Nicox Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan

Nicox's Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 for ocular hypertension in Japan, triggering a €2 million milestone payment to Nicox. This trial is part of the regulatory requirements for marketing approval in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox.

Nicox's Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 for ocular hypertension in Japan, triggering a €2 million milestone payment to Nicox. This trial is part of the regulatory requirements for marketing approval in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox [1].

The trial, which is part of the regulatory pathway for marketing NCX 470 in Japan, marks a significant step in the drug's development. The milestone payment is part of the financial arrangements agreed upon between Nicox and Kowa, which also includes an upfront payment of €7.5 million [2].

Nicox has been making steady progress in its clinical trials, with the last patient completing the NCX 470 Denali Phase 3 clinical trial in the U.S. and results expected by mid-August to mid-September 2025 [3]. Additionally, Nicox has extended its cash runway into Q4 2025, securing a flexible equity financing line with Vester Finance of up to 10 million shares over 24 months [4].

The company has also announced that the first commercial sale of ZERVIATE in China by partner Ocumension has created a new recurrent revenue stream [5]. These developments suggest that Nicox is well-positioned to continue its growth trajectory, particularly with the potential for NCX 470 to receive regulatory approval in Japan.

References:

[1] https://www.finanznachrichten.de/nachrichten-aktien/nicox-sa.htm
[2] https://www.globenewswire.com/news-release/17.07.2024/nicox-sa-nicox-and-kowa-sign-key-agreement-worth-up-to-e191-5-million-for-exclusive-rights-to-glaucoma-treatment-ncx-470-in-us-and-all-unlicensed-territories.html
[3] https://www.globenewswire.com/news-release/30.06.2024/nicox-sa-nicox-announces-last-patient-completes-the-ncx-470-denali-phase-3-clinical-trial.html
[4] https://www.globenewswire.com/news-release/06.03.2025/nicox-extends-cash-runway-into-q4-2025.html
[5] https://www.globenewswire.com/news-release/04.12.2024/nicox-sa-nicox-announces-first-commercial-sale-of-zerviate-in-china-by-partner-ocumension-creating-a-new-recurrent-revenue-stream.html