting, Jul 09, 2024MediWound Ltd., Annual General Meeting, Jul 09, 2024. Location: at the offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york 10020-1300, new york United States공시 • May 24MediWound Ltd. to Report Q1, 2024 Results on May 29, 2024MediWound Ltd. announced that they will report Q1, 2024 results on May 29, 2024분석 기사 • May 07Revenues Tell The Story For MediWound Ltd. (NASDAQ:MDWD) As Its Stock Soars 25%MediWound Ltd. ( NASDAQ:MDWD ) shares have continued their recent momentum with a 25% gain in the last month alone...Major Estimate Revision • Mar 28Consensus EPS estimates fall by 25%, revenue upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$23.8m to US$24.0m. Forecast EPS reduced from -US$1.53 to -US$1.91 per share. Pharmaceuticals industry in the US expected to see average net income decline 1.4% next year. Consensus price target of US$28.50 unchanged from last update. Share price fell 3.3% to US$15.10 over the past week.Reported Earnings • Mar 22Full year 2023 earnings released: US$0.74 loss per share (vs US$3.93 loss in FY 2022)Full year 2023 results: US$0.74 loss per share (improved from US$3.93 loss in FY 2022). Revenue: US$18.7m (down 30% from FY 2022). Net loss: US$6.72m (loss narrowed 66% from FY 2022). Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 9.2% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings.공시 • Mar 15MediWound Ltd. to Report Q4, 2023 Results on Mar 21, 2024MediWound Ltd. announced that they will report Q4, 2023 results on Mar 21, 2024분석 기사 • Feb 28We're Hopeful That MediWound (NASDAQ:MDWD) Will Use Its Cash WiselyEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • Feb 13Mediwound Ltd. Announces Positive Results in Head-To-Head Comparison of Escharex® Vs. Santyl® Within the Chronex Phase Ii Randomized Controlled StudyMediWound Ltd. announced the results of head-to-head comparison analyses of EscharEx, the Company’s lead asset in development for chronic wounds, to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers. SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States. Results from the previously disclosed Phase II study (ChronEx) which evaluated the safety and efficacy of EscharEx, demonstrated the superiority of EscahrEx vs. a gel vehicle (placebo) and non-surgical standard of care (NSSOC), in achieving complete debridement of non-viable tissue and promotion of granulation tissue (healthy, highly vascularized tissue). The secondary analyses announced assessed the incidence and time to complete debridement, complete granulation, and wound closure in patients treated with EscharEx (n=46) compared to a sub-group of patients who were treated with SANTYL (n=8).분석 기사 • Feb 01Optimistic Investors Push MediWound Ltd. (NASDAQ:MDWD) Shares Up 26% But Growth Is LackingMediWound Ltd. ( NASDAQ:MDWD ) shares have continued their recent momentum with a 26% gain in the last month alone. The...공시 • Jan 10Mediwound Announces That FDA Has Accepted for Review the Supplement to the Nexobrid BLA to Include Pediatric Patients with Severe Thermal BurnsMediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns. The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.공시 • Dec 22Mediwound Ltd. Announces Publication of Escharex Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial LoadsMediWound Ltd. announced the publication of a peer-reviewed paper, titled "An Open-label, Proof of Concept Study, Assessing the Effects of Bromelain-Based Enzymatic Debridement on Biofilm and Microbial Loads in Patients with Venous Leg and Diabetic Foot Ulcers" in the December 2023 issue of WOUNDS Journal. The paper highlights results from a Phase II study, which explored the mechanism of action of EscharEx, a novel Bromelain based enzymatic debridement agent, in 12 patients with either venous leg ulcers (VLUs) or diabetic foot ulcers (DFUs). Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs. Key findings: 70% of the patients (7/10) that completed the study achieved complete debridement within a median time of 5.5 days. An average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. Together with the outcomes of previous Phase II study results, this study furthers the understanding of the effects of EscharEx. It demonstrates its effectiveness not only in enzymatic debridement and promotion of granulation tissue, but potentially also in reducing biofilm and bacterial load. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company's lead drug under development, EscharEx®?. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound's pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.분석 기사 • Dec 18MediWound Ltd.'s (NASDAQ:MDWD) 26% Share Price Surge Not Quite Adding UpMediWound Ltd. ( NASDAQ:MDWD ) shareholders would be excited to see that the share price has had a great month, posting...Reported Earnings • Nov 24Third quarter 2023 earnings: EPS exceeds analyst expectationsThird quarter 2023 results: US$0.24 loss per share (improved from US$0.88 loss in 3Q 2022). Revenue: US$4.78m (down 18% from 3Q 2022). Net loss: US$2.20m (loss narrowed 48% from 3Q 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 40%. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings.Major Estimate Revision • Nov 23Consensus EPS estimates upgraded to US$0.75 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.34 to -US$0.753 per share. Revenue forecast steady at US$18.4m. Pharmaceuticals industry in the US expected to see average net income growth of 43% next year. Consensus price target of US$28.00 unchanged from last update. Share price rose 7.3% to US$8.70 over the past week.공시 • Nov 22MediWound Ltd. Appoints Shmulik Hess as Chief Operating Officer and Chief Commercial Officer, Effective December 1, 2023MediWound Ltd. announced the appointment of Shmulik Hess, Ph.D. to the positions of Chief Operating Officer and Chief Commercial Officer effective as of December 1, 2023. Dr. Hess will lead and oversee all operational and commercial activities at MediWound. Dr. Hess has over two decades of extensive expertise in drug development and commercial operations in healthcare. He possesses a wealth of leadership experience in operational strategies, sales, and commercial facets within the global biopharma industry. Prior to joining MediWound, he served as Chief Executive Officer at Tabby Therapeutics, Enlivex Therapeutics and Valin Technologies. Formerly, Dr. Hess served as a global operations executive at SciGen Ltd. Dr. Hess is the inventor of multiple patents and author of numerous publications in peer reviewed scientific journals. He received his Ph.D. in Pharmaceutical Science from the Hebrew University, Israel and was a research fellow at Harvard-MIT Health Sciences and Technology (HST).공시 • Nov 15MediWound Ltd. to Report Q3, 2023 Results on Nov 21, 2023MediWound Ltd. announced that they will report Q3, 2023 results at 9:30 AM, US Eastern Standard Time on Nov 21, 2023공시 • Nov 14MediWound Ltd Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric PatientsMediWound Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently. This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages.분석 기사 • Sep 29MediWound Ltd. (NASDAQ:MDWD) Stock Rockets 28% As Investors Are Less Pessimistic Than ExpectedMediWound Ltd. ( NASDAQ:MDWD ) shares have had a really impressive month, gaining 28% after a shaky period beforehand...공시 • Sep 27MediWound Ltd. Secures Additional U.S. Department of Defense Funding to Advance NexoBrid Development for the U.S. ArmyMediWound Ltd. announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound additional funding to develop NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $6.5 million project budget will advance the development of a new, temperature stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.New Risk • Sep 22New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 63% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.2m net loss in 3 years). Market cap is less than US$100m (US$86.8m market cap).공시 • Sep 22MediWound Ltd. Announces U.S. Commercial Availability of NexoBrid®? for the Treatment of Severe Thermal Burns in AdultsMediWound Ltd. announced the U.S. commercial availability of NexoBrid®? (anacaulase-bcdb) for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis. Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue. NexoBrid selectively targets eschar while preserving viable tissue, enabling more rapid and precise eschar removal, which may reduce the need for subsequent skin grafting and lessen patient trauma. Each year, approximately 40,000 people are hospitalized in the U.S. for burn-related injuries, and of those patients, more than 30,000 of them require some level of eschar removal, representing a $300 million addressable market for NexoBrid in the U.S. NexoBrid can be applied in up to two applications of four hours each.Board Change • Sep 01High number of new and inexperienced directorsThere are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. No highly experienced directors. Independent Director Vickie Driver is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.Reported Earnings • Aug 18Second quarter 2023 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2023 results: EPS: US$0.099 (up from US$0.92 loss in 2Q 2022). Revenue: US$4.77m (up 2.2% from 2Q 2022). Net income: US$916.0k (up US$5.27m from 2Q 2022). Profit margin: 19% (up from net loss in 2Q 2022). The move to profitability was primarily driven by lower expenses. Revenue exceeded analyst estimates by 14%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 27% per year, which means it is performing significantly worse than earnings.Price Target Changed • Aug 17Price target decreased by 20% to US$27.25Down from US$34.00, the current price target is an average from 4 analysts. New target price is 205% above last closing price of US$8.92. Stock is down 40% over the past year. The company is forecast to post a net loss per share of US$1.51 next year compared to a net loss per share of US$3.93 last year.공시 • Aug 08MediWound Ltd. to Report Q2, 2023 Results on Aug 15, 2023MediWound Ltd. announced that they will report Q2, 2023 results on Aug 15, 2023공시 • Aug 03MediWound Ltd. Announces Commercial Launch of NexoBrid®? in JapanMediWound Ltd. announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid®? in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan. NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns. The prospects are excellent for it becoming the new standard-of-care for serious and life-threatening burns, bringing significant benefits to providers and patients alike. Given long-term relationship with MediWound, have been anticipating this moment. NexoBrid is approved in over 40 countries, including in the United States and in the European Union where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA). 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% of total body surface area 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 less blood loss during eschar removal.공시 • Jul 11Mediwound Ltd. Announces Positive Results in Its U.S. Phase I/Ii Study of Mw005 for the Treatment of Basal Cell CarcinomaMediWound Ltd. announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data show MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. The Phase I/II study is an open-label, multi-centered, randomized clinical trial designed to evaluate the safety and efficacyof MW005 in patients with BCC. All of the patients enrolled in the study had histologically confirmed superficial or nodular BCC. Enrolled patients received seven topical applications of MW005 once every other day for fourteen days. Eight weeks following the last treatment, all patients underwent a complete precisional biopsy. The excised specimen was subjected to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy assessments, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance. Fifteen patients were treated with MW005 and completed the study. Results showed MW005 to be safe and well-tolerated, with a high level of patient compliance. While the primary focus of the trial was on safety and tolerability, it is worth noting that based on clinical assessments, eleven out of fifteen patients achieved complete clearance of their BCCs; the majority of these patients also had histologically confirmed complete clearance. Data comprising clinical and histological outcomes, supported by extensive patient follow-up, will be featured at an upcoming scientific conference in 2023.These results corroborate the previous proof-of-concept study published by Prof. Rosenberg et al (Basal CellCarcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report;TODJ-15-39 [1], 2021), where seven BCC tumors treated with MW005 were completely removed based on clinicalassessment, and none reoccurred over the subsequent 24 months.공시 • Jul 04MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study DesignMediWound Ltd. announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization. The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies. In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each. Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid®, which has been approved for debridement of thermal burns in the U.S. and Europe.Major Estimate Revision • Jun 04Consensus revenue estimates fall by 12%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$20.5m to US$18.0m. Forecast losses increased from -US$1.34 to -US$1.51 per share. Pharmaceuticals industry in the US expected to see average net income decline 18% next year. Consensus price target broadly unchanged at US$34.00. Share price fell 8.3% to US$8.91 over the past week.Reported Earnings • May 31First quarter 2023 earnings: EPS and revenues miss analyst expectationsFirst quarter 2023 results: US$0.44 loss per share. Revenue: US$3.80m (down 14% from 1Q 2022). Net loss: US$3.69m (loss widened 2.9% from 1Q 2022). Revenue missed analyst estimates by 26%. Earnings per share (EPS) also missed analyst estimates by 144%. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 7.2% growth forecast for the Pharmaceuticals industry in the US.공시 • May 13MediWound Ltd. to Report Q1, 2023 Results on May 30, 2023MediWound Ltd. announced that they will report Q1, 2023 results on May 30, 2023Reported Earnings • Mar 17Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFull year 2022 results: US$3.93 loss per share (further deteriorated from US$3.48 loss in FY 2021). Revenue: US$26.5m (up 12% from FY 2021). Net loss: US$19.6m (loss widened 45% from FY 2021). Revenue exceeded analyst estimates by 23%. Earnings per share (EPS) missed analyst estimates by 81%. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 5.0% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 45% per year but the company’s share price has only fallen by 1% per year, which means it has not declined as severely as earnings.Major Estimate Revision • Jan 03Consensus estimates of losses per share improve by 10%The consensus outlook for earnings per share (EPS) in 2022 has improved. 2022 revenue forecast increased from US$19.6m to US$21.1m. EPS estimate increased from -US$3.36 per share to -US$3.02 per share. Pharmaceuticals industry in the US expected to see average net income growth of 6.9% next year. Consensus price target down from US$43.50 to US$37.00. Share price rose 15% to US$13.29 over the past week.Price Target Changed • Dec 23Price target decreased to US$43.50Down from US$49.70, the current price target is an average from 5 analysts. New target price is 278% above last closing price of US$11.50. Stock is down 27% over the past year. The company is forecast to post a net loss per share of US$3.36 next year compared to a net loss per share of US$3.48 last year.Reported Earnings • Nov 16Third quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behindThird quarter 2022 results: US$0.13 loss per share (further deteriorated from US$0.12 loss in 3Q 2021). Revenue: US$5.80m (down 8.9% from 3Q 2021). Net loss: US$4.20m (loss widened 26% from 3Q 2021). Revenue exceeded analyst estimates by 26%. Earnings per share (EPS) missed analyst estimates by 33%. Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 44 percentage points per year, which is a significant difference in performance.Board Change • Nov 16High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Board Change • Nov 02High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Board Change • Nov 02High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.Price Target Changed • Oct 15Price target increased to US$7.20Up from US$6.00, the current price target is an average from 5 analysts. New target price is 445% above last closing price of US$1.32. Stock is down 61% over the past year. The company is forecast to post a net loss per share of US$0.43 next year compared to a net loss per share of US$0.50 last year.Seeking Alpha • Sep 20MediWound's NexoBrid for thermal burns in children gets EMA reviewThe European Medicines Agency (EMA) validated for review MediWound's (NASDAQ:MDWD) application for expanded use of NexoBrid in children aged newborn through 18 years of age for removal of eschar (dead tissue) with deep partial-and full-thickness thermal burn wounds. The submission is backed by interim data from a global, phase 3 trial (CIDS - Children Innovative Debridement Study), EU phase 3 study (MW2004-11-02) and phase 2 studies conducted during the clinical development of NexoBrid. NexoBrid is also under review in the U.S. for use in adults.Major Estimate Revision • Aug 16Consensus revenue estimates fall by 14%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$21.3m to US$18.4m. Forecast losses increased from -US$0.37 to -US$0.44 per share. Pharmaceuticals industry in the US expected to see average net income decline 3.6% next year. Consensus price target down from US$6.25 to US$6.00. Share price rose 27% to US$2.24 over the past week.Reported Earnings • Aug 11Second quarter 2022 earnings: EPS and revenues miss analyst expectationsSecond quarter 2022 results: US$0.13 loss per share (down from US$0.12 loss in 2Q 2021). Revenue: US$4.67m (down 23% from 2Q 2021). Net loss: US$4.35m (loss widened 36% from 2Q 2021). Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 34%. Over the next year, revenue is forecast to grow 13%, compared to a 16% growth forecast for the industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 71 percentage points per year, which is a significant difference in performance.분석 기사 • Aug 11Need To Know: Analysts Just Made A Substantial Cut To Their MediWound Ltd. (NASDAQ:MDWD) EstimatesToday is shaping up negative for MediWound Ltd. ( NASDAQ:MDWD ) shareholders, with the analysts delivering a...Price Target Changed • Aug 09Price target increased to US$6.90Up from US$6.25, the current price target is an average from 6 analysts. New target price is 290% above last closing price of US$1.77. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$0.37 next year compared to a net loss per share of US$0.50 last year.Seeking Alpha • Aug 09MediWound GAAP EPS of -$0.13 misses by $0.03, revenue of $4.67M misses by $0.61MMediWound press release (NASDAQ:MDWD): Q2 GAAP EPS of -$0.13 misses by $0.03. Revenue of $4.67M (-22.8% Y/Y) misses by $0.61M.Seeking Alpha • Aug 03MediWound refiling for NexoBrid to treat severe thermal burns gets FDA reviewThe U.S. Food and Drug Administration (FDA) accepted for review MediWound's (NASDAQ:MDWD) re-submitted biologics license application (BLA) seeking approval of NexoBrid for eschar (dead tissue) removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA is expected to make a decision by Jan. 1, 2023. MediWound said the the BLA re-filing adds to manufacturing data, preclinical and clinical studies — including a U.S. phase 3 study — previously submitted. Vericel (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid, according to MediWound. MediWound noted that NexoBrid development has been supported in part with federal funding from U.S. Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services.Seeking Alpha • Jul 07MediWound adds 13% after favorable data for ulcer candidateIsraeli biopharma MediWound (NASDAQ:MDWD) climbed ~13% in the pre-market Thursday after the company announced positive data from a Phase 2 trial designed to evaluate its wound candidate EscharEx as a therapy for the debridement of lower leg ulcers. The U.S.-based open-label, single-arm trial involved 12 patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). 70% of patients achieved complete debridement during the treatment course after about eight applications of EscharEx, a treatment designed for the outpatient setting. There was complete debridement in about 3.9 applications on average. After a two-week follow up period, data indicated an average of 35% reduction of wound size. “The data from our pharmacology study corroborates the results of our previous Phase 2 studies, and clearly supports EscharEx as a potential rapid and effective, non-surgical debriding agent,” MediWound (MDWD) Chief Executive Ofer Gonen said. The latest trial results for EscharEx come only days after Gonen assumed duties as the company’s new CEO.Seeking Alpha • Jun 30MediWound taps Tzvi Palash as COOTzvi Palash has been appointed as COO at biopharmaceutical company MediWound (NASDAQ:MDWD). Palash brings over 35 years of experience, having previously served at Enlivex, where he led the design and construction of the new cGMP manufacturing facility. At MediWound, Palash will be responsible for leading all operational activities.분석 기사 • Jun 24Is MediWound (NASDAQ:MDWD) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...Reported Earnings • May 18First quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFirst quarter 2022 results: US$0.13 loss per share (down from US$0.10 loss in 1Q 2021). Revenue: US$4.41m (down 25% from 1Q 2021). Net loss: US$3.59m (loss widened 26% from 1Q 2021). Revenue exceeded analyst estimates by 2.6%. Earnings per share (EPS) missed analyst estimates by 4.3%. Over the next year, revenue is forecast to grow 6.0%, compared to a 13% growth forecast for the industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 51 percentage points per year, which is a significant difference in performance.Price Target Changed • Apr 27Price target decreased to US$6.25Down from US$6.92, the current price target is an average from 6 analysts. New target price is 188% above last closing price of US$2.17. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.50 last year.Major Estimate Revision • Mar 24Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$25.7m to US$20.9m. EPS estimate increased from -US$0.40 to -US$0.34 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target down from US$6.92 to US$6.25. Share price was steady at US$1.94 over the past week.Price Target Changed • Mar 22Price target decreased to US$6.25Down from US$6.92, the current price target is an average from 6 analysts. New target price is 224% above last closing price of US$1.93. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.50 last year.Reported Earnings • Mar 18Full year 2021 earnings: EPS exceeds analyst expectationsFull year 2021 results: US$0.50 loss per share (down from US$0.34 loss in FY 2020). Revenue: US$23.8m (up 9.2% from FY 2020). Net loss: US$13.6m (loss widened 46% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.0%. Over the next year, revenue is forecast to grow 6.1%, compared to a 17% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 37 percentage points per year, which is a significant difference in performance.지급의 안정성과 성장배당 데이터 가져오는 중안정적인 배당: 과거에 MDWD 의 주당 배당금이 안정적이었는지 판단하기에는 데이터가 부족합니다.배당금 증가: MDWD 의 배당금 지급이 증가했는지 판단하기에는 데이터가 부족합니다.배당 수익률 vs 시장MediWound 배당 수익률 vs 시장MDWD의 배당 수익률은 시장과 어떻게 비교되나요?구분배당 수익률회사 (MDWD)n/a시장 하위 25% (US)1.4%시장 상위 25% (US)4.3%업계 평균 (Pharmaceuticals)2.1%분석가 예측 (MDWD) (최대 3년)n/a주목할만한 배당금: 회사가 최근 지급을 보고하지 않았기 때문에 하위 25%의 배당금 지급자에 대해 MDWD 의 배당 수익률을 평가할 수 없습니다.고배당: 회사가 최근 지급을 보고하지 않았기 때문에 배당금 지급자의 상위 25%에 대해 MDWD 의 배당 수익률을 평가할 수 없습니다.주주 대상 이익 배당수익 보장: 배당금 지급이 수익으로 충당되는지 확인하기 위해 MDWD 의 지급 비율을 계산하기에는 데이터가 부족합니다.주주 현금 배당현금 흐름 범위: MDWD 에서 지급을 보고하지 않았기 때문에 배당 지속 가능성을 계산할 수 없습니다.높은 배당을 제공하는 우량 기업 찾기7D1Y7D1Y7D1YUS 시장에서 배당이 강한 기업.View Management기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/20 11:08종가2026/05/20 00:00수익2025/12/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스MediWound Ltd.는 13명의 분석가가 다루고 있습니다. 이 중 6명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Scott HenryAlliance Global PartnersDavid MarisBMO Capital Markets Equity ResearchSwayampakula RamakanthH.C. Wainwright & Co.10명의 분석가 더 보기
공시 • May 07MediWound Ltd. to Report Q1, 2026 Results on May 27, 2026MediWound Ltd. announced that they will report Q1, 2026 results Pre-Market on May 27, 2026
공시 • Apr 08Mediwound Ltd. Presents New Escharex Data At Wound Care ConferencesMediWound Ltd. announced multiple oral and poster presentations at three wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2026, taking place April 8–12 in Charlotte, North Carolina, and the European Wound Management Association (EWMA) 2026, taking place May 6–8 in Bremen, Germany. The presentations will showcase new preclinical and clinical data supporting EscharEx’s differentiated mechanism of action, clinical performance, and advancement of its ongoing Phase III development in venous leg ulcers (VLUs), as well as its planned expansion into diabetic foot ulcers (DFUs) and pressure ulcers. A new preclinical mechanistic study demonstrated superior debridement with EscharEx versus SANTYL across multiple non-viable tissue components, while gene expression analysis revealed that EscharEx specifically activates molecular pathways that support wound healing. New analysis demonstrating improved long-term scar outcomes following enzymatic debridement compared to surgical and non-surgical standard of care. New data on time to wound closure following autograft or placental-derived allografts in VLUs, supporting the statistical assumptions of the ongoing VALUE Phase III study. Post-hoc analysis from the ChronEx Phase II multicenter randomized controlled trial highlighting that adequate wound bed preparation is a prerequisite for wound closure, supporting the co-primary endpoint of the VALUE Phase III study. Scientific session highlighting the expanding role of bromelain-based enzymatic therapy from acute burn care to chronic wound management, including clinical case studies, comparison to SANTYL, Phase III VALUE trial updates in VLUs, and future development in DFUs and pressure injuries. Post-hoc analysis demonstrates the efficacy of bromelain-based enzymatic debridement in DFUs, supporting ongoing development in this indication. Additional analyses from the ChronEx Phase II randomized controlled trial, further strengthening the clinical foundation for the ongoing VALUE Phase III study. EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLUs) is underway, with clinical studies in diabetic foot ulcers (DFUs) and pressure ulcers (PUs) planned for H2 2026. EscharEx has demonstrated advantages over the leading enzymatic debridement agent and targets a substantial global market opportunity.
