Aldeyra Therapeutics Files 8-K: Material Agreement

TL;DR

Aldeyra signed a big deal, filing an 8-K on Nov 18th.

AI Summary

Aldeyra Therapeutics, Inc. announced on November 15, 2024, that it entered into a material definitive agreement. The company also reported other events and filed financial statements and exhibits as part of this 8-K filing on November 18, 2024.

Why It Matters

This filing indicates Aldeyra Therapeutics has entered into a significant agreement, which could impact its business operations, strategic direction, and financial performance.

Risk Assessment

Risk Level: medium — Material definitive agreements can introduce new risks or opportunities, requiring further analysis of the agreement's terms and implications.

Key Players & Entities

• Aldeyra Therapeutics, Inc. (company) — Registrant
• November 15, 2024 (date) — Earliest event reported
• November 18, 2024 (date) — Date of report

FAQ

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share ALDX The Nasdaq

Filing Documents

• ea0221568-8k_aldeyra.htm (8-K) — 35KB
• ea022156801ex99-1_aldeyra.htm (EX-99.1) — 14KB
• ex99-1_001.jpg (GRAPHIC) — 4KB
• 0001213900-24-099333.txt ( ) — 233KB
• aldx-20241115.xsd (EX-101.SCH) — 3KB
• aldx-20241115_lab.xml (EX-101.LAB) — 33KB
• aldx-20241115_pre.xml (EX-101.PRE) — 22KB
• ea0221568-8k_aldeyra_htm.xml (XML) — 4KB

01. Other Events

Item 8.01. Other Events. On November 18, 2024, the Company issued a press release (the "Press Release") to announce the Extension Letter and that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease, and has assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025. The Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. Various statements contained in this Current Report on Form 8-K are "forward-looking statements" under the securities laws, including, but not limited to, statements regarding relating to the likelihood and timing of the FDA's potential approval of the resubmitted NDA for reproxalap by the PDUFA date of April 2, 2025, or at any other time, the adequacy of the data included in the previously submitted NDA and the resubmitted NDA, the potential profile, benefit and market size of reproxalap in dry eye disease should the resubmitted NDA for reproxalap be approved by the FDA. In some cases, you can identify forward looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. 1 Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, Aldeyra's plans to develop and commercialize product candidates, if they are approved; d

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Aldeyra Therapeutics, Inc. Press Release dated November 18, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 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 hereunto duly authorized. Dated November 18, 2024 ALDEYRA THERAPEUTICS, INC. By: /s/ Todd C. Brady Name: Todd C. Brady M.D., Ph.D. Title: Chief Executive Officer 3

View Full Filing

View this 8-K filing on SEC EDGAR