MediWound: FDA Accepts NexoBrid Pediatric Burn Application

TL;DR

**FDA accepted MediWound's NexoBrid application for pediatric burns, signaling potential market expansion.**

AI Summary

MediWound Ltd. announced on January 9, 2024, that the FDA has accepted for review its supplemental Biologics License Application (BLA) for NexoBrid. This BLA aims to expand NexoBrid's use to include pediatric patients suffering from severe thermal burns, building on its existing approval for adults. This development is significant for investors because it signals potential market expansion for NexoBrid, which could lead to increased revenue and stock value if approved, as it addresses a critical unmet medical need in a vulnerable patient population.

Why It Matters

This filing indicates a potential expansion of MediWound's flagship product, NexoBrid, into the pediatric market, which could significantly increase its addressable market and future revenue streams.

Risk Assessment

Risk Level: low — The acceptance of the BLA for review is a positive step with low immediate risk, though final approval is not guaranteed.

Analyst Insight

Investors should monitor the FDA's review process for NexoBrid's pediatric indication, as approval could significantly boost MediWound's market potential and stock performance.

Key Players & Entities

• MediWound Ltd. (company) — the registrant and pharmaceutical company
• FDA (company) — the regulatory body that accepted the BLA for review
• NexoBrid (product) — MediWound's product for severe thermal burns
• January 9, 2024 (date) — date of the press release and filing

Forward-Looking Statements

• NexoBrid will receive FDA approval for pediatric severe thermal burns. (NexoBrid) — medium confidence, target: 2024-12-31
• MediWound's revenue will increase following potential market expansion for NexoBrid. (MediWound Ltd.) — medium confidence, target: 2025-12-31

FAQ

Filing Documents

• zk2430760.htm (6-K) — 12KB
• exhibit_99-1.htm (EX-99.1) — 16KB
• image00001.jpg (GRAPHIC) — 3KB
• 0001178913-24-000104.txt ( ) — 33KB

From the Filing

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________ FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January 2024 Commission File Number: 001-36349 MediWound Ltd. (Translation of registrant's name into English) 42 Hayarkon Street Yavne, 8122745 Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F Form 40-F Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): __ Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): __ EXPLANATORY NOTE On January 9, 2024, MediWound Ltd. (the "Company") issued a press release entitled "MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns". A copy of this press release is attached to this Form 6-K as Exhibit 99.1. The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management of the Company), is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019, February 25, 2020, May 15, 2021 August 9, 2022 and August 15, 2023 (Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-230487, 333-236635, 333-255784, 333-266697 and 333-273997, respectively) and on Form F-3 filed with the SEC on May 25, 2022 and March 31, 2023 (Registration Nos. 333-265203 and 333-268297, respectively). 2 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. MEDIWOUND LTD. Date: January 9, 2024 By: /s/ Hani Luxenburg Name: Hani Luxenburg Title: Chief Financial Officer 3 EXHIBIT INDEX The following exhibit is filed as part of this Form 6-K: Exhibit Description 99.1 Press release dated January 9, 2024 titled "MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns". 4

View Full Filing

View this 6-K filing on SEC EDGAR