Nicox Completes Key Data Generation for NCX 470 New Drug Applications

Nicox S.A., a French‑based ophthalmology biotechnology company listed on the NYSE and Euronext Paris, announced on 16 December 2025 that it has finished generating and analysing all key data required for the submission of New Drug Applications (NDAs) for its nitric‑oxide–donating candidate NCX 470 in the United States and China.

Key Points of the Announcement

  • Data Completion: All clinical trial results and long‑term stability data for both the active pharmaceutical ingredient and the finished drug product have been generated and analysed in compliance with International Council for Harmonisation (ICH) guidelines.
  • Regulatory Milestones:
  • A pre‑NDA meeting with the U.S. Food and Drug Administration (FDA) has been scheduled as a standard procedural step to confirm that the FDA will receive all necessary information.
  • The U.S. NDA submission is planned for the first half of 2026, aligning with the company’s timeline.
  • A comparable NDA submission in China is also on track for a 2026 filing.
  • Strategic Impact: Completion of these data sets positions Nicox to move forward with the regulatory filing process for NCX 470, a therapy designed to lower intraocular pressure in patients with glaucoma. The company’s pipeline includes several other ophthalmic candidates, such as Vyzulta™, NCX 4280, and NCX 4251, and it maintains collaborations with major industry partners including Bausch + Lomb, AstraZeneca, Merck, Pfizer, Ironwood Pharmaceuticals, and Novaliq GmbH.

Company Context

Nicox S.A. was founded in 1996 and is headquartered in Valbonne, France. With a market capitalisation of approximately €20.9 million, the company focuses on developing and marketing therapies for a range of eye conditions. Its product portfolio is broad, covering intraocular pressure reduction, nitric‑oxide donation for glaucoma, allergic conjunctivitis, ocular congestion, and blepharitis. The company’s shares are traded under the ticker ALCOX on both the NYSE and Euronext Growth Paris.

Financial Snapshot (as of 14 December 2025)

  • Closing Price: €0.2895
  • 52‑Week High: €0.65 (6 August 2025)
  • 52‑Week Low: €0.20 (6 April 2025)
  • Market Capitalisation: €20,986,561

The completion of NCX 470 data generation marks a significant regulatory milestone for Nicox, potentially advancing the company’s prospects in the competitive ophthalmology therapeutics market.