Aldeyra Therapeutics, Inc. - ALDX STOCK NEWS

Aldeyra Therapeutics (ALDX) announced FDA acceptance of its resubmitted New Drug Application (NDA) for reproxalap, a first-in-class drug candidate for dry eye disease treatment, with a PDUFA date set for April 2, 2025. The company also expanded its option agreement with AbbVie, which could receive a co-exclusive license for reproxalap in the US. Upon option exercise, AbbVie would pay $100M upfront (less $6M in previous fees), with potential additional regulatory and commercial milestone payments up to $300M, including $100M upon FDA approval. The profit-sharing agreement in the US would be 60% AbbVie and 40% Aldeyra.

Aldeyra Therapeutics (ALDX), a biotech company focused on immune-mediated and metabolic diseases, has announced its participation in the Jefferies London Healthcare Conference 2024. President and CEO Todd C. Brady will engage in a fireside chat with Jefferies' Senior VP of Biotechnology Equity Research, Kelly Shi, on November 21, 2024, at 12:30 p.m. GMT. The conference runs from November 19-21, 2024, in London. A live webcast will be available on Aldeyra's investor relations website and archived for 90 days afterward.

Aldeyra Therapeutics (ALDX) has announced its participation in the Disruptive Innovations Symposium at the OSN New York Retina 2024 Meeting, scheduled for November 8-10, 2024. Dr. Tomasz Stryjewski, Chief Medical Advisor - Retina, will present on the Phase 2/3 clinical development of ADX-2191 for retinitis pigmentosa treatment on November 8, 2024, from 3:30-5:30 p.m. ET.

The company specializes in developing therapies for immune-mediated and metabolic diseases, focusing on RASP modulators including ADX-629, ADX-248, ADX-743, and ADX-631. Their late-stage candidates include reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191, an intravitreal methotrexate formulation for retinitis pigmentosa.

Aldeyra Therapeutics (Nasdaq: ALDX) has resubmitted a New Drug Application (NDA) to the FDA for topical ocular reproxalap, a potential treatment for dry eye disease. The resubmission includes positive results from a recent dry eye disease symptom trial and a draft label reflecting:

• Acute activity in reducing dry eye symptoms in a chamber trial
• Chronic activity in reducing symptoms in a field trial
• Acute activity in reducing ocular redness in two chamber trials

In August 2024, Aldeyra announced achieving the primary endpoint in a Phase 3 trial, demonstrating reproxalap's statistical superiority over vehicle for ocular discomfort (P=0.004). The company believes this supports reproxalap's potential for rapid clinical effect in reducing dry eye discomfort.

Aldeyra Therapeutics (Nasdaq: ALDX), a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will engage in a fireside chat with Matthew Caufield, Director of Equity Research at H.C. Wainwright & Co.

The conversation is scheduled for September 11, 2024, at 11:30 a.m. ET. Investors and interested parties can access the live webcast through the Investors & Media section of Aldeyra's website. The webcast will remain archived for 90 days following the event, providing an opportunity for those unable to attend live to catch up on the discussion.

Aldeyra Therapeutics (ALDX) has achieved the primary endpoint in a Phase 3 clinical trial of reproxalap for dry eye disease. The trial demonstrated statistically superior results for reproxalap over vehicle in reducing ocular discomfort, an FDA-accepted symptom of dry eye disease. This marks the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint.

The study involved 132 patients, with 66 receiving reproxalap and 66 receiving vehicle. Reproxalap was well-tolerated with no safety concerns. Aldeyra plans to resubmit its New Drug Application (NDA) in 2024, with an expected six-month FDA review period. The company believes these results support reproxalap's potential for rapid clinical effect in reducing ocular discomfort associated with dry eye disease.

Aldeyra Therapeutics (Nasdaq: ALDX) has announced a webcast and conference call scheduled for August 8, 2024, at 9:00 a.m. ET to reveal top-line results from the Phase 3 dry eye disease clinical trial of reproxalap. The company, focused on developing therapies for immune-mediated and metabolic diseases, will provide dial-in numbers for domestic and international callers, with a live audio webcast accessible from their website. Aldeyra's pipeline includes RASP modulators for various systemic and retinal diseases, with reproxalap targeting dry eye disease and allergic conjunctivitis, and ADX-2191 for potential treatment of retinitis pigmentosa.

Aldeyra Therapeutics announced significant advancements in its RASP modulator pipeline and recent preclinical obesity data at its 2024 Investor Roundtable. Key updates include ADX-629 moving to pediatric Phase 2 trials for Sjögren-Larsson Syndrome, with top-line results expected in 2025. ADX-743, showing promising results in lowering triglycerides and fatty acids, is advancing to IND-enabling studies, with an application expected in 2025. ADX-248 will start Phase 1 clinical testing for atopic dermatitis in the second half of 2024. ADX-631 begins preclinical testing for retinal diseases, with an IND application planned for 2025. CEO Todd C. Brady emphasized the expansion of their RASP modulator pipeline for treating inflammatory and metabolic diseases. The Investor Roundtable, including a live webcast, is scheduled for today at 8:00 a.m. ET, with a replay available for 90 days.

Aldeyra Therapeutics (Nasdaq: ALDX) has completed enrollment for its Phase 3 clinical trial of Reproxalap, a topical ocular treatment for dry eye disease. The trial, which enrolled 132 patients, aims to assess ocular discomfort and potentially enable a New Drug Application (NDA) resubmission in the second half of 2024. Previous trials showed statistically significant improvements in ocular discomfort when treated with Reproxalap versus a vehicle. Results are expected in Q3 2024. If successful, this could lead to the first dry eye disease label incorporating clinical data on both chronic symptoms and ocular redness.