Aldeyra Therapeutics develops investigational therapies for immune-mediated diseases, with news centered on its RASP modulator platform and late-stage ocular programs. Company updates commonly cover reproxalap, a RASP modulator for dry eye disease and allergic conjunctivitis; ADX-2191, an intravitreal methotrexate formulation for primary vitreoretinal lymphoma and retinitis pigmentosa; and next-generation RASP modulators including ADX-248 and ADX-246 for systemic and retinal immune-mediated diseases.
Recurring developments include FDA interactions on the reproxalap New Drug Application, clinical and preclinical results, pipeline prioritization, manufacturing and regulatory disclosures, and research-and-development presentations. Aldeyra also reports conference participation and corporate updates tied to its Nasdaq-listed biotechnology issuer profile.
Aldeyra Therapeutics (ALDX) plans to ask the FDA to reconsider its rejection of reproxalap for dry eye disease. The planned Formal Dispute Resolution Request would appeal a March 16, 2026 Complete Response Letter, the third issued after Aldeyra’s initial application and two resubmissions. The first two letters recommended another clinical trial. The latest did not request one but stated that the evidence from completed trials did not support the product’s effectiveness.
Aldeyra provided data from nine adequate and well-controlled trials, five of which met all multiplicity-controlled primary endpoints. It expects to submit the request and meet with the FDA’s Office of New Drugs in the fourth quarter of 2026; the decision date remains uncertain. Aldeyra also updated its guidance to project operational cash runway into 2029, based on $45.1 million in cash and cash equivalents as of June 30, 2026.
Aldeyra Therapeutics (ALDX) will host a regulatory update webcast on investigational dry eye drug reproxalap on September 29, 2026. The event begins at 8:00 a.m. ET. A live audio webcast and slide presentation will be available through the company’s Investors & Media website section for 90 days following the event.
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Aldeyra Therapeutics (Nasdaq: ALDX) announced that President and CEO Todd C. Brady, M.D., Ph.D., will join a fireside chat at the 2026 Jefferies Global Healthcare Conference in New York.
The discussion with Jefferies biotechnology equity research will be webcast live at 8:45 a.m. ET on Thursday, June 4, 2026, via Aldeyra’s Investors & Media website and archived for 90 days.
Aldeyra Therapeutics (Nasdaq: ALDX) received a Complete Response Letter from the FDA for the reproxalap NDA for treatment of dry eye disease, citing a failure to demonstrate efficacy and inconsistent study results.
No safety or manufacturing issues were identified, and the company reports $70 million cash supporting operations into 2028 while it requests a Type A meeting.
Aldeyra Therapeutics (Nasdaq: ALDX) announced that President and CEO Todd C. Brady, M.D., Ph.D. will participate virtually in a fireside chat at the Oppenheimer 36th Annual Healthcare Life Sciences Conference.
The conversation with Andreas Argyrides is scheduled for 10:40 a.m. ET on Wednesday, February 25, 2026. According to the company, the live webcast will be available via the Investors & Media section of Aldeyra's website and archived for 90 days.
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.