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Aldeyra Therapeutics Gains FDA Fast Track for ADX-2191

Story Highlights
  • Aldeyra Therapeutics received FDA Fast Track Designation for ADX-2191 for retinitis pigmentosa.
  • The designation could expedite ADX-2191’s development, addressing unmet needs in ophthalmology.
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Aldeyra Therapeutics Gains FDA Fast Track for ADX-2191

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

On August 19, 2025, Aldeyra Therapeutics announced that the FDA granted Fast Track Designation for ADX-2191, a methotrexate intravitreal injection, for treating retinitis pigmentosa, a rare genetic eye disease with no approved treatments. This designation, along with the previously granted Orphan Drug Designation, highlights the potential of ADX-2191 to address significant unmet needs in ophthalmology, supported by promising Phase 2 clinical trial results. A Phase 2/3 trial is planned for 2025, and the Fast Track status could expedite the drug’s development and review process, potentially benefiting over one million affected individuals worldwide.

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 modulate protein systems to optimize multiple pathways while minimizing toxicity, with product candidates including RASP modulators for systemic and retinal diseases, and late-stage candidates like reproxalap and ADX-2191 for eye-related conditions.

Average Trading Volume: 1,029,657

Technical Sentiment Signal: Buy

Current Market Cap: $322.8M

Learn more about ALDX stock on TipRanks’ Stock Analysis page.

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