SEC Form SC 13G filed by Aldeyra Therapeutics Inc.
$ALDX
Biotechnology: Pharmaceutical Preparations
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/3/2024 | $10.00 | Perform → Outperform | Oppenheimer |
| 4/2/2024 | $10.00 | Buy | H.C. Wainwright |
| 4/27/2022 | $15.00 | Buy | H.C. Wainwright |
| 12/21/2021 | $25.00 → $21.00 | Buy | Citigroup |
| 12/21/2021 | $24.00 → $15.00 | Outperform | SVB Leerink |
Oppenheimer upgraded Aldeyra Therapeutics from Perform to Outperform and set a new price target of $10.00
H.C. Wainwright resumed coverage of Aldeyra Therapeutics with a rating of Buy and set a new price target of $10.00
H.C. Wainwright resumed coverage of Aldeyra Therapeutics with a rating of Buy and set a new price target of $15.00
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection) for the treatment of inherited retinal dystrophies of the rod-dominant phenotype, including retinitis pigmentosa. There are currently no approved drug treatments for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. Retinitis pigmentosa affects more than one million people worldwide and remains a significant cause of inherited blindness. "Retinitis pigmentosa is a serious and incurable sight-threatenin
PDUFA Target Action Date December 16, 2025 Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. "Based on the FDA's requirement for an additional clinical trial demonstrating the efficacy of reproxalap in treating the symptoms of dry eye disease, and per agreement with the FDA, the NDA resubmission contained a single
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced receipt of a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) for ADX-2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL), a rare and potentially fatal cancer currently lacking FDA-approved therapy. "Primary vitreoretinal lymphoma is treated today off label with intravitreal injections of compounded methotrexate," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "ADX-2191, a novel, vitreous-compatible formulation of methotrexate that is specifically designed for intr
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
4 - Aldeyra Therapeutics, Inc. (0001341235) (Issuer)
8-K - Aldeyra Therapeutics, Inc. (0001341235) (Filer)
8-K - Aldeyra Therapeutics, Inc. (0001341235) (Filer)
8-K - Aldeyra Therapeutics, Inc. (0001341235) (Filer)
In a Dry Eye Chamber Trial, Reproxalap Was Statistically Superior (P=0.002) to Vehicle in Primary Endpoint of Ocular Discomfort Aldeyra Believes the Dry Eye Chamber Trial Results, including No Notable Differences in Baseline Scores Across Treatment Arms, Potentially Address FDA Feedback following the Prior NDA Review New Drug Application Resubmission Is Anticipated Mid‑2025 A Recently Completed Dry Eye Disease Field Trial, which Was Numerically Supportive of Reproxalap and Consistent with Prior Field Trials, Did Not Reach Statistical Significance, and Is Expected to be Submitted to the Planned NDA Resubmission as Supportive Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechno
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, May 6, 2025, at 8:00 a.m. ET to announce topline results from Phase 3 dry eye disease clinical trials of reproxalap. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 127477. A live audio webcast of the conference call will also be accessible from the "Investors & Media" section of Aldeyra's website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra's website for 90 days. About Reproxalap Reproxalap is an investigational new drug candidate in development for the
Top-Line Data from Dry Eye Chamber Trial and Field Trial Expected in Q2 2025 Pending Positive Results and Discussions with the FDA, New Drug Application Resubmission Expected Mid-Year 2025 Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. Although no manufacturing or safety issues with reproxalap were id
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the appointment of Chip Clark to the company's board of directors. "Chip possesses a wealth of experience leading innovative biotechnology companies," stated Richard H. Douglas, Ph.D., Chairman of the Board at Aldeyra Therapeutics. "We look forward to leveraging his expertise as Aldeyra continues to advance a pipeline focused on addressing significant unmet medical needs in immune-mediated and metabolic diseases." Mr. Clark has more than three decades of leadership experience in the
SC 13G/A - Aldeyra Therapeutics, Inc. (0001341235) (Subject)
SC 13G/A - Aldeyra Therapeutics, Inc. (0001341235) (Subject)
SC 13G - Aldeyra Therapeutics, Inc. (0001341235) (Subject)