Every 8-K that Aldeyra Therapeutics Inc (ALDX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ALDX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ALDX filings page.
Aldeyra Therapeutics, Inc. executed an office lease with Bradford Street, L.L.C. for approximately 4,067 square feet at 23 Bradford Street, Concord, Massachusetts, to serve as its corporate headquarters.
The lease starts on September 1, 2026 and runs through September 30, 2029. It provides for an initial monthly base rent of $12,201.00, which increases annually, plus operating expenses, taxes, and other fees. Aldeyra will post a $50,000.00 security deposit.
Aldeyra Therapeutics, Inc. reports ongoing regulatory interactions with the U.S. Food and Drug Administration related to reproxalap for the treatment of dry eye disease. On July 14, 2026, Aldeyra received minutes from an FDA Type A meeting held on June 10, 2026, which addressed potential resubmission of the New Drug Application for reproxalap.
On July 15, 2026, Aldeyra requested clarification of the FDA’s meeting minutes and intends to request a Type D meeting with the FDA to further discuss potential NDA resubmission. The Type D meeting is expected to be held by the end of the third quarter of 2026.
Aldeyra Therapeutics, Inc. appointed Darlene Deptula-Hicks as a Class III director and Chair of the audit committee following its 2026 annual stockholder meeting. She is considered independent and qualifies as an audit committee financial expert under SEC and Nasdaq rules.
As a new non-employee director, she received a stock option for 94,313 common shares that vests over three years, plus annual cash fees for board and audit chair service and eligibility for additional annual option grants. Stockholders elected Todd C. Brady, M.D., Ph.D., ratified BDO USA, P.C. as auditor for 2026, and approved executive compensation on an advisory basis.
Aldeyra Therapeutics filed an update highlighting FDA feedback on its lead RASP modulator reproxalap, an AbbVie option agreement, and progress across its immunology pipeline. The FDA issued a Complete Response Letter for reproxalap in dry eye disease, citing lack of substantial efficacy evidence and inconsistent trial results, though no safety or manufacturing issues were identified and a Type A meeting is expected in the second quarter of 2026.
The company argues pooled trial data show a clear pattern of reproxalap superiority over vehicle and notes that five of nine efficacy trials met all primary endpoints, with P values below 0.05 for nine of 14 endpoints. Aldeyra also emphasizes strong Phase 3 data in allergic conjunctivitis and multiple early‑stage RASP modulators, rare retinal disease candidate ADX‑2191, and other programs. As of 12/31/2026, cash, cash equivalents, and marketable securities were $70, which Aldeyra believes will be sufficient to fund the company into 2028.
Aldeyra Therapeutics, Inc. reported that Board member Martin J. Joyce has decided not to stand for re-election at the company’s 2026 annual meeting of stockholders. He will continue to serve as a director until his term expires at that meeting.
The company stated that Mr. Joyce’s decision was not the result of any disagreement with Aldeyra, indicating an orderly and voluntary board transition rather than a dispute-driven departure.
Aldeyra Therapeutics, Inc. has fully repaid its debt under the Hercules Credit Facility. On April 1, 2026, the company paid off outstanding borrowings of $15 million, and all remaining commitments under the loan agreement were terminated in line with its April 1, 2026 maturity.
The Hercules Credit Facility, originally entered in March 2019, is now fully closed. The company notes that its cash, cash equivalents, and marketable securities as of December 31, 2025 are expected to support operations into 2028, indicating sufficient liquidity after the loan repayment.
Aldeyra Therapeutics received a Complete Response Letter from the U.S. FDA for its reproxalap New Drug Application to treat the signs and symptoms of dry eye disease. The FDA wrote that the application lacks substantial evidence of efficacy, citing inconsistent study results and questioning the reliability of positive findings.
No safety or manufacturing concerns were identified, but the FDA concluded that the totality of clinical evidence does not support effectiveness. Aldeyra plans to request a Type A meeting to understand what is required for potential approval and acknowledges that additional studies or trials could be required, which would increase costs and delay commercialization. As of December 31, 2025, the company held $70 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2028.
Aldeyra Therapeutics, Inc. reported that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) date for topical ocular reproxalap, an investigational drug candidate for the treatment of signs and symptoms of dry eye disease. The update relates to the ongoing review of the new drug application for reproxalap.
The company issued a press release on December 15, 2025 describing the PDUFA extension and plans to discuss the news on a conference call on December 16, 2025. Aldeyra also includes detailed forward-looking statements about the timing and outcome of regulatory action, the potential labeling and commercial opportunity for reproxalap, and numerous clinical, regulatory, commercial, and financing risks that could cause actual results to differ from current expectations.
Aldeyra Therapeutics (ALDX) announced an R&D webcast and materials. On November 13, 2025, the company is presenting a slide deck at its 2025 Research & Development Webcast, furnished as Exhibit 99.1.
In a related press release filed as Exhibit 99.2, Aldeyra highlights two updates: expansion of its RASP platform to include central nervous system diseases, and manufacturing updates on reproxalap, its first-in-class investigational candidate for the signs and symptoms of dry eye disease.
The company notes forward-looking statements regarding development timelines, regulatory outcomes, and commercialization are subject to risks and uncertainties. Information furnished under Item 7.01 is not deemed “filed” or subject to Section 18 of the Exchange Act.
Aldeyra Therapeutics (ALDX) furnished an 8-K noting it issued a press release announcing positive Phase 2 results in alcohol-associated hepatitis, the prioritization of its RASP modulator product candidates, and an updated pipeline.
The company also reported an extension of its projected operational cash runway into the second half of 2027. The press release is included as Exhibit 99.1.
Aldeyra Therapeutics, Inc. reported that the U.S. Food and Drug Administration has granted Fast Track Designation for its product candidate ADX-2191 for the treatment of retinitis pigmentosa, a serious eye disease that can lead to vision loss. This designation is intended to facilitate the development and expedite the review of drugs that address unmet medical needs. The company disclosed this information through a press release dated August 19, 2025, which is attached as an exhibit to the report.
Aldeyra Therapeutics (NASDAQ:ALDX) filed a Form 8-K reporting receipt of a Special Protocol Assessment (SPA) agreement letter from the FDA covering the pivotal trial design for ADX-2191, its investigational treatment for primary vitreoretinal lymphoma (PVRL). The SPA signals FDA concurrence that the study’s endpoints and analysis, if achieved, are sufficient for a future New Drug Application, materially reducing regulatory risk and potentially accelerating review. The related press release is furnished as Exhibit 99.1 under Item 7.01, with the same event noted under Item 8.01. No financial data, guidance, or operational changes were disclosed.