Aldeyra Therapeu Stock Price, News & Analysis

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.

Aldeyra Therapeutics (ALDX) announced key developments and financial results for Q3 2022, with cash reserves exceeding $185 million. The NDA for Reproxalap for dry eye disease is on track for submission in Q4 2022, following an FDA pre-NDA meeting. The company also reported favorable results for ADX-2191 in clinical trials related to proliferative vitreoretinopathy, and plans upcoming NDA submissions for lymphoma. The net loss for the quarter was $14.6 million, an improvement from $15.8 million the previous year, with reduced R&D expenses.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will hold a conference call at 8:00 a.m. ET on November 10, 2022, to discuss financial results for the quarter ended September 30, 2022, and provide corporate highlights. Domestic callers can dial (844) 200-6205, and international callers can reach (929) 526-1599 with access code 048610. A live audio webcast will be available on the company's website and archived for 90 days.

Aldeyra Therapeutics (NASDAQ: ALDX) announced an upcoming oral presentation of clinical data from the Phase 3 INVIGORATE trial for reproxalap, designed to treat allergic conjunctivitis. Scheduled for October 26, 2022, at the American Academy of Optometry Annual Meeting in San Diego, the presentation will highlight clinically significant reductions in ocular itching and redness compared to a vehicle. Reproxalap is a first-in-class drug targeting reactive aldehyde species linked to ocular inflammation and is also in late-stage trials for dry eye disease.

Aldeyra Therapeutics (ALDX) announced that ADX-2191 achieved its primary endpoint in Part 1 of the Phase 3 GUARD Trial, demonstrating statistical superiority in preventing retinal detachment associated with proliferative vitreoretinopathy (PVR) (P=0.024). The trial involved 68 patients receiving ADX-2191 compared to 38 patients receiving routine surgical care. Notably, ADX-2191 was well tolerated with no significant safety concerns. The company plans discussions with the FDA regarding the completion of clinical development in the first half of 2023, aiming to address this rare disease's unmet medical needs.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will host a webcast on October 6, 2022, at 8:00 a.m. ET to report top-line results from Part 1 of the Phase 3 GUARD Trial for ADX-2191, an innovative treatment for proliferative vitreoretinopathy (PVR), a vision-threatening condition without available therapies. The conference call can be accessed via a dial-in number or through a live audio webcast on the company’s website, with archived access for 90 days post-event.