Welcome to our dedicated page for MediWound Ltd. news (Ticker: MDWD), a resource for investors and traders seeking the latest updates and insights on MediWound Ltd. stock.
MediWound Ltd. (Nasdaq: MDWD) is an integrated biopharmaceutical company focused on developing, manufacturing, and commercializing novel therapeutic products. The company's mission is to address unmet medical needs in the fields of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders, and other medical conditions. MediWound leverages its patented proteolytic enzyme technology to create innovative and effective treatments.
NexoBrid®, MediWound's flagship product, has received marketing authorization from multiple health agencies, including the European Medicines Agency, as well as health ministries in Israel and Argentina. This innovative biopharmaceutical product is designed for the non-surgical removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Clinical trials have demonstrated NexoBrid's capability to rapidly and effectively debride eschar without harming viable tissue.
MediWound's pipeline includes several promising products. EscharEx®, another key product, is a topical biological drug being developed for debridement of chronic wounds. This product has shown significant potential in clinical trials, suggesting it can outperform traditional enzymatic debridement methods and improve patient outcomes. Additionally, MW005 is under development for the treatment of non-melanoma skin cancers, offering a new hope for patients with basal cell carcinoma.
The company has established valuable partnerships and research collaborations with industry leaders such as 3M, Mölnlycke, and MIMEDX. These collaborations aim to further validate and enhance MediWound's product pipeline. Recent achievements include substantial governmental grants, expanded indications for NexoBrid, and successful market entries in new regions.
Financially, MediWound is on solid ground. As of December 31, 2023, the company reported a cash, restricted cash, and investments balance of $42.1 million, compared to $34.1 million at the end of 2022. In the first quarter of 2023, MediWound raised $27.5 million through a registered direct offering, using $17.1 million to support its activities. The company expects its existing financial resources to be sufficient to reach profitability.
MediWound's commitment to improving patient care through innovative enzymatic therapeutics positions it as a significant player in the biopharmaceutical industry. With a strong pipeline and robust financial health, the company aims to continue delivering life-saving treatments and expanding its market presence.
For more information, visit www.mediwound.com and follow the company on LinkedIn and X.
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.
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
FAQ
What is the current stock price of MediWound Ltd. (MDWD)?
What is the market cap of MediWound Ltd. (MDWD)?
What is MediWound Ltd.'s core business?
What is NexoBrid®?
What are the benefits of EscharEx®?
Who are MediWound's industry partners?
What recent achievements has MediWound accomplished?
What is the financial condition of MediWound Ltd.?
What are MediWound's future plans?
How does NexoBrid® work?
What makes MediWound's enzymatic technology unique?
Where can I find more information about MediWound Ltd.?
