Mediwound Stock Price, News & Analysis

MediWound Ltd. (MDWD) announced that the FDA accepted its re-submitted Biologics License Application (BLA) for NexoBrid for eschar removal in adults with severe thermal burns. The FDA has set a PDUFA target date of January 1, 2023. NexoBrid has proven effective in clinical trials, meeting all primary and secondary endpoints, and is already approved in the EU and other regions. The development has received support from BARDA, enhancing its potential for U.S. market introduction. This advancement brings MediWound closer to commercializing NexoBrid in the U.S.

MediWound Ltd. (Nasdaq: MDWD) will announce its second-quarter financial results for the period ending June 30, 2022, on August 9, 2022, at 8:30 AM ET. Following the announcement, a conference call will be held to discuss these results and provide corporate updates. The company focuses on developing biotherapeutic solutions for tissue repair, including NexoBrid for burn care and EscharEx for chronic wound debridement. The upcoming call will allow investors to gain insights into financial performance and business operations.

MediWound Ltd. (Nasdaq: MDWD) announced positive initial results from its Phase I/II study of MW005 for low-risk Basal Cell Carcinoma (BCC). The data indicates that MW005 is safe, well-tolerated, and effective, with most patients achieving complete histological clearance of target lesions after treatment. The study involved eleven patients receiving seven topical applications over eight weeks. CEO Ofer Gonen highlighted the significant market potential for non-surgical BCC treatments. Final data is expected in the second half of 2022, further validating MW005's clinical efficacy.

MediWound Ltd. (Nasdaq: MDWD) announced an upcoming oral presentation at the Advanced Wound Care Summit on July 13-14, 2022, in Boston, MA. Dr. Robert Snyder will present an analysis titled “Market Landscape Analysis & EscharEx Market Potential” at 3:00 pm ET on July 13. The presentation will cover the wound care market and the potential of EscharEx, a therapy for chronic wound debridement currently in advanced clinical development. EscharEx has shown safety and efficacy in Phase 2 trials, and a meeting with the FDA is targeted for the second half of 2022.

MediWound Ltd. (Nasdaq: MDWD) announced positive results from a Phase 2 study of EscharEx, a biotherapeutic solution for debridement in venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The study found that 70% of patients achieved complete debridement within up to 8 applications, with an average of 3.9 applications required. A significant reduction of 35% in wound size and effective biofilm disruption were noted. EscharEx was well-tolerated with ongoing biomarker analysis, underscoring its potential as a non-surgical treatment option.

MediWound Ltd. (Nasdaq: MDWD) will host an in-person Key Opinion Leader (KOL) breakfast meeting on EscharEx on July 12, 2022, at the St. Regis Hotel, New York City. Starting at 8:00 AM ET, the event will feature presentations from leading experts discussing wound debridement practices and EscharEx's clinical study results. CEO Ofer Gonen will provide a company update, followed by a Q&A session. The event will be webcast for those unable to attend in person. EscharEx is aimed at treating chronic wounds, showcasing MediWound's commitment to innovative wound care solutions.

MediWound Ltd. (Nasdaq: MDWD) has appointed Tzvi Palash as Chief Operating Officer (COO), effective June 30, 2022. Palash brings over 35 years of operational experience from prominent pharmaceutical companies. His previous roles include COO at Enlivex and Gamida Cell, where he oversaw critical BLA submissions. His expertise will support MediWound's development of EscharEx and the resubmission of the NexoBrid BLA. NexoBrid is a bromelain-based product for burn care marketed in the EU and at the registration stage in the U.S., backed by BARDA.

MediWound Ltd. (Nasdaq: MDWD) has appointed Ofer Gonen as its new Chief Executive Officer, effective June 30, 2022, succeeding Sharon Malka, who will transition to the Board of Directors. Gonen brings over 20 years of experience in life sciences and business development, previously serving as CEO of Clal Biotechnology Industries, MediWound's largest shareholder. The leadership change aims to position the company for long-term growth and enhance its capabilities in treating burns and wound care.

MediWound Ltd. (NASDAQ: MDWD) announced its Q1 2022 financial results, reporting revenues of $4.4 million, a 24% decline from $5.8 million in Q1 2021. The company faced a 56% drop in product revenue, primarily due to decreased emergency stockpile procurement by BARDA. Despite a net loss of $3.6 million or $0.12 per share, MediWound highlighted the positive results from its U.S. Phase 2 trial of EscharEx®, achieving primary and secondary endpoints with no safety issues. The company has raised $10 million through equity offerings and is on track for NexoBrid BLA resubmission by mid-year.