Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in 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 clinical development plan intended to enable resubmission of a New Drug Application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease to the U.S. Food and Drug Administration (FDA). Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024. Contingent on positive results from the planned clinical trial, NDA resubmission is expected in the second half of 2024. Based on FDA guidance, the planned review period for the potential NDA resubmission is expected to be six months.“The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the sympto
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ALDX
Earnings
- 8/3/23 - Beat
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Sec Filings
- 4/25/24 - Form 8-K
- 4/25/24 - Form EFFECT
- 4/22/24 - Form ARS
- ALDX's page on the SEC website