Aldeyra Therapeu Stock Price, News & Analysis

Aldeyra Therapeutics (NASDAQ:ALDX), a biotechnology company focused on immune-mediated and metabolic diseases, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The company's President and CEO, Todd C. Brady, M.D., Ph.D., will engage in a fireside chat with Matthew Caufield, Director of Equity Research at H.C. Wainwright & Co.

The presentation is scheduled for September 8, 2025, at 11:30 a.m. ET. Investors can access the live webcast through Aldeyra's investor relations website, and the recording will be available for 90 days following the event.

Aldeyra Therapeutics (Nasdaq: ALDX) has received Orphan Designation from the European Medicines Agency (EMA) for ADX-2191, a novel intravitreal methotrexate injection designed to treat primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma.

The rare cancer affects 100-200 people annually in the European Union and currently has no approved treatment. A planned clinical trial, approved via Special Protocol Assessment, will evaluate cancer cell clearance in up to 20 patients, comparing single versus eight intraocular injections of ADX-2191. The trial is set to begin in H2 2025 and conclude in 2026.

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

Aldeyra Therapeutics (NASDAQ:ALDX) has received FDA Fast Track designation for ADX-2191, its intravitreal methotrexate injection treatment for retinitis pigmentosa. This rare genetic eye disease, affecting over 1 million people worldwide, currently has no approved treatments for most forms.

The designation follows positive Phase 2 clinical trial results announced in 2023, which showed improvements in retinal sensitivity. Aldeyra plans to initiate a Phase 2/3 clinical trial in 2025. The Fast Track status, combined with previous Orphan Drug Designation, enables frequent FDA interactions and potential expedited review processes.

Aldeyra Therapeutics (NASDAQ:ALDX), a biotechnology company focused on immune-mediated and metabolic diseases, has announced its participation in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference. The company's President and CEO, Todd C. Brady, M.D., Ph.D., will engage in a fireside chat with Matthew Caufield, Director of Equity Research at H.C. Wainwright & Co., on August 13, 2025, at 10:30 a.m. ET. The discussion will be accessible via webcast through Aldeyra's investor relations website and will remain available for 90 days after the event.

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.