Business
MediWound Reports Third Quarter 2020 Financial Results
Total Third Quarter Revenues of $6.6 Million Increased 29% Year-over-Year Assigned PDUFA Goal Date of June 29, 2021 for NexoBrid BLA YAVNE, Israel, Nov. 10,
About this update from Mediwound Ltd.
[{"type":"text","content":"Total Third Quarter Revenues of $6.6 Million Increased 29% Year-over-Year\n Assigned PDUFA Goal Date of June 29, 2021 for NexoBrid BLA YAVNE, Israel, Nov. 10, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the third quarter ended September 30, 2020. Third Quarter Business and Financial Highlights: Revenues for the third quarter of 2020 were $6.6 million, an increase of 29% compared with the third quarter of 2019, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA) Cash and short term investments of $25.0 million as of September 30, 2020, compared with $29.5 million as of December 31, 2019Announced the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for NexoBrid and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 29, 2021Delivered the first shipment of NexoBrid to BARDA for emergency response preparednessCompleted enrollment stage of the NexoBrid Phase 3 Children Innovation Debridement Study (CIDS). Top-line data anticipated in the second half of 2021Completed U.S Phase 3 (DETECT) including patient long-term safety follow-up; The twenty-four-month safety data of cosmesis and function was comparable across all study arms with no new safety signals observedContinue to address challenges associated with the COVID-19 pandemic, while prioritizing the health and safety of our workforce and maintaining operational efficiency and flexibility “We generated strong revenue growth in the third quarter, driven by the first delivery of NexoBrid emergency stock to BARDA,” said Sharon Malka, Chief Executive Officer of MediWound. “The quarter was highlighted by several important milestones that bring us closer to our goal of providing a new standard of care for eschar removal in patients with severe burns. Our NexoBrid BLA was accepted for review, we successfully completed the long-term safety patient follow-up stage of our U.S Phase 3 DETECT study, which showed comparable results across all arms, we completed the enrollment stage of our NexoBrid pediatric Phase 3 study and we continue to enroll patients under the NEXT protocol. In...