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Aldeyra's Dry Eye Drug Hits Another FDA Wall, Sending Shares Tumbling

MarketDash
Aldeyra Therapeutics stock is reeling after the FDA rejected its lead drug candidate for the third time, questioning its efficacy and leaving investors wondering what's next.

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Shares of Aldeyra Therapeutics Inc. (ALDX) are taking a beating, down sharply in premarket trading Thursday. The reason? The company just hit another major roadblock with the U.S. Food and Drug Administration for its experimental dry eye treatment, reproxalap. Since Tuesday, the stock has cratered by about 67%.

FDA Says 'Not So Fast'—Again

The company announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application for reproxalap. In regulatory speak, a CRL is basically a rejection, and this one pointed to a "lack of substantial evidence from controlled studies" to support approval.

Here's the twist: while the FDA raised concerns over the drug's efficacy and stated that further trials are not recommended, it did suggest the company could explore specific patient populations where reproxalap might work. That's a notable shift in tone from previous rejections.

Aldeyra's CEO emphasized in a statement the urgency of working with the FDA to find a path forward for what the company calls a potential breakthrough treatment. On the financial side, Aldeyra reported having $70 million in cash as of December 31, 2025, which it believes is enough to keep the lights on into 2028.

This Isn't Their First Rodeo

If this story sounds familiar, it's because it is. This marks the third time the FDA has sent a rejection letter for reproxalap.

Back in April 2025, the agency issued a CRL for a resubmitted application, stating it "failed to demonstrate efficacy in adequate and well-controlled studies" and that at least one more solid study was needed to show a positive effect on dry eye symptoms.

Go back even further to November 2023, and the initial NDA got a CRL that also requested at least one additional symptom trial. So, the efficacy question has been a persistent hurdle.

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The Technical Picture Is Ugly

Let's look at the charts, because they tell a story of pure pain for shareholders right now.

Aldeyra is currently trading a staggering 69.9% below its 20-day simple moving average and 71.2% below its 200-day average. That's the definition of a bearish trend. Over the past year, shares are down a brutal 78.42% and are hanging out much closer to their 52-week lows than highs.

The Relative Strength Index (RSI) is sitting at 20.25, which is deep in oversold territory. That often suggests a stock might be due for a bounce if any buyers show up. However, the MACD indicator tells a different story, with a value of -0.6382 and a signal line at -0.2362, indicating bearish momentum is still in control.

The takeaway? The stock is oversold, but the downward pressure hasn't necessarily let up. Technicians are watching key resistance at $4.50 and key support at $1.00.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating, but that's likely based on older data. The recent action tells a clearer story: HC Wainwright & Co. downgraded Aldeyra to Neutral from Buy on March 18 and lowered its price target to $2.00.

ALDX Stock Price Activity: According to market data, Aldeyra Therapeutics shares were down 2.09% at $1.39 during premarket trading on Thursday.

Aldeyra's Dry Eye Drug Hits Another FDA Wall, Sending Shares Tumbling

MarketDash
Aldeyra Therapeutics stock is reeling after the FDA rejected its lead drug candidate for the third time, questioning its efficacy and leaving investors wondering what's next.

Get Aldeyra Therapeutics Alerts

Weekly insights + SMS alerts

Shares of Aldeyra Therapeutics Inc. (ALDX) are taking a beating, down sharply in premarket trading Thursday. The reason? The company just hit another major roadblock with the U.S. Food and Drug Administration for its experimental dry eye treatment, reproxalap. Since Tuesday, the stock has cratered by about 67%.

FDA Says 'Not So Fast'—Again

The company announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application for reproxalap. In regulatory speak, a CRL is basically a rejection, and this one pointed to a "lack of substantial evidence from controlled studies" to support approval.

Here's the twist: while the FDA raised concerns over the drug's efficacy and stated that further trials are not recommended, it did suggest the company could explore specific patient populations where reproxalap might work. That's a notable shift in tone from previous rejections.

Aldeyra's CEO emphasized in a statement the urgency of working with the FDA to find a path forward for what the company calls a potential breakthrough treatment. On the financial side, Aldeyra reported having $70 million in cash as of December 31, 2025, which it believes is enough to keep the lights on into 2028.

This Isn't Their First Rodeo

If this story sounds familiar, it's because it is. This marks the third time the FDA has sent a rejection letter for reproxalap.

Back in April 2025, the agency issued a CRL for a resubmitted application, stating it "failed to demonstrate efficacy in adequate and well-controlled studies" and that at least one more solid study was needed to show a positive effect on dry eye symptoms.

Go back even further to November 2023, and the initial NDA got a CRL that also requested at least one additional symptom trial. So, the efficacy question has been a persistent hurdle.

Get Aldeyra Therapeutics Alerts

Weekly insights + SMS (optional)

The Technical Picture Is Ugly

Let's look at the charts, because they tell a story of pure pain for shareholders right now.

Aldeyra is currently trading a staggering 69.9% below its 20-day simple moving average and 71.2% below its 200-day average. That's the definition of a bearish trend. Over the past year, shares are down a brutal 78.42% and are hanging out much closer to their 52-week lows than highs.

The Relative Strength Index (RSI) is sitting at 20.25, which is deep in oversold territory. That often suggests a stock might be due for a bounce if any buyers show up. However, the MACD indicator tells a different story, with a value of -0.6382 and a signal line at -0.2362, indicating bearish momentum is still in control.

The takeaway? The stock is oversold, but the downward pressure hasn't necessarily let up. Technicians are watching key resistance at $4.50 and key support at $1.00.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating, but that's likely based on older data. The recent action tells a clearer story: HC Wainwright & Co. downgraded Aldeyra to Neutral from Buy on March 18 and lowered its price target to $2.00.

ALDX Stock Price Activity: According to market data, Aldeyra Therapeutics shares were down 2.09% at $1.39 during premarket trading on Thursday.