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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 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.
MediWound Ltd. (MDWD) will release its financial results for Q2 2021 on Aug. 10, 2021, at 7:00 am ET. A conference call is scheduled for the same day at 8:30 am ET to discuss these results and provide a corporate update. MediWound specializes in bio-therapeutic solutions for tissue repair and regeneration, notably NexoBrid® for burn treatment, which is marketed in the EU and pending in the U.S. Additionally, EscharEx for chronic wound care is in advanced development with promising trial results.
MediWound Ltd. (MDWD) announced a positive interim recommendation from the Independent Data Monitoring Committee (IDMC) regarding its EscharEx® U.S. phase 2 study for treating venous leg ulcers. The IDMC confirmed that the original enrollment target of 120 patients remains sufficient for statistical power, with no safety concerns reported. Full enrollment is expected by the end of 2021, and data readout is anticipated in the first half of 2022. EscharEx is designed to be a non-surgical therapy for chronic wound management, with potential to replace current standard care.
MediWound Ltd. (Nasdaq: MDWD) has initiated a phase I/II clinical study of MW005 to treat low-risk Basal Cell Carcinoma (BCC). This open-label, randomized trial aims to assess safety, tolerability, and preliminary efficacy. Up to 32 patients will participate at three U.S. clinical centers. Concurrently, a phase II trial at Soroka Medical Center will study MW005 in non-melanoma skin cancers. Results from both studies are expected by the end of 2021. BCC is the most common skin cancer in the U.S., with approximately 4.3 million cases annually.
MediWound Ltd. (Nasdaq: MDWD) announced positive topline results from its pivotal phase 3 pediatric study on NexoBrid for treating severe thermal burns in children. The study met all three primary endpoints with high statistical significance, demonstrating a substantially shorter time to complete eschar removal (0.99 days vs. 5.99 days for SOC) and significantly lower wound area needing surgical excision (1.5% vs. 48.1%). NexoBrid was well-tolerated, showing no adverse effects on wound healing. These findings reinforce NexoBrid's potential as a non-surgical treatment option for pediatric patients.
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