공시 • Apr 01MediWound Ltd., Annual General Meeting, May 06, 2026MediWound Ltd., Annual General Meeting, May 06, 2026. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york,10020-1300., new york, United States
공시 • Mar 05Mediwound Ltd. Reaffirms Revenue Guidance for the Year 2026, 2027 and 2028MediWound Ltd. reaffirmed its revenue guidance for the year 2026, 2027 and 2028. For the year 2026, the company expect revenue of $24–26 million. For the year 2027, the company expect revenue of $32–35 million. For the year 2028, the company expect revenue of $50–55 million.
공시 • Feb 19MediWound Ltd. to Report Q4, 2025 Results on Mar 05, 2026MediWound Ltd. announced that they will report Q4, 2025 results on Mar 05, 2026
분석 기사 • Jan 14We Think MediWound (NASDAQ:MDWD) Can Afford To Drive Business GrowthWe can readily understand why investors are attracted to unprofitable companies. For example, although...
공시 • Jan 13Mediwound Ltd. Updates Revenue Guidance for the Fiscal Year 2026 , 2027, and 2028MediWound Ltd. updated revenue guidance for the fiscal year 2026, 2027, and 2028. For the 2026, Updated revenue guidance projects $24–26 million. For the 2027, updated revenue guidance projects $32–35 million. For the 2028, updated revenue guidance projects $50–55 million.
공시 • Dec 11MediWound Ltd. Reports New Clinical Data Demonstrating NexoBrid's Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast InjuriesMediWound Ltd. announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid®? substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries. Traumatic tattoos occur when high-velocity accidents or blasts drive materials such as asphalt, dirt, glass, or metallic particles (shrapnel) into the skin, often leaving not only permanent dark discoloration but also causing aesthetic deformities, functional impairment, and increased risk of inflammation or infection. Current standard of care relies on aggressive non-selective mechanical scrubbing, which may leave embedded particles behind and may risk damage to viable tissue. NexoBrid development has been supported with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C.
분석 기사 • Nov 23The MediWound Ltd. (NASDAQ:MDWD) Third-Quarter Results Are Out And Analysts Have Published New ForecastsLast week, you might have seen that MediWound Ltd. ( NASDAQ:MDWD ) released its third-quarter result to the market. The...
공시 • Nov 05MediWound Ltd. to Report Q3, 2025 Results on Nov 20, 2025MediWound Ltd. announced that they will report Q3, 2025 results on Nov 20, 2025
분석 기사 • Oct 16Getting In Cheap On MediWound Ltd. (NASDAQ:MDWD) Might Be DifficultYou may think that with a price-to-sales (or "P/S") ratio of 12.6x MediWound Ltd. ( NASDAQ:MDWD ) is a stock to avoid...
공시 • Sep 30MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million.MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 1,734,105 Price\Range: $17.3 Discount Per Security: $1 Transaction Features: Registered Direct Offering
공시 • Sep 25Mediwound Ltd. Expands Global Reach with Marketing Approval of Nexobrid®? in AustraliaMediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®?, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns. With this approval, NexoBrid is now authorized in 45 countries worldwide, reflecting its growing recognition as a new standard of care in burn management. MediWound's exclusive partner in Australia, Balance Medical, expects to initiate commercial launch in the fourth quarter of 2025. MediWound's manufacturing expansion, on track for completion by year-end 2025, will support this launch and future global demand.
Seeking Alpha • Sep 02MediWound Is A Buy Opportunity On The DipSummary MediWound is a niche biotech with strong R&D, FDA-approved products, and a promising pipeline, but remains underfollowed and volatile. Despite weak current performance and negative metrics, the company has a solid cash runway, no debt, and recent strategic investments. NexoBrid's expanded approvals and rising hospital orders, plus a new facility, position MediWound for significant revenue growth in burn care. The stock is a high-risk, high-reward buy opportunity with potential for future takeovers and strong upside if commercialization succeeds. Read the full article on Seeking Alpha
공시 • Aug 14Mediwound Ltd. Announces New Escharex Phase Ii Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg UlcersMediWound Ltd. announced the publication of "The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the enzymatic therapies for non-surgical tissue repair, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue. Key Findings: Wounds that failed to achieve WBP had a 90% probability of not healing (Negative Predictive Value = 90%) Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004); Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005); Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001). These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx's therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers. Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: "While wound bed preparation has long been accepted as the concept foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation.
공시 • Aug 04MediWound Ltd. to Report Q2, 2025 Results on Aug 14, 2025MediWound Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 14, 2025
공시 • May 21MediWound Ltd. Reaffirms Revenue Guidance for the Year 2025MediWound Ltd. reaffirmed revenue guidance for the year 2025. For the full-year 2025 revenue guidance reaffirmed at $24 million.
