Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease
Aldeyra Therapeutics, Inc. (ALDX)
Last aldeyra therapeutics, inc. earnings: 11/7 07:00 am
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Source: Business Wire
LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. The resubmission includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.“If approved, reproxalap would have the potential to be the first dry eye disease the
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- ALDX Up as FDA Accepts Resubmitted NDA for Eye Drug Reproxalap [Yahoo! Finance]Yahoo! Finance
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ALDX
Earnings
- 11/7/24 - In-Line
ALDX
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- 11/18/24 - Form 8-K
- 11/14/24 - Form SC
- 11/7/24 - Form 10-Q
- ALDX's page on the SEC website