Welcome to our dedicated page for Onconetix news (Ticker: ONCO), a resource for investors and traders seeking the latest updates and insights on Onconetix stock.
Onconetix Inc. (ONCO) is a commercial-stage biotech innovator developing therapies for men's health and oncology. This page aggregates official news about FDA milestones, clinical research advancements, and strategic business developments.
Investors and industry observers will find verified updates on therapeutic innovations like the ENTADFI treatment for benign prostatic hyperplasia and progress in prostate cancer diagnostics. Our curation focuses on material events including regulatory submissions, trial results, and partnership announcements.
Key content categories include earnings reports, product launch updates, clinical trial phases, and acquisition activity. All information is sourced directly from company disclosures to ensure accuracy and timeliness.
Bookmark this page for streamlined access to Onconetix's latest developments in oncology diagnostics and therapeutic solutions. Check regularly for updates that may impact understanding of the company's market position and scientific progress.
Onconetix (NASDAQ:ONCO), a biotechnology company focused on men's health and oncology, has announced multiple significant financial transactions. The company has secured a $12.9 million private placement through Series D Preferred Stock and Warrants, with $9.3 million paid in cash and the remainder offsetting existing debts.
The financing includes warrants to purchase up to 4,362,827 shares of common stock at an initial exercise price of $3.6896 per share. Additionally, Onconetix has settled its $8.8 million debt with Veru, Inc. through a combination of $6.3 million cash payment and conversion of $2.5 million into Series D Preferred Stock and warrants. The company has also terminated its previously planned merger with Ocuvex, Inc.
Onconetix (NASDAQ:ONCO) and Ocuvex Therapeutics have mutually agreed to terminate their merger agreement originally announced on July 16, 2025. The decision comes after both companies determined that pursuing independent paths would better serve their respective stakeholders.
Despite the merger termination, Ocuvex announced positive developments, including obtaining its New Jersey state pharmaceutical license and the upcoming commercial launch of Omlonti in the coming weeks. Both companies' leadership expressed confidence in their independent growth trajectories and maintained a collaborative spirit throughout the process.
Onconetix (NASDAQ:ONCO) announced that its subsidiary Proteomedix has entered into a licensing agreement with Immunovia AB for the manufacturing of key reagents used in their pancreatic cancer test PancreaSure. Under the agreement, Proteomedix will provide master cells for antibody production and intellectual property licenses for three of the five biomarkers in PancreaSure.
The deal includes payments totaling $700,000 to Proteomedix in 2025-2026, plus a 3% royalty on net sales of PancreaSure and related products from 2026 to 2032. The agreement enables Immunovia to purchase reagents directly from Proteomedix's supplier while maintaining their focus on Proclarix, their early prostate cancer detection test.
Onconetix (NASDAQ:ONCO) and privately-held Ocuvex Therapeutics have signed a definitive merger agreement in a significant stock-based transaction. Under the terms, Ocuvex shareholders will receive 90% ownership of the combined company, while Onconetix shareholders will retain 10% of the equity interests.
The merger will combine Ocuvex's pipeline of commercial and late clinical stage ophthalmic assets with Onconetix's public market presence. The combined company's board will consist of seven directors, with Ocuvex designating five and Onconetix appointing two. The transaction is expected to close in Q4 2025, subject to regulatory and stockholder approvals.
Onconetix (NASDAQ: ONCO) has received multiple delisting notices from Nasdaq due to several compliance issues. The company faces delisting threats due to: (1) failure to file its Q1 2025 10-Q report, (2) failure to file its 2024 annual 10-K report, and (3) non-compliance with the minimum bid price requirement of $1.00, with shares trading below $0.10 for ten consecutive days.
The company has requested a hearing before the Nasdaq Hearings Panel scheduled for May 27, 2025, which has temporarily stayed the trading suspension. Onconetix has also submitted a stay request on May 1, 2025. The company intends to file both missing reports to regain compliance, though there's no assurance the Panel will grant extensions.
Onconetix (Nasdaq: ONCO) has received a Staff delisting letter from Nasdaq on April 24, 2025, due to failing to file its Annual Report (Form 10-K) for the fiscal year ended December 30, 2024. This violation follows a previous delisting notice from April 18, 2025, regarding non-compliance with the minimum bid price requirement of $1.00 per share.
The company has until May 1, 2025, to request a suspension stay, though approval isn't guaranteed. Onconetix, a commercial-stage biotechnology firm, specializes in men's health and oncology solutions. Their key products include:
- Proclarix® - An EU-approved in vitro diagnostic test for prostate cancer
- ENTADFI - An FDA-approved daily treatment combining finasteride and tadalafil for benign prostatic hyperplasia (BPH)
Onconetix (NASDAQ: ONCO) has signed a non-binding Letter of Intent for a potential business combination with Ocuvex Therapeutics, a private biopharmaceutical company specializing in ophthalmic therapeutics. The proposed transaction would result in Ocuvex shareholders owning approximately 90% of Onconetix's equity interests.
Ocuvex brings an FDA-approved product, Omlonti®, for ocular hypertension and open-angle glaucoma, along with late-stage clinical assets. Onconetix currently owns Proclarix®, an in vitro diagnostic test for prostate cancer approved in the EU, and ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia.
The transaction completion is subject to due diligence, definitive agreement execution, adequate financing, and regulatory and stockholder approvals. There is no guarantee the transaction will be completed as proposed.
Onconetix (NASDAQ: ONCO) has announced successful clinical validation results for its prostate cancer test Proclarix® in a Danish cohort, presented at the 2025 European Association of Urology congress. The study, involving 808 patients with suspected prostate cancer, demonstrated Proclarix's superior performance compared to traditional diagnostic methods.
In a subgroup of 371 patients with enlarged prostates, Proclarix® showed significantly better results than existing tools, with only 5% probability of missing clinically significant cancer, compared to 14% for %fPSA and 20% for the ERSPC risk calculator. The test reduced unnecessary biopsies by 22% while missing only 3 out of 101 significant cancers.
In the broader study group of 654 patients with PSA levels of 2-20 ng/ml, Proclarix® achieved 96% sensitivity and significantly higher specificity compared to current diagnostic tools.
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