Stock market today: S&P 500 drops for fifth day as focus shifts to Powell’s speech
On Monday, BTIG analyst Thomas Shrader revised the price target for Aldeyra Therapeutics (NASDAQ:ALDX) shares, reducing it to $9.00 from the previous $11.00, while maintaining a Buy rating on the stock. The revision comes as the stock has experienced significant pressure, falling over 67% in the past week to $1.89, though InvestingPro data shows analyst targets still range from $6 to $11. Shrader’s adjustment follows a cautious stance from the FDA regarding Aldeyra’s drug Reproxalap, used to treat patients with Dry Eye Disease (DED). Despite recent challenges, InvestingPro analysis reveals the company maintains a strong liquidity position with a current ratio of 5.59 and more cash than debt on its balance sheet.
The FDA’s reservation stems from an imbalance in baseline ocular discomfort scores observed in the most recent chamber trial for Reproxalap. Despite several trials indicating the drug’s activity, the FDA focused on this imbalance, suggesting the difference in starting scores could have been carried over from pre-trial conditions. Shrader pointed out that the FDA’s strict interpretation of these results reflects the agency’s cautious approach.
Aldeyra Therapeutics is close to completing two additional trials aimed at demonstrating Reproxalap’s effectiveness in alleviating DED symptoms. One is another chamber trial designed to address any potential baseline issues, and the other is a field trial where patients report ocular discomfort over time in a natural environment, not an artificially irritating chamber.
The company anticipates meeting with the FDA in about 30 days to discuss the new trials and plans to resubmit to the FDA by mid-2025. If the resubmission is successful, approval for Reproxalap could occur towards the end of 2025. Shrader’s commentary suggests that these upcoming trials could clarify the efficacy of Reproxalap and potentially lead to its approval despite the FDA’s current conservative position. With a market capitalization of $112.85 million and oversold RSI levels, InvestingPro subscribers can access 12 additional investment tips and detailed financial metrics to better evaluate the company’s potential.
In other recent news, Aldeyra Therapeutics has faced a setback with the U.S. Food and Drug Administration (FDA) issuing a Complete Response Letter (CRL) for its New Drug Application (NDA) for reproxalap, a treatment for dry eye disease. The FDA’s letter indicated that the application did not demonstrate efficacy in well-controlled studies, highlighting concerns over methodological issues. Despite this, Aldeyra plans to resubmit the NDA by mid-2025, pending positive results from ongoing trials and further discussions with the FDA. Analysts have weighed in on these developments, with Laidlaw maintaining a Buy rating and a price target of $11.00, emphasizing the potential upside despite the regulatory hurdle. Jefferies, however, revised its price target to $6.00 from $8.00, while still endorsing the stock with a Buy rating. H.C. Wainwright also reiterated a Buy rating with a $10.00 price target, showing confidence in reproxalap’s potential. Aldeyra has reported a solid financial standing with $101 million in cash and marketable securities as of the end of 2024. The company remains optimistic about the future, with top-line results from ongoing trials expected in the second quarter of 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.