UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01. Other Events
On July 17, 2024, Longeveron Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for the Company’s lead investigational product Lomecel-BTM, an allogeneic medicinal signaling cell therapy product isolated from the bone marrow of young, healthy adult donors, for the treatment of mild Alzheimer’s disease. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
Fast Track designation is available to a product if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition (or serious aspect of a condition), and it demonstrates the potential to address unmet medical needs for such a disease or condition (i.e., there is no available therapy for the condition, or the condition’s treatment or diagnosis is not adequately addressed by currently available therapies). This designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product may reach the market expeditiously. Investigational therapies that receive Fast Track designation may be eligible for Priority Review (i.e., review of an application within six (6) months of receipt versus 10 months) if relevant criteria are met at the time of application submission to the FDA, as well as rolling FDA review (i.e., the FDA may consider reviewing portions of an application before the complete application is submitted).
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The exhibits listed in the following Exhibit Index are filed as part of this Current Report on Form 8-K.
| Exhibit No. | Description | |
| 99.1 | Press Release issued by the Company on July 17, 2024 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |
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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 hereunto duly authorized.
| LONGEVERON INC. | ||
| Date: July 17, 2024 | /s/ Wa’el Hashad | |
| Name: | Wa’el Hashad | |
| Title: | Chief Executive Officer | |
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