Aldeyra Therapeutics, Inc. - ALDX STOCK NEWS

Aldeyra Therapeutics (Nasdaq: ALDX) announced positive top-line results from a 12-month safety trial of reproxalap for dry eye disease. The trial, involving 447 patients, showed no treatment-related serious adverse events and similar ocular safety metrics across both reproxalap and vehicle groups. Post-hoc analysis indicated that reproxalap significantly improved distance visual acuity by approximately 37%, marking a potential breakthrough as the first topical treatment to demonstrate such improvement. With over 2,300 patients tested, reproxalap continues to show a promising safety profile, reinforcing its viability for regulatory review.

Aldeyra Therapeutics (Nasdaq: ALDX) announced the advancement of two new drug candidates, ADX-246 and ADX-248, into clinical testing for treating systemic immune-mediated diseases and geographic atrophy, respectively. These candidates are part of Aldeyra's innovative drug discovery platform targeting RASP modulation. Pending completion of FDA requirements, a Phase 1 trial for ADX-246 and a Phase 1/2 trial for ADX-248 are expected to start in late 2023 or early 2024. With over 100 million people in the U.S. facing diseases linked to systemic inflammation, these developments underscore Aldeyra's leadership in this therapeutic area.

Aldeyra Therapeutics (NASDAQ: ALDX) announced the initiation of Phase 2 clinical trials for ADX-629, targeting minimal change disease and Sjögren-Larsson Syndrome. The minimal change disease trial will now also include idiopathic nephrotic syndrome. Additionally, a new trial for atopic dermatitis has commenced. Aldeyra's recent credit facility amendment extends its cash runway into the second half of 2024, positioning the company to advance its product candidates, including reproxalap and ADX-2191, if approved. Top-line results are expected in 2023, showcasing the company's commitment to developing innovative treatment options.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) has announced that Dr. Todd C. Brady, President and CEO, will participate in a fireside chat at the SVB Securities Global Biopharma Conference, taking place virtually from February 14-16, 2023. Dr. Brady's discussion with Senior Research Analyst Marc Goodman is scheduled for 10:00 a.m. ET on February 16. Investors can watch the live webcast through Aldeyra's Investors & Media section and the event will be archived for 90 days. Aldeyra is focused on developing therapies for immune-mediated diseases, including potential treatments for dry eye disease and primary vitreoretinal lymphoma.

Aldeyra Therapeutics announced the acceptance of its New Drug Application (NDA) for topical ocular reproxalap by the FDA, with a PDUFA date of November 23, 2023.

The drug aims to address dry eye disease, a condition affecting over 39 million adults in the U.S. The NDA is backed by positive results from five clinical trials, indicating reproxalap's potential for rapid and durable effects. The drug has shown no significant safety concerns in more than 2,000 patients, though mild irritation at the application site was noted. Aldeyra is optimistic about the drug's efficacy and the unmet needs in dry eye disease treatment.

Aldeyra Therapeutics (NASDAQ: ALDX) announced the submission of a New Drug Application (NDA) for ADX-2191, a methotrexate injection for treating primary vitreoretinal lymphoma, a rare cancer with no approved therapy. This NDA is backed by safety data from the Phase 3 GUARD Trial, which showed ADX-2191 was well tolerated, with fewer adverse events compared to compounded methotrexate. The company has also requested Priority Review from the FDA to expedite the process. ADX-2191 also holds FDA Orphan Drug Designation, highlighting its potential significance in treating this condition.

Aldeyra Therapeutics (ALDX) reported promising results from a Phase 2 clinical trial of its investigational drug ADX-629, which showed significant reductions in dermal flushing (P=0.0007) and acetaldehyde levels (P=0.03), alongside improved balance (P=0.02) after alcohol exposure. The findings are particularly significant for patients with alcohol-associated liver diseases, where treatment options are limited. Aldeyra plans to initiate an investigator-sponsored Phase 2 trial for ADX-629 in moderate alcoholic hepatitis in 2023, further exploring its therapeutic potential.

Aldeyra Therapeutics plans to submit a New Drug Application (NDA) for ADX-2191 to treat primary vitreoretinal lymphoma by the end of 2022. The drug has received FDA Orphan Drug Designation and aims to be the first approved therapy for this rare condition, which has a median survival of less than five years. The NDA will include data from the Phase 3 GUARD Trial, which reported no significant safety concerns. Aldeyra also intends to request a Priority Review designation to expedite the FDA review process.

Aldeyra Therapeutics (NASDAQ: ALDX) has submitted a New Drug Application (NDA) to the FDA for its investigational drug reproxalap, targeting dry eye disease symptoms. This NDA is backed by data from five clinical trials, indicating efficacy and safety in over 2,000 patients, with minimal adverse effects noted. Reproxalap aims to be the first marketed RASP modulator for dry eye disease, a condition affecting over 39 million adults in the U.S. Additionally, reproxalap is in late-stage trials for allergic conjunctivitis, with results expected in 2023.