Welcome to our dedicated page for Aldeyra Therapeu news (Ticker: ALDX), a resource for investors and traders seeking the latest updates and insights on Aldeyra Therapeu stock.
Aldeyra Therapeutics (ALDX) is a clinical-stage biotechnology company developing innovative therapies targeting diseases mediated by toxic aldehydes, with active programs in ocular inflammation and systemic immune disorders. This page provides investors and industry professionals with comprehensive access to Aldeyra's official announcements, including clinical trial updates, regulatory milestones, and strategic partnerships.
Key resources include real-time updates on product candidates like reproxalap for dry eye disease, filings with regulatory agencies, and research collaborations. Users gain a centralized hub to track the company's progress in addressing conditions such as noninfectious anterior uveitis and metabolic disorders through its novel aldehyde sequestration platform.
Regular updates cover Phase clinical results, FDA communications, intellectual property developments, and scientific presentations. The curated news feed enables efficient monitoring of Aldeyra's pipeline advancements and market positioning within the precision medicine landscape.
Bookmark this page for direct access to verified ALDX disclosures and analysis essential for evaluating the company's therapeutic innovations and investment potential.
Aldeyra Therapeutics (Nasdaq: ALDX) announced the FDA extended the PDUFA target action date for the reproxalap NDA for dry eye disease to March 16, 2026. The NDA was submitted on June 16, 2025 and accepted as a complete class 2 response on July 16, 2025 with an original PDUFA date of December 16, 2025.
On December 12, 2025 the FDA requested the Clinical Study Report (CSR) for a field trial that did not meet its primary symptom endpoint; the CSR was submitted the same day and considered a major amendment. The FDA previously received safety data on August 21, 2025 and shared a draft prospective label, to which Aldeyra responded. The FDA said it plans to communicate proposed labeling requests and possible postmarketing requirements by February 16, 2026 if no major deficiencies are found.
Aldeyra will host a conference call and webcast on December 16, 2025 at 8:00 a.m. ET to discuss the PDUFA extension.
Aldeyra Therapeutics (Nasdaq: ALDX) announced expansion of its RASP platform to include central nervous system (CNS) diseases and provided reproxalap manufacturing updates on Nov 13, 2025.
New preclinical results for orally administered ADX-248 showed improved grip strength, balance, and CNS biomarkers in Parkinson’s disease and ALS models, prompting expanded potential indications to neuroinflammatory CNS diseases. FDA completed 2025 inspections of reproxalap drug substance and product sites, assigned Voluntary Action Indicated (VAI) designations, and notified manufacturers the inspections are closed with no further action required.
Aldeyra Therapeutics (Nasdaq: ALDX) announced that President and CEO Todd C. Brady, M.D., Ph.D. will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference in London.
The session with Clara Dong, Ph.D., Vice President, Biotechnology Equity Research at Jefferies, is scheduled for 11:30 a.m. GMT on Thursday, November 20, 2025. A live webcast will be available via the company Investors & Media website, and the archived webcast will remain accessible for 90 days.
Aldeyra Therapeutics (Nasdaq: ALDX) said it will host a Research & Development Update webcast on Thursday, November 13, 2025 at 8:00 a.m. ET. The webcast will include a review of the company's pipeline programs and presentations from members of Aldeyra's senior leadership team.
A live audio webcast and slide presentation will be available from the Investors & Media section of Aldeyra's website at https://ir.aldeyra.com/ and will remain accessible for 90 days following the event.
Aldeyra Therapeutics (Nasdaq: ALDX) reported Phase 2 proof-of-concept results for orally administered RASP modulator ADX-629 in four patients with mild-to-moderate alcohol-associated hepatitis showing statistically significant improvement versus baseline in liver function and inflammation: MELD score (P=0.001), triglycerides (P<0.0001), and C-reactive protein (P<0.0001). No serious adverse events were reported and no events were deemed related to ADX-629. Aldeyra is discontinuing clinical development of ADX-629 while advancing next-generation RASP candidates ADX-248 and ADX-246, with anticipated IND filings in 2026. Cash runway is extended into the second half of 2027.
Aldeyra Therapeutics (NASDAQ:ALDX), a biotechnology company focused on immune-mediated and metabolic diseases, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The company's President and CEO, Todd C. Brady, M.D., Ph.D., will engage in a fireside chat with Matthew Caufield, Director of Equity Research at H.C. Wainwright & Co.
The presentation is scheduled for September 8, 2025, at 11:30 a.m. ET. Investors can access the live webcast through Aldeyra's investor relations website, and the recording will be available for 90 days following the event.
Aldeyra Therapeutics (Nasdaq: ALDX) has received Orphan Designation from the European Medicines Agency (EMA) for ADX-2191, a novel intravitreal methotrexate injection designed to treat primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma.
The rare cancer affects 100-200 people annually in the European Union and currently has no approved treatment. A planned clinical trial, approved via Special Protocol Assessment, will evaluate cancer cell clearance in up to 20 patients, comparing single versus eight intraocular injections of ADX-2191. The trial is set to begin in H2 2025 and conclude in 2026.
The EMA's Orphan Designation provides benefits including reduced fees, protocol assistance, and up to 10 years of market exclusivity in the EU.
Aldeyra Therapeutics (NASDAQ:ALDX) has received FDA Fast Track designation for ADX-2191, its intravitreal methotrexate injection treatment for retinitis pigmentosa. This rare genetic eye disease, affecting over 1 million people worldwide, currently has no approved treatments for most forms.
The designation follows positive Phase 2 clinical trial results announced in 2023, which showed improvements in retinal sensitivity. Aldeyra plans to initiate a Phase 2/3 clinical trial in 2025. The Fast Track status, combined with previous Orphan Drug Designation, enables frequent FDA interactions and potential expedited review processes.
Aldeyra Therapeutics (NASDAQ:ALDX), a biotechnology company focused on immune-mediated and metabolic diseases, has announced its participation in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference. The company's President and CEO, Todd C. Brady, M.D., Ph.D., will engage in a fireside chat with Matthew Caufield, Director of Equity Research at H.C. Wainwright & Co., on August 13, 2025, at 10:30 a.m. ET. The discussion will be accessible via webcast through Aldeyra's investor relations website and will remain available for 90 days after the event.
Aldeyra Therapeutics (NASDAQ:ALDX) announced that its ADX-2191 (methotrexate intravitreal injection) has received Orphan Designation from the European Medicines Agency (EMA) for treating inherited retinal dystrophies, including retinitis pigmentosa. This designation follows a previous Orphan Drug Designation from the FDA.
The treatment targets retinitis pigmentosa, a rare genetic eye disease affecting over 1 million people worldwide with no currently approved drug treatments. A Phase 2 clinical trial in 2023 showed improvements in retinal sensitivity. The company plans to initiate a Phase 2/3 clinical trial in 2025.
The EMA's Orphan Designation provides benefits including reduced regulatory fees, clinical protocol assistance, research grants, and up to 10 years of market exclusivity in the EU.
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