분석 기사 • May 14We Think MediWound (NASDAQ:MDWD) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
공시 • May 14MediWound Ltd. Announces Publication of Phase II EscharEx® Data Demonstrating Superiority over Collagenase in Venous Leg UlcersMediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company's Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx®? compared with Collagenase ointment (SANTYL®?), the only FDA-cleared enzymatic debridement agent commercially available for the treatment of dermal ulcers. The article, titled "Bromelain-Based Debridement Versus Collagenase Ointment Debridement Debridement Debridement of Venous Leg Ulcers: Post Hoc Analysis of the ChronEx Trial," appears in the April 2025 edition of Wounds (Index 2025;37(4):166-173) and compares outcomes in a subgroup of patients from the non-surgical standard of care arm treated with SANTYL (n=8) to those treated with EscharEx (n=46). EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
공시 • May 05MediWound Ltd. to Report Q1, 2025 Results on May 21, 2025MediWound Ltd. announced that they will report Q1, 2025 results on May 21, 2025
공시 • Apr 28MediWound Ltd. to Present New EscharEx®? Data At Leading Wound Care ConferencesMediWound Ltd. announced that it will present 10 scientific abstracts--including both oral and poster presentations-- at two of the world's premier wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, taking place April 30-May 3 in Grapevine, Texas. The presentations will feature new preclinical and clinical data on EscharEx®?, MediWound's investigational enzymatic therapy for chronic wounds. The findings offer important insights into EscharEx's multitargeted and selective proteolytic activity on non-viable tissue. Results from a novel hard-to-heal wound model demonstrating EscharEx's superior debridement efficacy compared to collagenase SANTYL®? Symposium on Advanced Wound care (SAWC). Overview of EscharEx's mechanism of action, including in vitro studies and clinical findings from EscharEx and NexoBrid®? Case studies highlighting EscharEx's use in advanced DFUs (Wagner grade 2) and VLUs. Post-hoc analyses in DFUs and preliminary strategy for the planned clinical trial. Update on the VALUE Phase III study design and enrollment progress. The VALUE Phase III study is currently enrolling patients with VLUs across multiple sites, building on positive results from three completed Phase II studies that demonstrated EscharEx's efficacy, safety, and potential to enhance standard wound care practices.
분석 기사 • Apr 18What You Can Learn From MediWound Ltd.'s (NASDAQ:MDWD) P/SWith a price-to-sales (or "P/S") ratio of 9.1x MediWound Ltd. ( NASDAQ:MDWD ) may be sending very bearish signals at...
공시 • Apr 08MediWound Ltd., Annual General Meeting, May 15, 2025MediWound Ltd., Annual General Meeting, May 15, 2025. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, 10020-1300., new york United States
새로운 내러티브 • Apr 02FDA Approval And Phase III Trial Will Expand Wound Care Strong EscharEx results and strategic partnerships boost potential sales growth, leveraging Medicare policies and Phase III trials for greater revenue prospects.
공시 • Mar 03MediWound Ltd. to Report Q4, 2024 Results on Mar 19, 2025MediWound Ltd. announced that they will report Q4, 2024 results on Mar 19, 2025
공시 • Feb 26MediWound Ltd. Announces Phase III CIDS Publication on NexoBrid for Pediatric Burn CareMediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI). The study evaluated the efficacy and safety of NexoBrid®? compared to the standard of care (SOC) in pediatric patients with deep partial- and full-thickness thermal burns. The publication, titled "Open-Label RCT of the Efficacy and Safety of NexoBrid Compared to SOC in Children with Burns," presents findings that supported the label expansion of NexoBrid for pediatric patients in the E.U. (2023) and U.S. (2024). These results reinforce NexoBrid's clinical benefits as a rapid, effective, and non-surgical alternative for eschar removal in pediatric burn patients, validating its significance as a transformative treatment in burn care. Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burn, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx®?, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the currently available $375+ million drug for wound debridement, presenting a unique opportunity for significant market growth.
공시 • Feb 12MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg UlcersMediWound Ltd. announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the U.S. and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over two weeks, followed by ten weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks. The study co-primary endpoints are the incidence of complete debridement and the incidence of complete wound closure. Secondary endpoints include the incidence of complete granulation tissue, time to debridement, time to complete wound closure, and changes in wound area. Safety and tolerability of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026. To support the trial, MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes. In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025, comparing EscharEx to collagenase in VLU patients. This Phase II trial is designed to support the U.S. Biologics License Application (BLA) submission for EscharEx and strengthen MediWound’s commercialization strategy. Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026.
분석 기사 • Feb 12Is MediWound (NASDAQ:MDWD) In A Good Position To Invest In Growth?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
분석 기사 • Jan 09MediWound Ltd.'s (NASDAQ:MDWD) P/S Still Appears To Be ReasonableWhen you see that almost half of the companies in the Pharmaceuticals industry in the United States have price-to-sales...
분석 기사 • Nov 29Earnings Update: MediWound Ltd. (NASDAQ:MDWD) Just Reported And Analysts Are Trimming Their ForecastsMediWound Ltd. ( NASDAQ:MDWD ) just released its latest quarterly report and things are not looking great. It was not a...
공시 • Nov 26MediWound Ltd. Revises Revenue Guidance for 2024MediWound Ltd. revised revenue guidance for 2024. The Company anticipates $20 million in total revenue for 2024, compared to prior guidance of $24 million.
공시 • Nov 12MediWound Ltd. to Report Q3, 2024 Results on Nov 26, 2024MediWound Ltd. announced that they will report Q3, 2024 results on Nov 26, 2024
Seeking Alpha • Oct 29MediWound Is A Healthy InvestmentSummary MediWound is a long-term buy opportunity with significant upside potential, driven by its innovative wound and lesion care products in a strong, growing industry. Despite current financial struggles, including increased losses and low margins, MediWound's revenue is expected to grow, and it garners support from government and industry investments. MDWD has shown strong momentum, nearly doubling in price YTD, and is backed by a healthy mix of institutional and private investors. Retail value investors with patience and unneeded cash can safely accumulate MediWound stock, anticipating positive growth and a brighter 2025 revenue outlook. Read the full article on Seeking Alpha
공시 • Oct 10MediWound Ltd. Announces Phase II Head-To-Head Study Evaluating EscharEx®? vs. Collagenase in Patients with Venous Leg UlcersMediWound Ltd. announced that it will be initiating a controlled, multicenter Phase II clinical study evaluating EscharEx® against collagenase ointment (marketed as SANTYL® in the U.S. and IRUXOL® in Europe) for the treatment of venous leg ulcers (VLUs). Scheduled to commence in 2025, this Phase II study will run concurrently with the Company’s Phase III trial in VLU patients. The study is designed to support the Biologics License Application (BLA) for EscharEx and plays a key role in MediWound’s commercialization strategy. The randomized, prospective study will enroll 45 patients across multiple sites in the U.S. and Europe. VLU patients will be randomly assigned in a 1:1:1 ratio to receive either EscharEx, placebo, or collagenase. In the first two weeks, the EscharEx and placebo groups will receive up to 8 daily applications, while the collagenase group will follow the product’s instructions for use (IFU). Each patient’s participation will last up to 14 weeks. Key safety endpoints, including the incidence and severity of adverse events (AEs), and time to complete wound closure, will be assessed. Additionally, exploratory efficacy endpoints will evaluate the incidence and time to complete debridement, granulation tissue formation, and wound bed preparation. To support this trial, MediWound has formed additional strategic R&D collaborations with Solventum and Mölnlycke Health Care. Solventum will supply the Coban™ 2 Two-Layer Compression System, while Mölnlycke will provide Mepilex®, Mepilex® Ag, Exufiber®, and Exufiber® Ag. These partnerships are designed to enhance consistency across study arms and ensure the use of best-in-class products, ultimately benefiting patient outcomes.
공시 • Aug 06MediWound Ltd. Announces Positive Results from the U.S. NexoBrid Expanded Access Protocol (NEXT)MediWound Ltd. announced the positive results of the NEXT--an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid. NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid. Key Results of the NEXT Protocol Include: Efficacy (findings were consistent with Phase III studies results): 94.9% of adults and 100% of children achieved complete debridement. Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group. The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children. The time to complete eschar removal was less than one day for both adults and children. Healing and Hospitalization: The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children. The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children. Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB). Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable. NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories. NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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.
