Onconetix, Inc. (Nasdaq: ONCO) and Ocuvex Therapeutics, Inc. announced the mutual termination of their definitive merger agreement on September 26, 2025, just two months after the initial agreement was signed on July 16, 2025. The decision comes as both companies determined that pursuing independent paths would better serve their respective stakeholders and therapeutic missions.
Strategic Pivot Enables Independent Growth
After careful consideration and constructive dialogue, both biotechnology companies concluded that maintaining separate operations would optimize their ability to deliver value to patients, partners, and investors. The termination reflects each company's commitment to advancing their distinct therapeutic focuses without the complexities of integration.
Anthony Amato, CEO of Ocuvex, emphasized that the decision would not impact the company's operational momentum. "The decision to mutually terminate the merger agreement does not impact Ocuvex's momentum or our commitment to patients," Amato stated. "We are excited to announce that Ocuvex has received its New Jersey state pharmaceutical license, and the commercial launch of Omlonti will commence in the coming weeks."
Omlonti Launch Proceeds as Planned
The termination coincides with a significant milestone for Ocuvex, which has secured its New Jersey state pharmaceutical license, clearing a crucial regulatory hurdle for commercialization. The company confirmed that Omlonti, its ophthalmic therapeutic, will launch commercially within weeks of the announcement.
Amato further noted that Ocuvex's pipeline continues to advance beyond Omlonti, with the company maintaining its focus on delivering innovative ophthalmic solutions to the market. The independent path allows Ocuvex to concentrate fully on its core competency in eye health therapeutics.
Mutual Respect Despite Separation
Andrew Oakley, Chairman of the Board of Onconetix, expressed continued confidence in Ocuvex's prospects despite the companies' decision to separate. "Ocuvex is an innovative company with a strong commitment to advancing eye health," Oakley commented. "Despite our decision to part ways, we are confident that Omlonti will deliver value for patients and the ophthalmic community upon launch and future growth."
Both organizations acknowledged the collaborative spirit and professionalism demonstrated throughout the merger discussions, indicating that the termination was amicable and strategic rather than contentious.
Company Profiles and Strategic Focus
Onconetix operates as a commercial-stage biotechnology company focused on innovative solutions for men's health and oncology. Through its acquisition of Proteomedix, the company owns Proclarix®, an in vitro diagnostic test for prostate cancer that received approval for sale in the European Union under the IVDR.
Ocuvex Therapeutics positions itself as a leader in ophthalmic innovation, dedicated to advancing ophthalmic science and improving patient outcomes through innovative research and product development. The company's focus on eye health therapeutics represents a distinct market segment from Onconetix's men's health and oncology portfolio.
The mutual termination allows both companies to allocate resources and management attention to their core therapeutic areas without the distractions and integration challenges that mergers typically present.
