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 biopharmaceutical innovator developing enzymatic therapeutics for non-surgical wound care. This page provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic developments.
Access consolidated information about NexoBrid adoption, EscharEx clinical trials, and pipeline progress. Stay informed about financial results, partnership announcements, and market expansion initiatives directly impacting MediWound's position in wound care innovation.
Key updates include FDA/EMA regulatory decisions, burn treatment protocols, chronic wound therapy breakthroughs, and peer-reviewed research findings. All content is verified through primary sources to ensure accuracy for investment and clinical decision-making.
Bookmark this page for streamlined access to MediWound's latest developments. Combine our updates with SEC filings and earnings call transcripts for comprehensive analysis of this enzymatic therapeutics leader.
MediWound (MDWD) has launched VALUE, a global Phase III pivotal trial for EscharEx® in treating venous leg ulcers (VLUs). The trial will evaluate the drug's efficacy and safety across 40 sites in the U.S. and Europe, enrolling 216 patients in a randomized, double-blind, placebo-controlled study.
The study will assess EscharEx's ability to achieve complete debridement and wound closure. Patients will receive up to eight daily applications over two weeks, followed by ten weeks of wound management. An interim analysis is expected in mid-2026 after 65% of patients complete treatment.
MediWound has established collaborations with Solventum, Mölnlycke, and MIMEDX to support the trial. The company also plans to initiate a head-to-head Phase II study comparing EscharEx to collagenase in 2025, and a Phase II/III trial for diabetic foot ulcers in 2026.
MediWound (Nasdaq: MDWD), a pioneer in enzymatic therapeutics for tissue repair, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. CEO Ofer Gonen will engage in a fireside chat on February 12, 2025, at 8:00 AM ET, moderated by Francois Brisebois, Managing Director and Senior Biotechnology Research Analyst at Oppenheimer.
The virtual event will be accessible through registration, and a webcast link will be available on MediWound's website under the Events & Presentations section. The management team will also conduct one-on-one meetings with investors during the conference, which can be arranged through Oppenheimer representatives.
MediWound (MDWD) announced a virtual Key Opinion Leader (KOL) event scheduled for January 8, 2025, at 10:00 AM ET. The event will focus on EscharEx®, their biologic drug in late-stage clinical development for chronic wound debridement, specifically discussing the upcoming Phase III VALUE study in venous leg ulcers (VLUs) and its commercial potential.
The event will feature three distinguished clinical experts from prestigious institutions who will discuss compelling Phase II study results, the Phase III VALUE study, unmet needs in VLUs and diabetic foot ulcers (DFUs) treatment, and EscharEx's competitive advantages. A Q&A session with the experts and MediWound's leadership team will follow the presentations.
MediWound reported Q3 2024 financial results with revenue of $4.4 million, down from $4.8 million in Q3 2023. The company achieved FDA approval for NexoBrid pediatric use and plans to submit an IND for EscharEx Phase 3 study by year-end. Notable developments include a $25 million PIPE financing and €16.25 million EIC funding. The company's new manufacturing facility is under commissioning, expected to increase capacity sixfold by end of 2025. Updated 2024 revenue guidance is $20 million, reduced from $24 million. Q3 net loss widened to $10.3 million compared to $2.2 million in Q3 2023, primarily due to warrant revaluation expenses.
MediWound announced it will release its third quarter 2024 financial results on November 26, 2024. The results will cover the period ending September 30, 2024. Following the release, the company's management will host a conference call and live webcast at 8:30 a.m. Eastern Time to discuss the financial results and provide corporate updates. The call can be accessed using the following numbers: Toll-Free: 1-833-630-1956, Israel: 1-80-921-2373, International: 1-412-317-1837. A replay of the webcast will be available on the Investors section of the MediWound website.
MediWound (Nasdaq: MDWD) has announced the initiation of a Phase II clinical study comparing EscharEx® to collagenase ointment for treating venous leg ulcers (VLUs). The study, set to begin in 2025, will run alongside the company's Phase III trial and aims to support the Biologics License Application (BLA) for EscharEx while strengthening MediWound's commercialization strategy.
The randomized study will enroll 45 patients across multiple sites in the U.S. and Europe, evaluating safety endpoints and exploratory efficacy measures. MediWound has secured R&D collaborations with Solventum and Mölnlycke Health Care to provide compression systems and wound care products, ensuring consistency and optimal patient outcomes across study arms.
MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Ofer Gonen will engage in a fireside chat on Wednesday, October 16, 2024, at 9:30 a.m. ET. The discussion will be hosted by Michael Okunewitch, Senior Biotechnology Analyst at Maxim.
Interested parties can register to attend the virtual fireside chat through the provided link. Additionally, the MediWound management team will be available for one-on-one meetings during the summit. Investors wishing to schedule a meeting are advised to contact their Maxim representative.
MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. CEO Ofer Gonen will engage in a fireside chat on September 10, 2024, at 3:30 p.m. ET.
The discussion, hosted by Swayampakula Ramakanth, Managing Director, Senior Equity Research, will be available via live webcast. Investors and interested parties can access the webcast through a provided link or on MediWound's website under the Events & Presentations page in the Investors section.
This presentation offers an opportunity for investors to gain insights into MediWound's latest developments and future prospects in the field of next-generation enzymatic therapeutics for tissue repair.
MediWound (Nasdaq: MDWD) has announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for use in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. This approval expands NexoBrid's use to all age groups in the U.S., aligning with its approvals in the European Union and Japan.
The approval was supported by the results of the global Phase III Children Innovation Debridement Study (CIDS), funded by BARDA, as well as additional pediatric data from Phase III and Phase II studies. This milestone is significant as pediatric burn victims represent over 30% of the total burn population, and NexoBrid offers a non-surgical alternative to the current traumatic standard of care.
MediWound (MDWD) reported Q2 2024 financial results and provided a company update. Key highlights include:
1. Completed construction of new NexoBrid® manufacturing facility, increasing capacity sixfold.
2. Secured €16.25 million EIC funding to expand EscharEx® development for diabetic foot ulcers.
3. Raised $25 million in strategic investment led by Mölnlycke Health Care.
4. Q2 revenue increased to $5.1 million, up from $4.8 million in Q2 2023.
5. Net loss of $6.3 million in Q2 2024, compared to net profit of $0.9 million in Q2 2023.
6. Cash position of $29.7 million as of June 30, 2024.
7. NexoBrid U.S. launch gaining momentum with 70+ burn centers submitting to P&T committees.
8. EscharEx Phase III study for venous leg ulcers to begin in H2 2024.
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