Reproxalap

Oppenheimer maintains an Outperform rating for Aldeyra Therapeutics, optimistic about Reproxalap's potential in treating dry eye disease. The drug's rapid action and unique mechanism could drive patient adoption and favorable insurance coverage. Aldeyra anticipates a PDUFA date for Reproxalap on April 2, 2025, with strong financial health and market potential.

BTIG analyst Thomas Shrader maintains a Buy rating on Aldeyra Therapeutics (ALDX) with a $11.00 target, citing positive prospects for its lead product Reproxalap. Reproxalap shows promise for Dry Eye Disease and Allergic Conjunctivitis, with a strategic partnership with AbbVie enhancing its market potential. Existing treatments' challenges offer Reproxalap a chance to capture market share.

Astellas Pharma received a Complete Response Letter from the FDA for avacincaptad pegol, while Aldeyra Therapeutics' topical reproxalap for dry eye disease had its NDA accepted. Dr. Valerie Biousse discussed the benefits of non-mydriatic fundus cameras in emergency departments, enabling remote diagnosis and reducing ED length of stay. Dr. Jonathan Brugger highlighted the correlation between energy drink consumption and retinal vein occlusions in young adults.

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY) due to a statistical matter; Aldeyra Therapeutics' NDA for reproxalap for dry eye accepted by FDA; case report on carotid-cavernous fistula misdiagnosed as allergies; AAOpt 2024 discusses genetic testing; study links long-term blood pressure variability to visual field progression in glaucoma.

The FDA accepted Aldeyra Therapeutics' resubmitted NDA for topical reproxalap, a first-in-class candidate for dry eye disease. Aldeyra expanded its option agreement with AbbVie, receiving $100 million upfront and potential $300 million in milestone payments. The NDA includes positive Phase 3 trial results, and the PDUFA date is set for April 2, 2025.

FDA accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a dry eye disease treatment, and expanded its option agreement with AbbVie, including a $100M upfront payment and up to $300M in milestone payments. A PDUFA date is set for April 2, 2025.

Aldeyra Therapeutics announced FDA acceptance of its NDA for reproxalap, a dry eye disease treatment, with a PDUFA date of April 2, 2025. The company also expanded its option agreement with AbbVie, which could pay Aldeyra up to $400 million upon FDA approval.

Aldeyra Therapeutics announces FDA acceptance for review of reproxalap NDA for dry eye disease, with a PDUFA date of April 2, 2025. The company expands its option agreement with AbbVie, which includes potential milestone payments up to $300 million. Reproxalap is a first-in-class small-molecule modulator of RASP, studied in over 2,500 patients with no significant safety concerns.

FDA accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a dry eye disease treatment, with a PDUFA date of April 2, 2025. Reproxalap, a first-in-class RASP modulator, showed efficacy in reducing ocular discomfort in a phase 3 trial. The drug has been studied in over 2,500 patients with mild adverse events. Aldeyra also conducted a phase 3 trial for reproxalap in allergic conjunctivitis, showing decreased ocular symptoms and redness.

Aldeyra Therapeutics' resubmitted NDA for topical ocular reproxalap, targeting dry eye disease, was accepted by the FDA with a PDUFA date of April 2, 2025. The company expanded its option agreement with AbbVie, which could pay Aldeyra $100 million upfront, less $6 million in option fees, and up to $300 million in milestone payments. If the option is exercised, AbbVie would share 60% of U.S. profits and losses, with Aldeyra receiving 40%.