Aldeyra Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure
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Date of Report (Date of earliest event reported): May 6, 2025 (
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Item 7.01. Regulation FD Disclosure.
On May 5, 2025, Aldeyra Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) to announce the achievement of the primary endpoint of ocular discomfort in the Phase 3 dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for the treatment of dry eye disease, and the plan to resubmit a New Drug Application. The Company is holding a conference call regarding the announcement on May 6, 2025. A copy of the supplemental presentation which will be referenced during the conference call and posted on the Company’s website 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 May 5, 2025, the Company issued the Press Release to announce the achievement of the primary endpoint of ocular discomfort in the Phase 3 dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for the treatment of dry eye disease, and the plan to resubmit a New Drug Application. The Press Release is filed herewith as Exhibit 99.2 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Aldeyra Therapeutics, Inc. Presentation dated May 6, 2025 | |
| 99.2 | Aldeyra Therapeutics, Inc. Press Release dated May 5, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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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.
| ALDEYRA THERAPEUTICS, INC. | ||
| By: | /s/ Todd C. Brady | |
| Name: | Todd C. Brady, M.D., Ph.D. | |
| Title: | Chief Executive Officer | |
Dated May 6, 2025
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