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 the FDA approval of NexoBrid (anacaulase-bcdb), a non-surgical treatment for eschar removal in adults with deep partial- and full-thickness thermal burns. This approval triggers a $7.5 million milestone payment from Vericel Corporation, which will exclusively commercialize NexoBrid in North America. Anticipated to launch in Q2 2023, NexoBrid is already approved in 43 countries and is expected to become a new standard of care in burn treatment, backed by significant clinical study results demonstrating its efficacy and safety.
MediWound Ltd. (Nasdaq: MDWD) has announced that its partner, Kaken Pharmaceutical Co., Ltd., received marketing approval for NexoBrid in Japan, applicable to both pediatric and adult populations. NexoBrid is a treatment for deep-partial and full-thickness thermal burns, approved under orphan drug designation. Kaken is set to launch NexoBrid in summer 2023, furthering MediWound's global strategy for commercialization. NexoBrid is already approved in 43 countries and has a PDUFA date with the FDA set for January 1, 2023.
MediWound Ltd. (NASDAQ: MDWD) announced marketing approval for NexoBrid in Switzerland, with a launch planned for Q1 2023. The company has partnered with Triskel Integrated Services for distribution, which also covers France, where NexoBrid is expected to launch in Q3 2023. NexoBrid, approved in 42 countries, is designed for non-surgical eschar removal in burn patients. MediWound anticipates reimbursement approval in Switzerland and aims to expand into pediatric use, pending a decision from the European Commission in Q1 2023.
MediWound Ltd. (Nasdaq: MDWD) announced positive results from its Phase I/II study of MW005 for treating low-risk Basal Cell Carcinoma (BCC), showing it to be safe, well-tolerated, and effective. Patients achieved complete clinical and histological clearance of target lesions. The study involved 11 patients receiving seven topical applications of MW005, with follow-ups confirming clearance. MediWound plans to continue patient enrollment and optimize dosing regimens. CEO Ofer Gonen highlighted MW005's potential as a non-surgical solution for BCC amidst rising cases, estimated at 4.3 million annually in the U.S.
MediWound Ltd. (NASDAQ: MDWD) has announced the marketing approval of NexoBrid in India, following an exclusive agreement with Bharat Serums and Vaccines Limited (BSV) to distribute the product for treating severe burns. NexoBrid, which enzymatically removes burn tissue, is expected to be marketed by BSV in the first half of 2023. This approval responds to a significant medical need, as India reports around seven million burn injuries annually, with high mortality rates. NexoBrid is already approved in 42 countries and has pending registration with the FDA.
MediWound Ltd. (Nasdaq: MDWD) announced a 1-for-7 reverse share split, effective December 20, 2022, after receiving shareholder approval on November 28, 2022. The split aims to enhance shareholder value and attract institutional investors by increasing the share price. Following the split, every seven shares will convert into one, with no fractional shares issued. The authorized share count will decrease from 90 million to approximately 12.86 million, while the par value will rise from NIS 0.01 to NIS 0.07. The company continues to develop its therapeutic solutions for tissue repair and regeneration.
MediWound Ltd. (NASDAQ: MDWD) announced significant financial developments, raising $30.5 million in gross proceeds to extend cash runway through 2025. The FDA's review of NexoBrid is progressing with a PDUFA date set for January 1, 2023, anticipated to generate substantial revenues upon approval. The company is also gearing up for a Phase 3 clinical study of EscharEx targeting a billion-dollar market opportunity. Despite a decrease in revenues to $5.8 million in Q3 2022 from $6.4 million in Q3 2021, MediWound holds a strong cash position of $17.6 million.
MediWound Ltd. (NASDAQ: MDWD) announced the publication of a paper in the November 2022 issue of Podiatry Management, detailing the efficacy of its product EscharEx® for debridement of Diabetic Foot Ulcers (DFUs). The findings indicate that over 50% of patients achieve complete debridement within a week. EscharEx outperformed hydrogel treatments and may represent a shift in wound care management. A meeting with the FDA is planned for Q4 2022 to discuss Phase 3 study design, highlighting the product's potential significance for chronic wound care.
MediWound Ltd. (Nasdaq: MDWD) announced a conference call and webcast on November 15, 2022, at 8:30 am Eastern Time to discuss its Q3 2022 financial results. The call will provide corporate updates and answer investor questions. MediWound focuses on biotherapeutic solutions for tissue repair, with products like NexoBrid for burn care and EscharEx for chronic wounds. The company is also developing MW005 for non-melanoma skin cancers, with results from a Phase I/II study indicating safety and efficacy.
MediWound Ltd. (NASDAQ: MDWD) has established a Strategic Advisory Board (SAB) comprised of industry leaders to guide its strategic initiatives. The board includes professionals such as John C. Lantis, Samuel Moed, and Eric Shem-Tov, who will bring extensive expertise to the company's efforts, particularly as EscharEx moves into Phase 3 studies and NexoBrid prepares for U.S. approval. This assembly aims to optimize MediWound’s product potential, reflecting the company’s commitment to advancing biotherapeutic solutions for tissue regeneration.