Aldeyra Therapeutics Inc. (NASDAQ:ALDX) shares are down during Thursday’s premarket session following the company’s recent challenges with the FDA regarding its dry eye treatment.
Since Tuesday, the company’s stock has slumped by around 67%.
FDA Rejects Aldeyra Reproxalap Application
The company received an FDA Complete Response Letter (CRL) for its New Drug Application for reproxalap, indicating a lack of substantial evidence from controlled studies.
The FDA’s letter raised concerns over the efficacy of reproxalap, stating that further trials are not recommended, but suggested exploring specific populations where the drug may be effective.
In a statement, Aldeyra’s CEO emphasized the urgency of collaborating with the FDA to enable market access for reproxalap, which is viewed as a potential breakthrough treatment.
As of December 31, 2025, the company reported having $70 million in cash, which is expected to support operations into 2028.
Aldeyra Previous FDA Rejections
In April 2025, the FDA issued a Complete Response Letter for Aldeyra’s resubmission of the reproxalap application.
That time, the FDA stated that the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of a dry eye” should be conducted.
In November 2023, the FDA issued a Complete Response Letter to the initial NDA stating that at least one additional symptom trial was required.
ALDX Technical Analysis
Aldeyra Therapeutics is currently trading 69.9% below its 20-day simple moving average (SMA) and 71.2% below its 200-day SMA, indicating a bearish trend.
Shares have decreased 78.42% over the past 12 months and are positioned closer to their 52-week lows than highs.
The RSI is at 20.25, which is considered oversold, suggesting potential for a rebound if buying interest returns.
Meanwhile, the MACD shows a value of -0.6382, with the signal line at -0.2362, indicating bearish momentum as the MACD remains below the signal line.
The combination of an oversold RSI and bearish MACD suggests mixed momentum, indicating that while the stock is oversold, there is still downward pressure.
- Key Resistance: $4.50
- Key Support: $1.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating. Recent analyst moves include:
- HC Wainwright & Co.: Downgraded to Neutral (Lowers Target to $2.00) (March 18).
ALDX Stock Price Activity: Aldeyra Therapeutics shares were down 2.09% at $1.39 during premarket trading on Thursday, according to Benzinga Pro data.
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