공시 • Aug 02MediWound Ltd. to Report Q2, 2024 Results on Aug 14, 2024MediWound Ltd. announced that they will report Q2, 2024 results on Aug 14, 2024
공시 • Jul 29MediWound Ltd. Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg UlcersMediWound Ltd. announced the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella. The publication, titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study", reports the results of the study. The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL®, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks. Key study outcomes include: A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm. Baseline characteristics of patients and wounds were comparable across all study arms. The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001). The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016). The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001). Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms. The safety profile of EscharEx was comparable to both NSSOC and the placebo.
분석 기사 • Jul 23Market Participants Recognise MediWound Ltd.'s (NASDAQ:MDWD) Revenues Pushing Shares 43% HigherMediWound Ltd. ( NASDAQ:MDWD ) shares have had a really impressive month, gaining 43% after a shaky period beforehand...
공시 • Jul 16MediWound Ltd. announced that it expects to receive $24.999994 million in funding from Mölnlycke Health Care AB and other investorsMediWound Ltd. announced that it has entered into a share purchase agreement with with several new and existing investors, including Mölnlycke Health Care ("Mölnlycke") to issue 1,453,488 common shares at an issue price of $17.20 per share for the gross proceeds of $24,999,993.6 on July 15, 2024. The Private Placement is being effected pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) contained in Section 4(a)(2) of and/or Regulation D under the Securities Act. Concurrently with the PIPE Offering, MediWound and Mölnlycke entered into a collaboration agreement to strengthen their partnership. The Collaboration Agreement also contains a stand-still clause that limits Mölnlycke's ownership to no more than 9.99% of the Company's issued and outstanding Ordinary Shares.. The PIPE Offering is expected to close within several days, subject to satisfaction of customary closing conditions.
분석 기사 • Jun 01Analysts Have Made A Financial Statement On MediWound Ltd.'s (NASDAQ:MDWD) First-Quarter ReportAs you might know, MediWound Ltd. ( NASDAQ:MDWD ) recently reported its first-quarter numbers. Revenues of US$5.0m beat...
공시 • May 31MediWound Ltd., Annual General Meeting, Jul 09, 2024MediWound Ltd., Annual General Meeting, Jul 09, 2024. Location: at the offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york 10020-1300, new york United States
공시 • May 24MediWound Ltd. to Report Q1, 2024 Results on May 29, 2024MediWound Ltd. announced that they will report Q1, 2024 results on May 29, 2024
분석 기사 • May 07Revenues Tell The Story For MediWound Ltd. (NASDAQ:MDWD) As Its Stock Soars 25%MediWound Ltd. ( NASDAQ:MDWD ) shares have continued their recent momentum with a 25% gain in the last month alone...
Major Estimate Revision • Mar 28Consensus EPS estimates fall by 25%, revenue upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$23.8m to US$24.0m. Forecast EPS reduced from -US$1.53 to -US$1.91 per share. Pharmaceuticals industry in the US expected to see average net income decline 1.4% next year. Consensus price target of US$28.50 unchanged from last update. Share price fell 3.3% to US$15.10 over the past week.
Reported Earnings • Mar 22Full year 2023 earnings released: US$0.74 loss per share (vs US$3.93 loss in FY 2022)Full year 2023 results: US$0.74 loss per share (improved from US$3.93 loss in FY 2022). Revenue: US$18.7m (down 30% from FY 2022). Net loss: US$6.72m (loss narrowed 66% from FY 2022). Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 9.2% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings.
공시 • Mar 15MediWound Ltd. to Report Q4, 2023 Results on Mar 21, 2024MediWound Ltd. announced that they will report Q4, 2023 results on Mar 21, 2024
분석 기사 • Feb 28We're Hopeful That MediWound (NASDAQ:MDWD) Will Use Its Cash WiselyEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • Feb 13Mediwound Ltd. Announces Positive Results in Head-To-Head Comparison of Escharex® Vs. Santyl® Within the Chronex Phase Ii Randomized Controlled StudyMediWound Ltd. announced the results of head-to-head comparison analyses of EscharEx, the Company’s lead asset in development for chronic wounds, to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers. SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States. Results from the previously disclosed Phase II study (ChronEx) which evaluated the safety and efficacy of EscharEx, demonstrated the superiority of EscahrEx vs. a gel vehicle (placebo) and non-surgical standard of care (NSSOC), in achieving complete debridement of non-viable tissue and promotion of granulation tissue (healthy, highly vascularized tissue). The secondary analyses announced assessed the incidence and time to complete debridement, complete granulation, and wound closure in patients treated with EscharEx (n=46) compared to a sub-group of patients who were treated with SANTYL (n=8).
분석 기사 • Feb 01Optimistic Investors Push MediWound Ltd. (NASDAQ:MDWD) Shares Up 26% But Growth Is LackingMediWound Ltd. ( NASDAQ:MDWD ) shares have continued their recent momentum with a 26% gain in the last month alone. The...
공시 • Jan 10Mediwound Announces That FDA Has Accepted for Review the Supplement to the Nexobrid BLA to Include Pediatric Patients with Severe Thermal BurnsMediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns. The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.
공시 • Dec 22Mediwound Ltd. Announces Publication of Escharex Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial LoadsMediWound Ltd. announced the publication of a peer-reviewed paper, titled "An Open-label, Proof of Concept Study, Assessing the Effects of Bromelain-Based Enzymatic Debridement on Biofilm and Microbial Loads in Patients with Venous Leg and Diabetic Foot Ulcers" in the December 2023 issue of WOUNDS Journal. The paper highlights results from a Phase II study, which explored the mechanism of action of EscharEx, a novel Bromelain based enzymatic debridement agent, in 12 patients with either venous leg ulcers (VLUs) or diabetic foot ulcers (DFUs). Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs. Key findings: 70% of the patients (7/10) that completed the study achieved complete debridement within a median time of 5.5 days. An average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. Together with the outcomes of previous Phase II study results, this study furthers the understanding of the effects of EscharEx. It demonstrates its effectiveness not only in enzymatic debridement and promotion of granulation tissue, but potentially also in reducing biofilm and bacterial load. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company's lead drug under development, EscharEx®?. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound's pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
분석 기사 • Dec 18MediWound Ltd.'s (NASDAQ:MDWD) 26% Share Price Surge Not Quite Adding UpMediWound Ltd. ( NASDAQ:MDWD ) shareholders would be excited to see that the share price has had a great month, posting...
Reported Earnings • Nov 24Third quarter 2023 earnings: EPS exceeds analyst expectationsThird quarter 2023 results: US$0.24 loss per share (improved from US$0.88 loss in 3Q 2022). Revenue: US$4.78m (down 18% from 3Q 2022). Net loss: US$2.20m (loss narrowed 48% from 3Q 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 40%. Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 31% per year, which means it is significantly lagging earnings.
Major Estimate Revision • Nov 23Consensus EPS estimates upgraded to US$0.75 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.34 to -US$0.753 per share. Revenue forecast steady at US$18.4m. Pharmaceuticals industry in the US expected to see average net income growth of 43% next year. Consensus price target of US$28.00 unchanged from last update. Share price rose 7.3% to US$8.70 over the past week.
공시 • Nov 22MediWound Ltd. Appoints Shmulik Hess as Chief Operating Officer and Chief Commercial Officer, Effective December 1, 2023MediWound Ltd. announced the appointment of Shmulik Hess, Ph.D. to the positions of Chief Operating Officer and Chief Commercial Officer effective as of December 1, 2023. Dr. Hess will lead and oversee all operational and commercial activities at MediWound. Dr. Hess has over two decades of extensive expertise in drug development and commercial operations in healthcare. He possesses a wealth of leadership experience in operational strategies, sales, and commercial facets within the global biopharma industry. Prior to joining MediWound, he served as Chief Executive Officer at Tabby Therapeutics, Enlivex Therapeutics and Valin Technologies. Formerly, Dr. Hess served as a global operations executive at SciGen Ltd. Dr. Hess is the inventor of multiple patents and author of numerous publications in peer reviewed scientific journals. He received his Ph.D. in Pharmaceutical Science from the Hebrew University, Israel and was a research fellow at Harvard-MIT Health Sciences and Technology (HST).
공시 • Nov 15MediWound Ltd. to Report Q3, 2023 Results on Nov 21, 2023MediWound Ltd. announced that they will report Q3, 2023 results at 9:30 AM, US Eastern Standard Time on Nov 21, 2023
공시 • Nov 14MediWound Ltd Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric PatientsMediWound Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently. This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages.
분석 기사 • Sep 29MediWound Ltd. (NASDAQ:MDWD) Stock Rockets 28% As Investors Are Less Pessimistic Than ExpectedMediWound Ltd. ( NASDAQ:MDWD ) shares have had a really impressive month, gaining 28% after a shaky period beforehand...
공시 • Sep 27MediWound Ltd. Secures Additional U.S. Department of Defense Funding to Advance NexoBrid Development for the U.S. ArmyMediWound Ltd. announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound additional funding to develop NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $6.5 million project budget will advance the development of a new, temperature stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.
New Risk • Sep 22New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 63% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.2m net loss in 3 years). Market cap is less than US$100m (US$86.8m market cap).
공시 • Sep 22MediWound Ltd. Announces U.S. Commercial Availability of NexoBrid®? for the Treatment of Severe Thermal Burns in AdultsMediWound Ltd. announced the U.S. commercial availability of NexoBrid®? (anacaulase-bcdb) for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis. Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue. NexoBrid selectively targets eschar while preserving viable tissue, enabling more rapid and precise eschar removal, which may reduce the need for subsequent skin grafting and lessen patient trauma. Each year, approximately 40,000 people are hospitalized in the U.S. for burn-related injuries, and of those patients, more than 30,000 of them require some level of eschar removal, representing a $300 million addressable market for NexoBrid in the U.S. NexoBrid can be applied in up to two applications of four hours each.
Board Change • Sep 01High number of new and inexperienced directorsThere are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. No highly experienced directors. Independent Director Vickie Driver is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
Reported Earnings • Aug 18Second quarter 2023 earnings: EPS and revenues exceed analyst expectationsSecond quarter 2023 results: EPS: US$0.099 (up from US$0.92 loss in 2Q 2022). Revenue: US$4.77m (up 2.2% from 2Q 2022). Net income: US$916.0k (up US$5.27m from 2Q 2022). Profit margin: 19% (up from net loss in 2Q 2022). The move to profitability was primarily driven by lower expenses. Revenue exceeded analyst estimates by 14%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 27% per year, which means it is performing significantly worse than earnings.
Price Target Changed • Aug 17Price target decreased by 20% to US$27.25Down from US$34.00, the current price target is an average from 4 analysts. New target price is 205% above last closing price of US$8.92. Stock is down 40% over the past year. The company is forecast to post a net loss per share of US$1.51 next year compared to a net loss per share of US$3.93 last year.
공시 • Aug 08MediWound Ltd. to Report Q2, 2023 Results on Aug 15, 2023MediWound Ltd. announced that they will report Q2, 2023 results on Aug 15, 2023
공시 • Aug 03MediWound Ltd. Announces Commercial Launch of NexoBrid®? in JapanMediWound Ltd. announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid®? in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan. NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns. The prospects are excellent for it becoming the new standard-of-care for serious and life-threatening burns, bringing significant benefits to providers and patients alike. Given long-term relationship with MediWound, have been anticipating this moment. NexoBrid is approved in over 40 countries, including in the United States and in the European Union where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA). 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% of total body surface area 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 less blood loss during eschar removal.
공시 • Jul 11Mediwound Ltd. Announces Positive Results in Its U.S. Phase I/Ii Study of Mw005 for the Treatment of Basal Cell CarcinomaMediWound Ltd. announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data show MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. The Phase I/II study is an open-label, multi-centered, randomized clinical trial designed to evaluate the safety and efficacyof MW005 in patients with BCC. All of the patients enrolled in the study had histologically confirmed superficial or nodular BCC. Enrolled patients received seven topical applications of MW005 once every other day for fourteen days. Eight weeks following the last treatment, all patients underwent a complete precisional biopsy. The excised specimen was subjected to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy assessments, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance. Fifteen patients were treated with MW005 and completed the study. Results showed MW005 to be safe and well-tolerated, with a high level of patient compliance. While the primary focus of the trial was on safety and tolerability, it is worth noting that based on clinical assessments, eleven out of fifteen patients achieved complete clearance of their BCCs; the majority of these patients also had histologically confirmed complete clearance. Data comprising clinical and histological outcomes, supported by extensive patient follow-up, will be featured at an upcoming scientific conference in 2023.These results corroborate the previous proof-of-concept study published by Prof. Rosenberg et al (Basal CellCarcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report;TODJ-15-39 [1], 2021), where seven BCC tumors treated with MW005 were completely removed based on clinicalassessment, and none reoccurred over the subsequent 24 months.
공시 • Jul 04MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study DesignMediWound Ltd. announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization. The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies. In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each. Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid®, which has been approved for debridement of thermal burns in the U.S. and Europe.
Major Estimate Revision • Jun 04Consensus revenue estimates fall by 12%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$20.5m to US$18.0m. Forecast losses increased from -US$1.34 to -US$1.51 per share. Pharmaceuticals industry in the US expected to see average net income decline 18% next year. Consensus price target broadly unchanged at US$34.00. Share price fell 8.3% to US$8.91 over the past week.
Reported Earnings • May 31First quarter 2023 earnings: EPS and revenues miss analyst expectationsFirst quarter 2023 results: US$0.44 loss per share. Revenue: US$3.80m (down 14% from 1Q 2022). Net loss: US$3.69m (loss widened 2.9% from 1Q 2022). Revenue missed analyst estimates by 26%. Earnings per share (EPS) also missed analyst estimates by 144%. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 7.2% growth forecast for the Pharmaceuticals industry in the US.
공시 • May 13MediWound Ltd. to Report Q1, 2023 Results on May 30, 2023MediWound Ltd. announced that they will report Q1, 2023 results on May 30, 2023
Reported Earnings • Mar 17Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFull year 2022 results: US$3.93 loss per share (further deteriorated from US$3.48 loss in FY 2021). Revenue: US$26.5m (up 12% from FY 2021). Net loss: US$19.6m (loss widened 45% from FY 2021). Revenue exceeded analyst estimates by 23%. Earnings per share (EPS) missed analyst estimates by 81%. Revenue is forecast to grow 31% p.a. on average during the next 3 years, compared to a 5.0% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has fallen by 45% per year but the company’s share price has only fallen by 1% per year, which means it has not declined as severely as earnings.
Major Estimate Revision • Jan 03Consensus estimates of losses per share improve by 10%The consensus outlook for earnings per share (EPS) in 2022 has improved. 2022 revenue forecast increased from US$19.6m to US$21.1m. EPS estimate increased from -US$3.36 per share to -US$3.02 per share. Pharmaceuticals industry in the US expected to see average net income growth of 6.9% next year. Consensus price target down from US$43.50 to US$37.00. Share price rose 15% to US$13.29 over the past week.
