Onconetix Reports Q1 2026 Progress at Proteomedix AG, Including Two New Peer-Reviewed Publications and Initiation of U.S. Validation Study
Rhea-AI Summary
Onconetix (Nasdaq: ONCO) reported Q1 2026 progress at subsidiary Proteomedix, developer of the Proclarix® blood test for clinically significant prostate cancer. Two new peer-reviewed publications from Danish studies support Proclarix® in reducing overdiagnosis and unnecessary biopsies and in predicting transition from active surveillance to treatment.
According to Onconetix, PMX also initiated the U.S. multi-center PRIME validation study with Labcorp, targeting up to 500 men, and expanded European use, including a UK screening initiative and a new collaboration partner in Turkey.
Positive
- Two peer-reviewed studies support Proclarix® diagnostic and prognostic performance
- Clinical study in 371 men showed reduced overdiagnosis and unnecessary biopsies
- Study in 132 men under active surveillance showed prognostic value of Proclarix® risk score
- PRIME U.S. multi-center validation study with Labcorp initiated, up to 500 men
- Proclarix® included in UK real-world prostate cancer screening initiative
- New collaboration partner identified to support Proclarix® entry into Turkey
Negative
- None.
News Market Reaction – ONCO
In the May 13 session, ONCO declined 5.10%, reflecting a notable negative market reaction. Argus tracked a peak move of +11.0% during that session. Argus tracked a trough of -5.1% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 09 | AI acquisition update | Positive | +8.0% | Highlighted Realbotix Vinci AI robot delivery to Ericsson and pending acquisition. |
| Apr 02 | AI delivery update | Positive | -18.9% | Disclosed timetable for 19 humanoid robot deliveries and acquisition progress. |
| Mar 31 | Management changes | Positive | -5.1% | Appointed new CEO and director linked to advancing Realbotix acquisition. |
| Mar 25 | 6G trial showcase | Positive | +5.7% | Featured Realbotix humanoid in Ericsson’s 6G trial and reiterated share exchange. |
| Mar 23 | Reverse stock split | Negative | -3.0% | Announced 1-for-5 reverse split to help satisfy Nasdaq bid price rules. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news often ties to the Realbotix acquisition and capital structure; price reactions have been mixed, with both rallies and sharp selloffs on AI-related updates and structural actions.
Over the last few months, ONCO has shifted focus toward its planned acquisition of Realbotix, with multiple AI‑themed updates on humanoid robots and a definitive share exchange agreement. Governance changes, including a new CEO and board adjustments on March 18–19, 2026, supported this pivot. A 1‑for‑5 reverse split effective March 25, 2026 aimed to address listing requirements. Against this backdrop, the current Proclarix® clinical and commercial progress at Proteomedix highlights the legacy diagnostics business alongside ONCO’s evolving AI narrative.
Key Terms
ce-ivd regulatory
psa medical
prostate-specific antigen medical
clinically significant prostate cancer medical
active surveillance medical
multi-center medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
New Clinical Data Reinforce Proclarix® Performance in Reducing Overdiagnosis and Unnecessary Biopsies; Multi-Center PRIME Study Initiated in Collaboration with Labcorp; European Commercial Expansion Advances
CINCINNATI, Ohio, May 13, 2026 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) today provided an update on the Q1 2026 operational progress of its fully-owned Swiss subsidiary, Proteomedix AG (“PMX”), developer of Proclarix®, a CE-IVD certified diagnostic blood test used in combination with PSA (prostate-specific antigen) to identify clinically significant prostate cancer (“csPCa”).
Prostate cancer is the most frequently diagnosed male cancer in most countries globally and represents a significant burden to patients and healthcare systems. Proclarix® is designed to support clinicians in distinguishing clinically significant from clinically insignificant prostate cancer at an early stage, reducing unnecessary biopsies and overdiagnosis.
New Peer-Reviewed Clinical Publications
Two new peer-reviewed scientific publications from a recent clinical study conducted in Denmark further reinforce the clinical utility of Proclarix®.
The first paper, by Schiess et al., has been accepted for publication in BMC Cancer, a renowned open-access oncology research journal. The study evaluated Proclarix® in a cohort of 371 men and demonstrated its superior performance in ruling out clinically insignificant or absent prostate cancer while maintaining a low risk of missing csPCa. Proclarix® was shown to significantly reduce overdiagnosis and unnecessary biopsies, outperforming both %fPSA and the ERSPC risk calculator.
The second paper, by Athanasiou et al., has been published in the journal Cancers (2026, 18, 1348–62). In a cohort of 132 men under active surveillance, the study demonstrated the prognostic value of Proclarix® and its risk score in predicting the transition of patients from active surveillance to active treatment.
PRIME Study Initiated with Labcorp
To evaluate Proclarix® in the U.S. market and across various ethnicities, PMX has initiated the PRIME study, a multi-center clinical validation study conducted in collaboration with Labcorp Holdings Inc. The first participants have been enrolled, and the study is designed to ultimately include up to 500 men.
European Commercial Expansion
PMX continued to advance its commercial presence across Europe during Q1 2026. In the United Kingdom, Proclarix® is now offered by a patient organization as an additional option within a real-world screening initiative for early identification of prostate cancer. Close to 100 Proclarix® tests were carried out within this initiative in Q1 2026 alone.
PMX has also identified a collaboration partner in Turkey and continues its efforts to expand market reach into additional European countries.
About Onconetix, Inc.
Onconetix, Inc. (Nasdaq: ONCO) is a commercial-stage biotechnology company focused on the research, development, and commercialization of innovative oncology solutions. Onconetix owns Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the IVDR, which it anticipates will be marketed in the U.S. as a lab developed test through its license agreement with Labcorp. For more information, visit www.onconetix.com.
About Proteomedix AG
Proteomedix AG (PMX) is a fully owned Swiss subsidiary of Onconetix, Inc. focused on the development and commercialization of innovative diagnostic solutions for prostate cancer. PMX developed Proclarix®, a CE-IVD certified diagnostic blood test that, when used in combination with PSA, supports the early identification of clinically significant prostate cancer. PMX is headquartered in Switzerland. For more information, visit www.proteomedix.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Onconetix’s current expectations and actual results could differ materially. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K filed with the SEC on March 13, 2026, and periodic reports filed with the SEC on or after the date thereof. All forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. Onconetix does not undertake an obligation to update or revise any forward-looking statement except as required by applicable law.
Investor and Media Contact:
Onconetix, Inc.
201 E. Fifth Street, Suite 1900
Cincinnati, OH 45202
Phone: (513) 620-4101
Email: investors@onconetix.com
