MediWound Ltd. - MDWD STOCK NEWS

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.

MediWound Ltd. (Nasdaq: MDWD) announced the publication of a peer-reviewed study on its wound debriding product, EscharEx, in the Wound Repair and Regeneration Journal. The phase 2 trial evaluated 73 patients with chronic wounds, demonstrating that EscharEx achieved a significantly higher incidence of complete debridement compared to a hydrogel vehicle, thereby meeting the study's primary endpoint. An interim assessment of the ongoing U.S. phase 2 adaptive design study for venous leg ulcers is expected by the end of July 2021. CEO Sharon Malka stated EscharEx shows potential to enhance chronic wound management.

MediWound Ltd. (Nasdaq: MDWD) announced that the FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for NexoBrid, intended for eschar removal in burn patients. The FDA noted issues in the Chemistry, Manufacturing, and Controls (CMC) section, requiring further information and facility inspections that were delayed due to COVID-19. Despite the setback, MediWound remains committed to collaborating with the FDA for a potential approval, highlighting the clinical data's strength and the therapy's importance for burn victims.

MediWound Ltd. (Nasdaq: MDWD) announced the completion of the patient enrollment target for its U.S. Phase 2 study of EscharEx, a treatment for venous leg ulcers (VLUs). An interim assessment for futility analysis is expected by the end of July 2021, with a total of 120 patients to be enrolled by year-end. The company noted a significant market opportunity exceeding a billion dollars annually for EscharEx. Additionally, a separate Phase 2 open-label study is underway, focusing on diabetic foot ulcers and the pharmacological effects of EscharEx.

MediWound Ltd. (Nasdaq: MDWD) announced a peer-reviewed publication demonstrating preliminary proof-of-concept for MW005, a treatment for basal cell carcinoma (BCC). The study reported successful destruction of six BCC tumors using proteolytic enzymes enriched in bromelain. MediWound plans to initiate a Phase I/II clinical study for MW005 in June 2021, with data expected by year's end. BCC is the most common skin cancer type, with about 4.3 million cases diagnosed annually in the U.S. The company views MW005 as a potential solution for an unmet medical need in non-melanoma skin cancers.