Welcome to our dedicated page for Aldeyra Therapeu 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.
The Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) SEC filings page provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. As a clinical-stage biotechnology issuer focused on immune-mediated and metabolic diseases, Aldeyra uses current reports on Form 8-K and periodic reports on Forms 10-K and 10-Q to describe its product candidates, development risks, and key milestones.
In its recent Form 8-K filings, Aldeyra has reported material events such as the extension of the Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application of topical ocular reproxalap for dry eye disease, the receipt of a Special Protocol Assessment agreement letter from the U.S. Food and Drug Administration for ADX-2191 in primary vitreoretinal lymphoma, and Fast Track Designation for ADX-2191 in retinitis pigmentosa. Other 8-Ks reference press releases on Phase 2 clinical results for ADX-629 in alcohol-associated hepatitis, expansion of the RASP platform into central nervous system diseases, and updates to the company’s pipeline and projected operational cash runway.
Aldeyra’s annual and quarterly reports, referenced in its 8-Ks, include sections such as “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These documents discuss uncertainties related to clinical trial timing, regulatory approvals, potential labeling outcomes, commercialization prospects, competition, reimbursement, and the company’s status as an early-stage developer that may not generate significant revenue.
On this page, AI-powered tools can help summarize lengthy ALDX filings, highlight mentions of key programs like reproxalap and ADX-2191, and surface information on development timelines, regulatory designations, and other disclosures that matter to investors. Users can also review real-time updates as new Aldeyra filings are posted to the SEC’s EDGAR system, including future 10-K, 10-Q, and 8-K reports, as well as any Forms 3, 4, or 5 that may relate to insider transactions.
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
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
Liquidity and balance sheet: Cash and cash equivalents were
Strategic items: Deferred collaboration revenue remained
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 officer and director Michael Alfieri reported a non-derivative purchase of 2,500 shares of Aldeyra common stock on 08/13/2025 at a reported price of $5.30 per share. Following the transaction he beneficially owns 2,500 shares directly. The Form 4 was signed on 08/15/2025.
Perceptive Advisors and affiliated parties report a 6.8% stake in Aldeyra Therapeutics (ALDX), representing 4,051,631 shares. The filing states the Master Fund directly holds the shares, with Perceptive Advisors as investment manager and Joseph Edelman as managing member, each deemed to beneficially own the shares. All reported shares reflect shared voting and dispositive power (no sole power). The ownership percentage is calculated using 59,895,588 outstanding shares of common stock as reported by the issuer. The filers certify the holdings were not acquired to influence control.
Stephen Machatha, Chief Development Officer of Aldeyra Therapeutics (ALDX), reported the sale of 22,073 shares of common stock on 08/11/2025. The disposals were executed to cover tax withholding obligations upon settlement of time-based restricted stock units. The sales produced a weighted average price of $5.1517, with individual trade prices in the range of $5.06 to $5.29. After the reported transactions the reporting person beneficially owned 221,799 shares, which includes 7,101 shares acquired under the company’s Employee Stock Purchase Plan. No derivative securities were reported.