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 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.
MediWound (Nasdaq: MDWD) announced positive results from the U.S. NexoBrid® Expanded Access Protocol (NEXT). The study, conducted at 29 burn centers, involved 239 patients with deep partial and full-thickness thermal burns. Key findings include:
- 94.9% of adults and 100% of children achieved complete debridement
- Only 4.2% of adults required surgical excision after NexoBrid treatment
- Time to complete eschar removal was less than one day for all patients
- Median time to wound closure was 22 days for adults and 28 days for children
- Median hospitalization duration was 10 days for both adults and children
The results confirm NexoBrid's safety and efficacy in eschar removal, significantly reducing surgical procedures for burn patients. The safety data was consistent with NexoBrid's established profile, with no new concerns identified.
MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced it will release its Q2 2024 financial results on August 14, 2024. The company will host a conference call and webcast at 8:30 am Eastern Time on the same day to discuss the results and provide corporate updates.
Investors and interested parties can join the call using the following details:
- Toll-Free: 1-833-630-1956
- Israel: 1-80-921-2373
- International: 1-412-317-1837
MediWound (Nasdaq: MDWD) has announced the publication of its Phase II ChronEx study results for EscharEx® in treating Venous Leg Ulcers (VLU) in THE LANCET's eClinicalMedicine. The study, conducted across 20 medical centers in the US, Europe, and Israel, demonstrated EscharEx's superiority over non-surgical standard of care in debridement and promoting healthy granulation tissue.
Key findings include:
- 63.0% complete debridement rate for EscharEx vs. 30.2% for placebo and 13.3% for non-surgical standard of care
- Median time to complete debridement: 9 days for EscharEx vs. 63 days for placebo
- 50.0% incidence of complete cover with healthy granulation tissue for EscharEx vs. 25.6% for placebo
- Comparable safety profile to placebo and non-surgical standard of care