Announcement • Aug 28

Nicox S.A. Announces U.S. Food and Drug Administration Accepts the New Drug Application (NDA) for NCX 470

Nicox SA announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for NCX 470 (bimatoprost grenod; also known as K-911 in Kowa’s publications) for filing and set 30 April 2027 as the Prescription Drug User Fee Act (PDUFA) date for a response on review of the dossier. FDA acceptance confirms that the application is sufficiently complete for formal review and represents an important regulatory milestone toward potential approval. The NCX 470 NDA in the U.S. was submitted by Nicox’s exclusive U.S. licensee, Kowa, on June 30, 2026, and a milestone payment will be due upon approval. NCX 470 is a nitric oxide-donating bimatoprost eye drop for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. NCX 470 NDAs are now filed in two key markets, the U.S. and China. Subject to regulatory approval, Company has clear paths to commercialisation with company partners, Kowa and Ocumension, respectively. Both partners have established commercial organizations in place to support launch of NCX 470 swiftly after approval is granted. U.S. NDA approval triggers a milestone payment for Nicox, and royalties on sales would generate a new recurrent revenue stream. The NDA submission was based on positive results from the Mont Blanc and Denali Phase 3 clinical trials, which together were designed to meet regulatory requirements for efficacy and safety in support of approval in the United States and China. These trials demonstrated that NCX 470 achieved clinically meaningful reductions in IOP of up to 10mmHg with a favourable safety profile. Phase 3 clinical program in Japan: ongoing. U.S. FDA Decision: PDUFA date 30 April 2027. U.S. Launch: targeted in H2 2027, subject to FDA approval. NDA approval in China: NDA submitted August 2026. NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that leverages the potent intraocular pressure (IOP)-lowering effects of NO and prostaglandin analogs (PGAs). NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule. NCX 470 is designed to release bimatoprost and NO into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension. NO is a well-known small, naturally occurring signalling molecule that plays a key role in the regulation of IOP through activation of soluble guanylate cyclase (sGC). NO brings additional IOP-lowering efficacy by enhancing aqueous humor drainage from the eye via a different mechanism of action to that of PGAs. NCX 470 has completed two Phase 3 clinical trials, Mont Blanc and Denali, designed to fulfil the regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China. Both trials were positive and met the efficacy endpoints necessary for submission of a New Drug Application in the United States and China. NDAs for NCX 470 have been submitted in the U.S. and China. NCX 470 is an investigational product and has not yet been approved by the FDA.

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