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Investing.com - Jefferies raised its price target on Aldeyra Therapeutics (NASDAQ:ALDX) to $7.00 from $6.00 while maintaining a Buy rating on the stock. According to InvestingPro data, analyst targets for ALDX range from $6.00 to $13.00, suggesting significant upside potential. The stock has already demonstrated strong momentum, surging nearly 192% over the past six months.
The FDA’s acceptance of Aldeyra’s resubmitted New Drug Application (NDA) for Reproxalap in dry eye disease represents a significant milestone for the company, according to Jefferies. InvestingPro analysis shows the company maintains strong financial health with a current ratio of 2.86, indicating ample liquidity to support its regulatory initiatives.
The resubmitted application now has a Prescription Drug User Fee Act (PDUFA) date of December 16, following previous Complete Response Letters (CRLs) from the regulatory agency.
Jefferies noted that Aldeyra’s latest Phase 3 trial met its primary endpoint and addressed the FDA’s previous concerns regarding baseline imbalance, which reduces regulatory risk for Reproxalap’s approval.
The firm views Aldeyra as a platform story with near-term upside potential, adding that AbbVie’s potential option exercise post-approval could drive additional value for the company.
In other recent news, Aldeyra Therapeutics has announced several significant developments. The U.S. Food and Drug Administration has granted fast track designation for Aldeyra’s drug ADX-2191, intended for treating retinitis pigmentosa, a rare genetic eye disease. This designation could expedite the development and review process for the drug. Additionally, the European Medicines Agency has granted Orphan Designation for ADX-2191 for treating inherited retinal dystrophies, including retinitis pigmentosa. In another update, the FDA has accepted Aldeyra’s resubmitted New Drug Application for reproxalap, a treatment for dry eye disease, with a PDUFA target action date set for December 16, 2025. Following this acceptance, Jones Trading raised its price target for Aldeyra to $9.00 from $6.00, maintaining a Buy rating. These developments highlight the ongoing progress in Aldeyra’s drug pipeline and regulatory advancements.
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