Bank of America just raised its EUR/USD forecast
On Friday, Jefferies analyst Kelly Shi revised the price target for Aldeyra Therapeutics (NASDAQ:ALDX) to $6.00, down from the previous $8.00, while continuing to endorse the stock with a Buy rating. The stock, currently trading at $1.79 with a market cap of $108.73 million, has seen significant pressure, falling nearly 79% in the past week. The adjustment follows a second Complete Response Letter (CRL) from the FDA regarding Aldeyra’s product candidate, Reproxalap, intended for dry eye treatment. InvestingPro data reveals 12 additional investment insights for ALDX.
Shi noted that the FDA’s CRL was not due to concerns about safety or manufacturing issues but was instead related to differences in patient baselines between treatment arms. The company views these differences as uncommon, but the FDA believes they could have influenced the interpretation of the data. Despite recent setbacks, Aldeyra maintains a strong financial position with a healthy current ratio of 5.59 and more cash than debt on its balance sheet. Aldeyra is currently conducting two additional symptom trials, with results anticipated in the second quarter of 2025, ahead of its next earnings report scheduled for May 1, 2025.
The company intends to resubmit its New Drug Application (NDA) in mid-2025, incorporating data from the new trials, pending discussions with the FDA. Shi’s commentary suggests that this development has led to a one-year delay in the potential approval timeline for Reproxalap.
Aldeyra Therapeutics is actively addressing the FDA’s feedback as it moves forward with additional trials. The outcome of these trials and subsequent discussions with the FDA will be crucial for the company’s efforts to obtain approval for Reproxalap. The updated price target reflects the latest regulatory setback and the adjusted expectations for the company’s path to market.
In other recent news, Aldeyra Therapeutics has faced a significant 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 highlighted the need for additional evidence of efficacy, prompting Aldeyra to plan for a resubmission of the NDA by mid-2025, contingent on positive trial results. The company has initiated several clinical trials to address the FDA’s concerns, with top-line results expected in the second quarter of 2025. Despite this hurdle, Aldeyra maintains a strong financial position with $101 million in cash and equivalents as of the end of 2024.
Analyst firms have shown varied responses to these developments. H.C. Wainwright reaffirmed a Buy rating with a $10 target, expressing confidence in the potential of reproxalap. Meanwhile, BTIG also maintained a Buy rating with a slightly higher target of $11, emphasizing the drug’s unique effectiveness and potential for a successful launch. The analysts noted the upcoming Prescription Drug User Fee Act (PDUFA) date in April as a critical milestone for Aldeyra.
Additionally, Aldeyra is advancing its pipeline with the development of ADX-248, an oral RASP inhibitor currently in Phase 1 trials. The company plans to present data later in 2025 and start a trial for atopic dermatitis. These recent developments underscore Aldeyra’s ongoing efforts to address regulatory challenges while continuing to innovate in the treatment of ocular and systemic diseases.
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