UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events.
On September 16, 2020, Vericel issued a press release announcing the Food and Drug Administration’s (FDA) acceptance for filing of its recently submitted Biologics License Application (BLA) for NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA has assigned a PDUFA (Prescription Drug User Fee Act) date of June 29, 2021 for its review of the BLA. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support to MediWound Ltd. for development of NexoBrid is provided, in part, by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of Vericel Corporation, dated September 16, 2020 | |
| 104 | Cover page interactive data file (embedded within the Inline XBRL document) |
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release of Vericel Corporation, dated September 16, 2020 | |
| 104 | Cover page interactive data file (embedded within the Inline XBRL document) |
SIGNATURES
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 hereunto duly authorized.
| Vericel Corporation | ||
| Date: September 16, 2020 | By: | /s/ Sean C. Flynn |
| Name: Sean C. Flynn | ||
| Title: Vice President, General Counsel and Secretary | ||