Aldeyra Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On June 26, 2025, Aldeyra Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) to announce the receipt of a Special Protocol Assessment Agreement Letter (the “SPA”) from the U.S. Food and Drug Administration (the “FDA”) for ADX-2191, an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (“PVRL”). The Press Release is furnished herewith as Exhibit 99.1 and is incorporated by reference herein.
This information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01. Other Events.
As reported under Item 7.01 of this Current Report on Form 8-K, on June 26, 2025, the Company announced the receipt of the SPA from the FDA for ADX-2191 for the treatment of PVRL.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Aldeyra Therapeutics, Inc. Press Release dated June 26, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
| ALDEYRA THERAPEUTICS, INC. | |||
| By: | /s/ Todd C. Brady | ||
| Name: | Todd C. Brady M.D., Ph.D. | ||
| Title: | Chief Executive Officer | ||
| Dated June 26, 2025 | |||
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