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) has announced the appointment of Chip Clark to its Board of Directors. Clark brings over three decades of biopharmaceutical leadership experience and currently serves as Co-founder and CEO of Vibrant Biomedicines. His extensive background includes roles as CEO of Genocea Biosciences, Chief Business Officer at Vanda Pharmaceuticals, and Principal at Care Capital.
Aldeyra is focused on developing innovative therapies for immune-mediated and metabolic diseases. Their pipeline includes RASP modulators ADX-629, ADX-248, ADX-743, ADX-631, ADX-246, and late-stage candidates reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191 for retinitis pigmentosa treatment.
Aldeyra Therapeutics (ALDX) has received a Complete Response Letter from the FDA regarding its New Drug Application (NDA) for reproxalap, a treatment for dry eye disease. The FDA cited that the NDA failed to demonstrate efficacy in treating ocular symptoms and requested at least one additional controlled study.
The company is currently conducting three clinical trials: two dry eye chamber trials and a six-week field trial. Top-line data from these ongoing trials is expected in Q2 2025, with a potential NDA resubmission planned for mid-year 2025. The review period for the resubmission is expected to be six months.
Aldeyra reported $101 million in cash and equivalents as of December 31, 2024. The full-year 2025 costs for the ongoing dry eye clinical trials are projected at $6 million, with the majority of trial costs already incurred in 2024.
Aldeyra Therapeutics (Nasdaq: ALDX), a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, has announced its participation in the 2025 Leerink Partners Global Healthcare Conference in Miami, Florida.
The company's President and CEO, Todd C. Brady, M.D., Ph.D., will engage in a fireside chat with Marc Goodman, Senior Managing Director, Neuroscience. The discussion is scheduled for Monday, March 10, 2025, at 9:20 a.m. ET.
Interested parties can access the live webcast through the Investors & Media section of Aldeyra's website. The webcast recording will remain available for 90 days following the event.
Aldeyra Therapeutics (ALDX), a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, has announced its participation in Oppenheimer's 35th Annual Healthcare Life Sciences Conference. The virtual event will feature a fireside chat with Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, and Francois Brisebois, Managing Director and Senior Biotech Research Analyst.
The discussion is scheduled for February 11, 2025, at 9:20 a.m. ET. Investors can access the live webcast through the Investors & Media section of Aldeyra's website. The recorded session will remain available for 90 days following the event.
Aldeyra Therapeutics (ALDX), a biotech company focused on immune-mediated and metabolic diseases, announced its participation in the Citi 2024 Global Healthcare Conference. CEO Todd C. Brady will join the Eyes Wide Open on Ophthalmology Panel on December 5, 2024, at 1:45 p.m. ET in Miami, Florida. The conference runs from December 2-5, 2024. A live webcast will be available on Aldeyra's investor relations website and archived for 90 days afterward.
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.
