Latest Manufacturing Agreements News

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Lumos Diagnostics has entered a three-year contract manufacturing agreement with Micro-Pak to produce the Mold Analyzer system, marking a transition from development to commercial-scale manufacturing with an initial US$250,000 purchase order.

Bioxyne Ltd has secured a manufacturing agreement with global cannabis giant Aurora Cannabis, marking a major step in its international expansion of pharmaceutical-grade medicinal cannabis products.

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Aquirian Limited has bolstered its growth trajectory with a $20 million Mt Ida contract and significant advancements in its patented Collar Keeper® system, alongside commissioning its Wubin facility.

Peak Processing Limited has renewed and expanded its manufacturing agreement with Electric Brands, securing an expected annual production of approximately 1.4 million Sweet Justice cannabis beverage units. This deal reinforces Peak’s position in North America’s regulated cannabis beverage market and supports growth in Canada and the US.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing for its lead ophthalmology product, Elate Ocular®, alongside key global partnerships and a $2.4 million capital injection from a major shareholder.

Epsilon Healthcare’s subsidiary, Epsilon Pharma, has signed a three-year manufacturing agreement with New Zealand’s Puro to supply medicinal cannabis products to the UK and Europe, marking a significant step in its international expansion.

Rhythm Biosciences has secured a multi-year commercial manufacturing agreement with US-based Quansys Biosciences to produce ColoSTAT® reagent kits, paving the way for broader market rollout of its colorectal cancer diagnostic test.

Peak Processing Limited has completed a strategic rebrand and organisational restructure, securing new long-term manufacturing agreements and expanding product listings to strengthen its foothold in North America's regulated cannabis beverage markets.