Nicox Submits NDA to FDA for NCX 470 in Treating Ocular Hypertension

Regulation
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Summary · why it matters

Nicox has submitted a new drug application to the U.S. FDA for NCX 470 in the treatment of open-angle glaucoma and ocular hypertension. The submission was made via its U.S. licensee Kowa and triggered a €3 million milestone payment. NCX 470 is a novel nitric oxide-donating bimatoprost eye drop that demonstrated reduced intraocular pressure and a favorable safety profile in the Phase 3 Mont Blanc and Denali trials. The FDA review is expected to take up to a year, with a response anticipated by mid-2027 and a potential U.S. launch before the end of 2027. Kowa holds exclusive development and commercialization rights in the U.S., Japan, South Korea, and Southeast Asia, while Ocumension Therapeutics is the licensee in China.

Impact on stocks 3

Aging Population▲ · 2 stocks
KOWA CO. LTD.
7807
▲ PositiveRegulationrelevance

Kowa is the U.S. licensee that submitted the NDA; approval would enable commercialization in its licensed territories.

Ocumension Therapeutics 
1477
▲ PositiveRegulationrelevance

Ocumension is the licensee for China; NDA submission in the U.S. may support future regulatory progress in China.

Health Care▲ · 1 stocks
NicOx S.A.
ALCOX
▲ PositiveRegulationrelevance

Nicox is the originator; NDA submission triggers a €3M milestone and brings NCX 470 closer to potential U.S. approval.

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