Price Target Changed • Dec 23Price target decreased to US$43.50Down from US$49.70, the current price target is an average from 5 analysts. New target price is 278% above last closing price of US$11.50. Stock is down 27% over the past year. The company is forecast to post a net loss per share of US$3.36 next year compared to a net loss per share of US$3.48 last year.
Reported Earnings • Nov 16Third quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behindThird quarter 2022 results: US$0.13 loss per share (further deteriorated from US$0.12 loss in 3Q 2021). Revenue: US$5.80m (down 8.9% from 3Q 2021). Net loss: US$4.20m (loss widened 26% from 3Q 2021). Revenue exceeded analyst estimates by 26%. Earnings per share (EPS) missed analyst estimates by 33%. Revenue is forecast to grow 46% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 44 percentage points per year, which is a significant difference in performance.
Board Change • Nov 16High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Board Change • Nov 02High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Board Change • Nov 02High number of new directorsThere are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
Price Target Changed • Oct 15Price target increased to US$7.20Up from US$6.00, the current price target is an average from 5 analysts. New target price is 445% above last closing price of US$1.32. Stock is down 61% over the past year. The company is forecast to post a net loss per share of US$0.43 next year compared to a net loss per share of US$0.50 last year.
Seeking Alpha • Sep 20MediWound's NexoBrid for thermal burns in children gets EMA reviewThe European Medicines Agency (EMA) validated for review MediWound's (NASDAQ:MDWD) application for expanded use of NexoBrid in children aged newborn through 18 years of age for removal of eschar (dead tissue) with deep partial-and full-thickness thermal burn wounds. The submission is backed by interim data from a global, phase 3 trial (CIDS - Children Innovative Debridement Study), EU phase 3 study (MW2004-11-02) and phase 2 studies conducted during the clinical development of NexoBrid. NexoBrid is also under review in the U.S. for use in adults.
Major Estimate Revision • Aug 16Consensus revenue estimates fall by 14%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$21.3m to US$18.4m. Forecast losses increased from -US$0.37 to -US$0.44 per share. Pharmaceuticals industry in the US expected to see average net income decline 3.6% next year. Consensus price target down from US$6.25 to US$6.00. Share price rose 27% to US$2.24 over the past week.
Reported Earnings • Aug 11Second quarter 2022 earnings: EPS and revenues miss analyst expectationsSecond quarter 2022 results: US$0.13 loss per share (down from US$0.12 loss in 2Q 2021). Revenue: US$4.67m (down 23% from 2Q 2021). Net loss: US$4.35m (loss widened 36% from 2Q 2021). Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 34%. Over the next year, revenue is forecast to grow 13%, compared to a 16% growth forecast for the industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 71 percentage points per year, which is a significant difference in performance.
분석 기사 • Aug 11Need To Know: Analysts Just Made A Substantial Cut To Their MediWound Ltd. (NASDAQ:MDWD) EstimatesToday is shaping up negative for MediWound Ltd. ( NASDAQ:MDWD ) shareholders, with the analysts delivering a...
Price Target Changed • Aug 09Price target increased to US$6.90Up from US$6.25, the current price target is an average from 6 analysts. New target price is 290% above last closing price of US$1.77. Stock is down 53% over the past year. The company is forecast to post a net loss per share of US$0.37 next year compared to a net loss per share of US$0.50 last year.
Seeking Alpha • Aug 09MediWound GAAP EPS of -$0.13 misses by $0.03, revenue of $4.67M misses by $0.61MMediWound press release (NASDAQ:MDWD): Q2 GAAP EPS of -$0.13 misses by $0.03. Revenue of $4.67M (-22.8% Y/Y) misses by $0.61M.
Seeking Alpha • Aug 03MediWound refiling for NexoBrid to treat severe thermal burns gets FDA reviewThe U.S. Food and Drug Administration (FDA) accepted for review MediWound's (NASDAQ:MDWD) re-submitted biologics license application (BLA) seeking approval of NexoBrid for eschar (dead tissue) removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA is expected to make a decision by Jan. 1, 2023. MediWound said the the BLA re-filing adds to manufacturing data, preclinical and clinical studies — including a U.S. phase 3 study — previously submitted. Vericel (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid, according to MediWound. MediWound noted that NexoBrid development has been supported in part with federal funding from U.S. Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services.
Seeking Alpha • Jul 07MediWound adds 13% after favorable data for ulcer candidateIsraeli biopharma MediWound (NASDAQ:MDWD) climbed ~13% in the pre-market Thursday after the company announced positive data from a Phase 2 trial designed to evaluate its wound candidate EscharEx as a therapy for the debridement of lower leg ulcers. The U.S.-based open-label, single-arm trial involved 12 patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). 70% of patients achieved complete debridement during the treatment course after about eight applications of EscharEx, a treatment designed for the outpatient setting. There was complete debridement in about 3.9 applications on average. After a two-week follow up period, data indicated an average of 35% reduction of wound size. “The data from our pharmacology study corroborates the results of our previous Phase 2 studies, and clearly supports EscharEx as a potential rapid and effective, non-surgical debriding agent,” MediWound (MDWD) Chief Executive Ofer Gonen said. The latest trial results for EscharEx come only days after Gonen assumed duties as the company’s new CEO.
Seeking Alpha • Jun 30MediWound taps Tzvi Palash as COOTzvi Palash has been appointed as COO at biopharmaceutical company MediWound (NASDAQ:MDWD). Palash brings over 35 years of experience, having previously served at Enlivex, where he led the design and construction of the new cGMP manufacturing facility. At MediWound, Palash will be responsible for leading all operational activities.
분석 기사 • Jun 24Is MediWound (NASDAQ:MDWD) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Reported Earnings • May 18First quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFirst quarter 2022 results: US$0.13 loss per share (down from US$0.10 loss in 1Q 2021). Revenue: US$4.41m (down 25% from 1Q 2021). Net loss: US$3.59m (loss widened 26% from 1Q 2021). Revenue exceeded analyst estimates by 2.6%. Earnings per share (EPS) missed analyst estimates by 4.3%. Over the next year, revenue is forecast to grow 6.0%, compared to a 13% growth forecast for the industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 51 percentage points per year, which is a significant difference in performance.
Price Target Changed • Apr 27Price target decreased to US$6.25Down from US$6.92, the current price target is an average from 6 analysts. New target price is 188% above last closing price of US$2.17. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.50 last year.
Major Estimate Revision • Mar 24Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$25.7m to US$20.9m. EPS estimate increased from -US$0.40 to -US$0.34 per share. Pharmaceuticals industry in the US expected to see average net income growth of 14% next year. Consensus price target down from US$6.92 to US$6.25. Share price was steady at US$1.94 over the past week.
Price Target Changed • Mar 22Price target decreased to US$6.25Down from US$6.92, the current price target is an average from 6 analysts. New target price is 224% above last closing price of US$1.93. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$0.34 next year compared to a net loss per share of US$0.50 last year.
Reported Earnings • Mar 18Full year 2021 earnings: EPS exceeds analyst expectationsFull year 2021 results: US$0.50 loss per share (down from US$0.34 loss in FY 2020). Revenue: US$23.8m (up 9.2% from FY 2020). Net loss: US$13.6m (loss widened 46% from FY 2020). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.0%. Over the next year, revenue is forecast to grow 6.1%, compared to a 17% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 37 percentage points per year, which is a significant difference in performance.
