MedPath

Reproxalap

Generic Name
Reproxalap
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C12H13ClN2O
CAS Number
916056-79-6
Unique Ingredient Identifier
F0GIZ22IJH
Background

Reproxalap (previously ADX 102 or NS-2) is a small molecule inhibitor being developed by Aldeyra Therapeutics investigated against dry eye disease, allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson syndrome. NS-2 has orphan drug status due to it being investigated for treatment of Sjogren-Larsson syndrome.

Associated Conditions
-
Associated Therapies
-
markets.ft.com
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Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug

Aldeyra Therapeutics announced the FDA accepted its resubmitted NDA for topical ocular reproxalap, targeting dry eye disease, with a PDUFA date of April 2, 2025. The company also expanded its option agreement with AbbVie, which could lead to a $100 million upfront payment and up to $300 million in milestone payments.
finance.yahoo.com
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Aldeyra Therapeutics Announces FDA Acceptance for Reproxalap NDA Resubmission

Aldeyra Therapeutics announced FDA's acceptance of the resubmitted NDA for reproxalap, targeting dry eye disease, with a PDUFA date of April 2, 2025. The company also expanded its option agreement with AbbVie, involving a $100 million upfront payment and up to $300 million in milestone payments, sharing profits 60/40. Reproxalap, a RASP modulator, has shown promise in treating dry eye disease and allergic conjunctivitis without significant safety concerns.

Aldeyra announces FDA acceptance for review of reproxalap for dry eye disease treatment

Aldeyra Therapeutics' NDA for reproxalap, a novel dry eye disease treatment, accepted by FDA with a PDUFA date of April 2, 2025. Expanded option agreement with AbbVie includes a $100M upfront payment and up to $300M in milestone payments, with a 60/40 profit split post-approval.
eyewire.news
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FDA Accepts Aldeyra's NDA for Reproxalap in Dry Eye Disease Treatment

Aldeyra Therapeutics' NDA for reproxalap, a dry eye disease treatment, accepted by FDA with a PDUFA date of April 2, 2025. Expanded agreement with AbbVie includes pre-commercial activities, cost-sharing, and potential $300M in milestone payments, highlighting commitment to therapy availability.

FDA Accepts Resubmitted NDA for DED Treatment, Expands AbbVie Option

Aldeyra Therapeutics' NDA for reproxalap, a dry eye disease treatment, was accepted by the FDA, with a review date set for April 2, 2025. The company expanded its option agreement with AbbVie, potentially leading to a $100 million upfront payment and up to $300 million in milestone payments, sharing profits 60/40.
investing.com
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FDA Reviews Aldeyra's Dry Eye Disease Drug Candidate

Aldeyra Therapeutics' NDA for reproxalap, a dry eye disease treatment, is under FDA review with a PDUFA date of April 2, 2025. A partnership with AbbVie could yield Aldeyra up to $400 million, including a $100 million payment upon FDA approval. Reproxalap targets RASP, showing promise in clinical trials. Aldeyra also advances other RASP modulators for various diseases.

Aldeyra says FDA accepts reproxalap NDA, AbbVie deal expanded to $100M

Aldeyra Therapeutics' NDA for reproxalap, a dry eye disease treatment, was accepted by the FDA, with a PDUFA date of April 2, 2025. The company expanded its option agreement with AbbVie, which could lead to a $100M upfront payment and up to $300M in milestone payments, sharing profits 60/40. Pre-commercial activities will be jointly funded.
finance.yahoo.com
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ALDX Up as FDA Accepts Resubmitted NDA for Eye Drug Reproxalap

Aldeyra Therapeutics' FDA-accepted NDA resubmission for reproxalap targets dry eye disease, with a decision expected by April 2, 2025. Following a 2023 CRL, a phase III study met primary endpoints, leading to the resubmission. Aldeyra also expanded its option agreement with AbbVie, sharing pre-commercial costs. Shares rose 11.6% post-announcement.
healio.com
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Aldeyra resubmits reproxalap NDA for treatment of dry eye

Aldeyra Therapeutics resubmitted a new drug application for reproxalap, aiming to treat dry eye disease. Reproxalap could be the first chronic-use therapy for dry eye, showing potential in reducing symptoms and ocular redness. The resubmission includes positive trial results and a draft label highlighting acute and chronic improvements.
defenseworld.net
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American Century Companies Inc. Acquires 36,528 Shares of Aldeyra Therapeutics, Inc

American Century Companies Inc. increased its holdings in Aldeyra Therapeutics by 216.7% in Q2. Several other institutional investors also adjusted their positions. HC Wainwright maintained a 'buy' rating with a $10.00 target price. ALDX stock opened at $5.34 on Friday, with a market cap of $317.27 million.
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