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Investing.com - Jones Trading raised its price target on Aldeyra Therapeutics (NASDAQ:ALDX) to $9.00 from $6.00 on Friday, while maintaining a Buy rating following the FDA’s acceptance of the company’s New Drug Application (NDA) resubmission for reproxalap in dry eye disease. The stock has shown strong momentum, gaining over 7% in the past week, according to InvestingPro data.
The FDA has set a PDUFA date of December 16, 2025, for the reproxalap application, with AbbVie’s (NYSE:ABBV) option deadline falling ten business days after potential FDA approval, though Jones Trading expects a decision will likely happen before the holidays. InvestingPro analysis shows analyst targets ranging from $6 to $13, with a strong Buy consensus rating of 1.33.
The resubmission includes new clinical data from the dry eye chamber study conducted in May, addressing the baseline imbalances cited as a key issue in the Complete Response Letter (CRL) received in April.
Jones Trading noted that Aldeyra received FDA input on the chamber trial following the CRL, which should resolve methodological issues identified in the prior study, supporting the firm’s view that a positive chamber readout is sufficient for FDA approval.
The research firm increased its probability of success for reproxalap to 85% from 70% following the NDA acceptance, driving the price target increase along with other minor adjustments to its financial model.
In other recent news, Aldeyra Therapeutics has announced several significant developments. The European Medicines Agency has granted Orphan Designation for Aldeyra’s ADX-2191, intended for treating inherited retinal dystrophies, including retinitis pigmentosa. This condition affects over a million people worldwide and currently lacks approved drug treatments. Additionally, the U.S. Food and Drug Administration has accepted Aldeyra’s resubmitted New Drug Application for reproxalap, targeting dry eye disease, with a target action date set for December 16, 2025. The resubmission included data from a trial that successfully met its primary endpoint. Furthermore, Aldeyra has received a Special Protocol Assessment Agreement from the FDA for its investigational drug ADX-2191, aimed at treating primary vitreoretinal lymphoma (PVRL). The planned clinical trial will evaluate the effectiveness of different injection regimens of ADX-2191, with the study expected to start in the latter half of 2025. These developments mark significant progress in Aldeyra’s efforts to address unmet medical needs.
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