Welcome to our dedicated page for Mediwound news (Ticker: MDWD), a resource for investors and traders seeking the latest updates and insights on Mediwound stock.
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on enzymatic, non-surgical therapies for tissue repair, and its news flow reflects this specialization. Company announcements frequently highlight clinical progress for its late-stage investigational product EscharEx®, including updates on the global VALUE Phase III trial in venous leg ulcers and planned studies in diabetic foot ulcers and pressure ulcers. Investors and healthcare professionals can follow how these trials evolve, along with peer-reviewed publications that analyze wound bed preparation and healing outcomes.
News about MediWound also covers the commercial and clinical use of its FDA-approved biologic NexoBrid®, indicated for enzymatic removal of eschar in thermal burns. Recent releases have described new clinical data on NexoBrid in traumatic tattoos from abrasion and blast injuries, as well as its role in scientific presentations at major burn congresses. Regulatory milestones, such as marketing approval in Australia and expansion to 45 countries, feature prominently in the company’s updates.
Operational and financial developments are another key theme in MDWD news. MediWound reports on expansion and commissioning of its GMP manufacturing facility in Yavne, Israel, designed to increase NexoBrid production capacity, and on BARDA- and U.S. Department of Defense-funded projects, including work on a room temperature-stable formulation. Quarterly and annual financial results, equity financings under shelf registration statements, and revenue guidance are detailed in regular press releases and associated conference calls.
For readers tracking MDWD, this news stream offers insight into clinical trial milestones, regulatory decisions, manufacturing readiness, government-supported programs, and financial performance. Bookmark this page to follow ongoing developments that shape MediWound’s burn and chronic wound therapy portfolio.
MediWound Ltd. (Nasdaq: MDWD) announced an expansion of its contract with the Biomedical Advanced Research and Development Authority (BARDA), receiving an additional $9 million for NexoBrid's BLA resubmission and expanded access treatment protocol. This funding raises the total non-dilutive funding from BARDA to $211 million. NexoBrid, a product designed for burn treatment, has been under BARDA's support since 2015. The company anticipates further collaboration with BARDA and plans to submit its BLA mid-2022 to enhance U.S. healthcare preparedness.
MediWound announced positive topline results from its U.S. Phase 2 clinical study of EscharEx for treating venous leg ulcers. The study included 120 patients and met its primary endpoint, showing a statistically significant higher incidence of complete debridement with EscharEx (63%) compared to the gel vehicle (30%) with a p-value of 0.004. Safety reviews indicated no concerns. The company plans to submit for an end-of-Phase 2 meeting with the FDA in late 2022, aiming for Phase 3 trials. This highlights EscharEx's potential in a billion-dollar chronic wound care market.
MediWound Ltd. (Nasdaq: MDWD) announced positive initial data from its phase 2 study of EscharEx, a novel enzymatic debridement therapy for chronic wounds. The study involved seven patients and demonstrated safety and effective debridement of diabetic foot ulcers and venous leg ulcers. Results indicated a significant reduction in wound biofilm and bacterial burden. The full data set is expected to be shared in the first half of 2022. EscharEx aims to improve current wound care treatments with its efficient bioactive approach.
MediWound Ltd. (Nasdaq: MDWD) announced the completion of patient enrollment in its U.S. Phase 2 clinical study for EscharEx®, a treatment for venous leg ulcers (VLUs). The trial, involving 120 patients across 20 sites, compares EscharEx to a gel vehicle and non-surgical standard-of-care treatments. Following a positive interim assessment, topline data is expected in Q1 2022. This represents a significant step in addressing the chronic wound care market, valued over $1 billion annually.
MediWound Ltd. (Nasdaq: MDWD) announced receiving positive scientific advice from the EMA's CHMP regarding the pediatric label extension for NexoBrid, anticipated for submission in the first half of 2022. This follows significant outcomes from the pivotal Phase 3 CIDS study, which demonstrated effective treatment for thermal burns in children, achieving its primary endpoints with a strong safety profile. NexoBrid aims to provide a non-surgical treatment option, expanding its market presence in Europe, and potentially improving treatment standards for pediatric patients.
MediWound Ltd. (Nasdaq: MDWD) reported Q3 2021 revenues of $6.4 million, a 4% decline from Q3 2020. Year-to-date revenues rose by 21% to $18.3 million. The company maintains $13.9 million in cash and short-term investments as of September 30, 2021. A regulatory path for the resubmission of NexoBrid's Biologics License Application (BLA) is established, targeted for mid-2022. The EscharEx Phase 2 program's top-line results are now expected in Q1 2022. Notably, net loss for Q3 2021 was $3.3 million, or $0.12 per share.
MediWound Ltd. (Nasdaq: MDWD) will release its financial results for Q3 2021 on November 16, 2021, at 7:00 am ET. A conference call will follow at 8:30 am ET to discuss these results and address questions. MediWound focuses on biotherapeutic solutions for tissue repair, with products like NexoBrid® for burn treatment and EscharEx for chronic wounds in advanced development stages. The company aims to improve patient care through innovative therapies.
MediWound Ltd. (Nasdaq: MDWD) announced positive results from a peer-reviewed study published in the Journal of Wound Care, demonstrating that EscharEx is superior in removing chronic wound eschar compared to a commercial collagenase agent. Conducted using a novel porcine model, the study found that EscharEx achieved over 95% eschar removal within ten applications, while collagenase did not. This efficacy supports the ongoing U.S. Phase 2 study for treating venous leg ulcers, which is expected to report results in the first half of next year.
MediWound Ltd. (Nasdaq: MDWD), a biopharmaceutical company specializing in advanced therapeutic solutions for tissue repair, announced presentations at key investor conferences in September 2021. The company will participate in the 2021 Wells Fargo Virtual Healthcare Conference on September 9 at 8:00 a.m. ET and the H.C. Wainwright 23rd Annual Global Investment Conference with an on-demand presentation available starting September 13. The company focuses on innovative products like NexoBrid and EscharEx for burn care and wound management.
MediWound Ltd. (MDWD) reported second-quarter revenues of $6.1 million, marking a significant 50% increase year-over-year. The company maintained $17.2 million in cash and short-term investments. A positive interim assessment for the EscharEx Phase II clinical study was announced, with full enrollment expected by year-end 2021. Despite receiving a Complete Response Letter from the FDA for the NexoBrid BLA, positive results from the pediatric study reinforce its safety and efficacy. The first half of 2021 showed a 41% revenue increase to $11.9 million.