MediWound Ltd. - MDWD STOCK NEWS

MediWound Ltd. (Nasdaq: MDWD) has updated its EscharEx clinical development program, reducing the Phase 2 adaptive design study sample size to 120 patients due to COVID-19 related delays. This adjustment follows positive results from prior studies. The interim assessment is expected mid-2021 with complete enrollment by year-end 2021. Additionally, a protocol for a pharmacological study has been submitted to the FDA, with data anticipated in the second half of 2021. The company is optimistic about EscharEx's potential in chronic wound management.

MediWound Ltd. (Nasdaq: MDWD) announced its participation in the upcoming LifeSci Partners 10th Annual Corporate Access Event and the H.C. Wainwright BioConnect 2021 Conference, both held virtually. The LifeSci event will occur from January 6-8 and January 11-14, offering virtual 1x1 meetings with institutional investors. The BioConnect conference will take place from January 11-14, with a corporate update session available on-demand starting January 11 at 6:00 am (EST). MediWound focuses on innovative therapies for severe burns and chronic wounds, with products like NexoBrid and EscharEx.

MediWound Ltd. (Nasdaq: MDWD) announced the successful completion of a pre-clinical study evaluating EscharEx, an innovative enzymatic debridement agent, against a commercially available collagenase agent. The study, conducted using a porcine model, showed that EscharEx outperformed the collagenase agent in removing eschars. Results will be published in a peer-reviewed journal in the first half of 2021. The company continues to advance its U.S. Phase 2 study for EscharEx, which has shown promising safety and efficacy in treating chronic wounds.

MediWound Ltd. (Nasdaq: MDWD) has expanded its global presence by entering the UAE market through a distribution agreement with Ghassan Aboud Group (GAG). GAG will exclusively market NexoBrid for severe burn treatment, pending regulatory approval expected within a year. This partnership is influenced by the recent Abraham Accords. NexoBrid is a biological product that safely removes nonviable burn tissue and is already approved in Europe and other regions. The FDA is reviewing its Biologics License Application, with a target decision date of June 29, 2021.

MediWound Ltd. (Nasdaq: MDWD) reported third-quarter 2020 revenues of $6.6 million, a 29% increase year-over-year, primarily due to NexoBrid® procurement by BARDA. Gross profit rose to $2.8 million, achieving a 42% gross margin. The FDA accepted the BLA for NexoBrid with a PDUFA goal date set for June 29, 2021. However, net losses for the nine-month period were $7.5 million, up from a profit of $8.4 million in 2019, impacted by the absence of a significant upfront license payment. MediWound's cash reserves stood at $25 million as of September 30, 2020, reflecting efficient operational management.

MediWound Ltd. (Nasdaq: MDWD) announced the upcoming release of its third-quarter financial results for the period ending September 30, 2020, scheduled for November 10, 2020, at 7:00 am ET. Following the announcement, a conference call will be held at 8:30 am ET to discuss the results. MediWound specializes in innovative therapies for severe burn and wound management, with notable products like NexoBrid and EscharEx, both leveraging patented proteolytic enzyme technology. NexoBrid has received marketing authorization in several countries, underscoring the company's regulatory progress.

MediWound Ltd. has completed enrollment for its Phase 3 pediatric clinical study of NexoBrid, aimed at treating severe burns in children. Following FDA's approval for expanded access to pediatric patients, the study involves 145 participants and will compare NexoBrid against standard care over a 12 and 24-month follow-up. Top-line results are expected in the second half of 2021. Funded by BARDA, the trial addresses significant challenges faced in pediatric burn management, potentially expanding NexoBrid's applications.

MediWound Ltd. (Nasdaq: MDWD) is investigating the effects of EscharEx on biofilm burden in chronic wounds, focusing on its potential to improve wound healing. Biofilms are linked to delayed healing and infections in 60%-100% of chronic wounds. Conventional treatment can be painful and costly, leading to interest in enzymatic debridement as a less invasive alternative. Preclinical studies suggest enzymes, including bromelain, could effectively disrupt biofilms. MediWound intends to conduct pharmacological studies to evaluate EscharEx's potential benefits on biofilms in chronic wounds.

MediWound Ltd. (NASDAQ: MDWD) announced that the FDA accepted its Biologics License Application (BLA) for NexoBrid® for eschar removal in patients with deep partial and full-thickness thermal burns. The FDA has set a PDUFA date of June 29, 2021, with no advisory committee meeting planned. The submission includes data from the pivotal Phase 3 DETECT trial that met its primary and secondary endpoints. NexoBrid is already approved in the EU and designated as an orphan biologic drug in multiple regions. Vericel Corporation holds exclusive North American rights, and BARDA supports the development.