Aldeyra Therapeutics' Resubmitted Marketing Application for Eye Disease Drug Accepted by FDA

MT Newswires Live11-18

Aldeyra Therapeutics (ALDX) said Monday that the US Food and Drug Administration has accepted its resubmitted new drug application for its topical ocular reproxalab, a treatment for dry eye disease.

The company said the FDA has assigned a Prescription Drug User Fee Act date of April 2.

Aldeyra has also expanded its option agreement with AbbVie (ABBV), which was entered into in October and could give the latter a co-exclusive license to develop, manufacture and commercialize the drug candidate in the US.

If AbbVie exercises the option, Aldeyra will receive a $100 million upfront payment, plus up to $300 million in milestone payments.

The company said it would share profits from the commercialization of reproxalap in the US under a split of 60% for AbbVie and 40% for Aldeyra.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment