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LEXINGTON, Mass. - Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), a clinical-stage biotech company with a market capitalization of $211 million, has received a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration for its investigational drug ADX-2191, a novel formulation of methotrexate designed for intraocular injection to treat primary vitreoretinal lymphoma (PVRL). InvestingPro data shows the company maintains a strong financial position, with more cash than debt on its balance sheet and a healthy current ratio of 6.49x.
PVRL is a rare and potentially fatal retinal cancer diagnosed in approximately 300 to 600 U.S. patients annually, with a median survival of less than five years. Currently, no FDA-approved treatments exist for this condition. The market opportunity has caught analysts’ attention, with InvestingPro reporting that three analysts have recently revised their earnings estimates upward for the upcoming period. The stock has shown strong momentum, gaining over 10% in the past week.
The clinical trial outlined in the agreement will compare cancer cell clearance in up to 20 patients randomized to receive either a single intraocular injection or eight intraocular injections of ADX-2191. The study is expected to begin in the second half of 2025 and conclude in 2026. With analyst price targets ranging from $6 to $11 per share, investors seeking deeper insights into Aldeyra’s potential can access 9 additional exclusive ProTips and comprehensive financial analysis through InvestingPro.
This development follows Aldeyra’s previous attempt to secure approval for ADX-2191. The company submitted a literature-based New Drug Application in 2023, which received Priority Review but was ultimately rejected when the FDA determined that the available literature was insufficient to demonstrate efficacy.
The FDA has now agreed that a single clinical trial, in addition to literature references, will be sufficient to support a new application. ADX-2191 has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.
According to the press release statement, ADX-2191 is specifically designed for intraocular injection and potentially allows for reduced injection volume compared to currently used compounded methotrexate formulations, which represent the current standard of care despite lacking FDA approval.
In other recent news, Aldeyra Therapeutics has resubmitted its New Drug Application (NDA) for reproxalap to the U.S. Food and Drug Administration, following a successful Phase 3 trial addressing previous FDA concerns. The trial achieved its primary endpoint with statistical significance in reducing ocular discomfort, a key symptom of dry eye disease. Despite this progress, Aldeyra received another Complete Response Letter from the FDA, indicating the application cannot be approved in its current form. Analysts from Laidlaw and H.C. Wainwright maintain a Buy rating on Aldeyra, highlighting potential upside despite regulatory setbacks. BTIG and Jefferies analysts have adjusted their price targets for the company to $9 and $6, respectively, while still endorsing a Buy rating. These adjustments reflect the FDA’s cautious stance on reproxalap, particularly concerning baseline differences in trial data. Aldeyra is conducting additional trials to address these issues and plans to resubmit its NDA by mid-2025. The outcome of these trials and subsequent FDA discussions will be crucial for the approval process.
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