ALDX Up as FDA Accepts Resubmitted NDA for Eye Drug Reproxalap [Yahoo! Finance]
Aldeyra Therapeutics, Inc. (ALDX)
Last aldeyra therapeutics, inc. earnings: 11/7 07:00 am
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Source: Yahoo! Finance
The company had previously received a complete response letter from the FDA in November 2023, but a subsequent phase III study met its primary endpoint, leading to the resubmission. Aldeyra has also expanded its option agreement with AbbVie, which could lead to a co-exclusive license to develop and commercialize reproxalap in the US and an exclusive license outside the US, with potential milestone payments of up to $300 million. Aldeyra Therapeutics, Inc. ALDX announced that the FDA has accepted its resubmitted new drug application (NDA) for reproxalap, a first-in-class investigational RASP modulator, for the treatment of the signs and symptoms of dry eye disease. With the FDA accepting the resubmitted NDA for review, a decision from the regulatory body is expected on April 2, 2025. Simultaneously, Aldeyra announced that it has expanded its existing option agreement with AbbVie ABBV. Shares of Aldeyra were up 11.6% on Nov. 18 following the announcement of the news. The stock h
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ALDX
News
- Is the Options Market Predicting a Spike in Aldeyra Therapeutics (ALDX) Stock? [Yahoo! Finance]Yahoo! Finance
- Aldeyra Therapeutics to Participate in the Citi 2024 Global Healthcare ConferenceBusiness Wire
- Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option AgreementBusiness Wire
- Aldeyra Therapeutics to Participate in the Jefferies London Healthcare ConferenceBusiness Wire
- Aldeyra Therapeutics Selected to Present at the Disruptive Innovations Symposium during the OSN New York Retina 2024 MeetingBusiness Wire
ALDX
Earnings
- 11/7/24 - In-Line
ALDX
Sec Filings
- 11/18/24 - Form 8-K
- 11/14/24 - Form SC
- 11/7/24 - Form 10-Q
- ALDX's page on the SEC website