Welcome to our dedicated page for Aldeyra Therapeutics SEC filings (Ticker: ALDX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Aldeyra Therapeutics SEC filings document a biotechnology issuer focused on investigational therapies for immune-mediated diseases and formal disclosures tied to its RASP modulator pipeline. Recent 8-K reports furnish press releases and corporate presentations covering reproxalap regulatory review, clinical and preclinical program updates, pipeline prioritization, and FDA-related disclosures for dry eye disease.
The filing record also covers governance and capital-structure matters, including definitive proxy materials for annual meeting proposals and director elections, board-transition disclosures, and the payoff and termination of the Hercules Credit Facility. These filings group Aldeyra's public-company record around operating updates, risk and forward-looking-statement disclosures, stockholder voting matters, and financing arrangements.
Aldeyra Therapeutics Inc ownership disclosure: The Vanguard Group amended its Schedule 13G to report 0 shares beneficially owned, representing 0% of the Common Stock as disclosed in the amendment.
The filing states Vanguard completed an internal realignment on January 12, 2026 and, "in accordance with SEC Release No. 34-39538 (January 12, 1998)", certain subsidiaries will report ownership separately.
Aldeyra Therapeutics director Richard Douglas bought more company stock in the open market. He acquired 70,000 shares of common stock in an open-market purchase at $1.40 per share. Following this transaction, he directly owns 195,000 shares, indicating a larger personal stake in Aldeyra Therapeutics.
Aldeyra Therapeutics, Inc. Principal Financial Officer Michael Alfieri reported an open-market purchase of common stock. On this transaction date, he bought 5,000 shares at a price of $1.42 per share. Following the purchase, his direct ownership increased to 7,500 common shares.
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 outlines its strategy as a late‑stage biotechnology company developing RASP modulators and the intravitreal methotrexate product ADX‑2191 for immune‑mediated eye and systemic diseases. Lead candidate reproxalap targets dry eye disease and allergic conjunctivitis, but has received multiple FDA Complete Response Letters requiring additional symptom‑focused trials.
The company has granted AbbVie an exclusive option to co‑develop and commercialize reproxalap, which, if exercised, would include a $100.0 million upfront payment (offset by prior option fees) and up to about $300.0 million in milestones, plus a 60/40 U.S. profit‑share and ex‑U.S. royalties. ADX‑2191 holds orphan and fast track designations in certain indications, with an FDA‑agreed SPA for primary vitreoretinal lymphoma and expansion plans in retinitis pigmentosa.
Perceptive Advisors and affiliates report a 7.0% stake in Aldeyra Therapeutics, Inc. They beneficially own 4,185,632 shares of common stock, based on 60,162,773 shares outstanding as of November 4, 2025. The Perceptive Life Sciences Master Fund directly holds the shares, with Perceptive Advisors as investment manager and Joseph Edelman as managing member.
The reporting persons state that the securities were not acquired and are not held for the purpose of changing or influencing control of Aldeyra, consistent with a passive investment under Schedule 13G.
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 reported Q3 2025 results with a net loss of $7,688,341, reflecting lower operating expenses year over year. Research and development expense was $5,430,757 (down from $12,441,509), and general and administrative expense was $2,570,375 (down from $3,696,067). Total other income, net, was $312,791, driven by interest income of $788,694 and interest expense of $475,903.
Liquidity and balance sheet: Cash and cash equivalents were $59,340,599 and marketable securities were $15,956,740 as of September 30, 2025. Total assets were $77,801,012 and stockholders’ equity was $49,244,543. Current portion of debt was $15,199,265, with the Hercules facility maturing on April 1, 2026 and interest‑only payments through that date under the amendment. The company stated its cash, cash equivalents, and marketable securities are expected to fund operations for at least the next 12 months.
Strategic items: Deferred collaboration revenue remained $6,000,000 related to the AbbVie option; as of November 5, 2025, AbbVie had not exercised the option. Under its $75.0 million at‑the‑market program, no shares were sold as of quarter end.
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.