Aldeyra Therapeutics (ALDX) Stock News

Aldeyra Therapeutics (NASDAQ:ALDX) announced that its ADX-2191 (methotrexate intravitreal injection) has received Orphan Designation from the European Medicines Agency (EMA) for treating inherited retinal dystrophies, including retinitis pigmentosa. This designation follows a previous Orphan Drug Designation from the FDA.

The treatment targets retinitis pigmentosa, a rare genetic eye disease affecting over 1 million people worldwide with no currently approved drug treatments. A Phase 2 clinical trial in 2023 showed improvements in retinal sensitivity. The company plans to initiate a Phase 2/3 clinical trial in 2025.

The EMA's Orphan Designation provides benefits including reduced regulatory fees, clinical protocol assistance, research grants, and up to 10 years of market exclusivity in the EU.

Aldeyra Therapeutics (Nasdaq: ALDX) announced that the FDA has accepted its resubmitted New Drug Application (NDA) for reproxalap, a first-in-class drug candidate for dry eye disease treatment. The FDA has set a PDUFA target action date of December 16, 2025.

The NDA resubmission included results from an additional clinical trial that successfully met its primary endpoint of reducing ocular discomfort compared to vehicle control. Notably, reproxalap is positioned as the only dry eye disease investigational therapy demonstrating acute activity in reducing both ocular discomfort and redness in pivotal trials that simulate disease flares.

Aldeyra Therapeutics (NASDAQ:ALDX) has received a Special Protocol Assessment Agreement Letter from the FDA for ADX-2191, a novel methotrexate formulation designed for intraocular injection to treat primary vitreoretinal lymphoma (PVRL). The company plans to conduct a clinical trial comparing single versus eight intraocular injections in up to 20 patients, measuring cancer cell clearance after 30 days.

Following a Complete Response Letter in June 2023 stating insufficient literature evidence, the FDA has agreed that a single clinical trial plus literature references will support NDA resubmission. The trial is expected to begin in H2 2025 and conclude in 2026. ADX-2191 aims to provide a reduced injection volume compared to current off-label compounded methotrexate treatments for this rare and potentially fatal cancer.

Aldeyra Therapeutics (ALDX) has resubmitted its New Drug Application (NDA) to the FDA for reproxalap, a topical ocular treatment for dry eye disease. The resubmission follows an April 2025 Complete Response Letter from the FDA that requested additional symptom trial data due to methodological concerns. In May 2025, Aldeyra successfully completed a Phase 3 dry eye chamber trial, achieving the primary endpoint (P=0.002) in reducing ocular discomfort. The new trial showed no notable baseline differences across treatment arms and maintained a favorable safety profile, with mild and transient instillation site discomfort being the most common adverse event. The FDA's review process includes a 30-day acceptance review period and a 6-month review completion timeline under PDUFA guidelines.

Aldeyra Therapeutics (NASDAQ: ALDX), a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, has announced its participation in the upcoming 2025 Jefferies Global Healthcare Conference. Todd C. Brady, the company's President and CEO, will engage in a fireside chat with Clara Dong on June 5, 2025, at 4:20 p.m. ET in New York. The event will be accessible via live webcast through Aldeyra's investor relations website, and the recording will remain available for 90 days following the presentation.

Aldeyra Therapeutics (NASDAQ: ALDX) has announced positive results from its Phase 3 dry eye chamber trial for reproxalap ophthalmic solution. The trial achieved its primary endpoint, with reproxalap showing statistically significant superiority over vehicle (P=0.002) in reducing ocular discomfort. The company plans to resubmit its New Drug Application (NDA) to the FDA in mid-2025, following a Complete Response Letter received in April 2025. The new trial data, showing no notable baseline differences across treatment arms, potentially addresses the FDA's previous concerns. While a recent field trial was numerically supportive but didn't reach statistical significance, reproxalap has demonstrated both acute and chronic activity in reducing symptoms and is the first investigational drug showing pivotal data for acute activity in reducing ocular redness exacerbation. The drug has been studied in over 2,900 patients with a favorable safety profile.

Aldeyra Therapeutics (NASDAQ: ALDX) has scheduled a conference call and webcast for Tuesday, May 6, 2025, at 8:00 a.m. ET to present topline results from its Phase 3 clinical trials of reproxalap for dry eye disease. The event will be accessible to domestic callers at (833) 470-1428 and international callers at (404) 975-4839, using access code 127477. A live audio webcast will be available through the "Investors & Media" section of Aldeyra's website and will remain archived for 90 days after the event.

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.