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Aldeyra Therapeutics Receives FDA Protocol Agreement for ADX-2191

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Aldeyra Therapeutics Receives FDA Protocol Agreement for ADX-2191

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Aldeyra Therapeutics ( (ALDX) ) has shared an announcement.

On June 26, 2025, Aldeyra Therapeutics announced that it received a Special Protocol Assessment Agreement Letter from the FDA for ADX-2191, an investigational drug for primary vitreoretinal lymphoma (PVRL), a rare and fatal cancer without FDA-approved treatment. The agreement allows Aldeyra to conduct a clinical trial comparing cancer cell clearance in patients receiving different injection regimens of ADX-2191. This development follows a previous Complete Response Letter from the FDA requiring more evidence for efficacy, and the trial is expected to begin in the second half of 2025, potentially impacting Aldeyra’s market positioning and offering a new treatment option for PVRL.

The most recent analyst rating on (ALDX) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Aldeyra Therapeutics stock, see the ALDX Stock Forecast page.

Spark’s Take on ALDX Stock

According to Spark, TipRanks’ AI Analyst, ALDX is a Underperform.

Aldeyra Therapeutics faces substantial financial and regulatory challenges, reflected in its low overall score. The lack of revenue and continuous losses are significant risks, compounded by negative technical indicators. The recent FDA response letter adds further uncertainty. However, strong cash reserves and a strategic board appointment provide some potential for recovery if product development succeeds.

To see Spark’s full report on ALDX stock, click here.

More about Aldeyra Therapeutics

Aldeyra Therapeutics is a biotechnology company focused on developing innovative therapies for immune-mediated and metabolic diseases. The company aims to optimize multiple pathways while minimizing toxicity through pharmaceuticals that modulate protein systems. Their product candidates include RASP modulators for systemic and retinal diseases, and late-stage candidates like reproxalap for dry eye disease and ADX-2191 for primary vitreoretinal lymphoma and retinitis pigmentosa.

Average Trading Volume: 1,851,666

Technical Sentiment Signal: Sell

Current Market Cap: $210.2M

For detailed information about ALDX stock, go to TipRanks’ Stock Analysis page.

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