OncoSil shares surge following TGA cancer device approval
Australian medical technology company OncoSil Medical (ASX:OSL) has secured a major regulatory breakthrough, with the Therapeutic Goods Administration approving its OncoSil Class III medical device for commercialisation.
The decision saw the company's share price rose by 33.33%, reflecting strong investor optimism.
The TGA has greenlit the device for inclusion on the Australian Register of Therapeutic Goods to treat patients suffering from unresectable, locally advanced pancreatic cancer when paired with gemcitabine-based chemotherapy.
With Australia recording approximately 4,353 new pancreatic cancer cases annually, management views this milestone as a critical pathway towards widespread clinical adoption and a vital commercial gateway.
To meet the anticipated demand, OncoSil is scaling its manufacturing capabilities. The company is nearing completion of a new production facility in Macquarie Park, Sydney, developed in partnership with Cyclotek.
This facility, which recently completed its first radioactive production run, is designed to fortify the company's supply chain during this domestic expansion.
The regulatory triumph caps off a first half for the 2026 financial year, during which OncoSil reported record dose sales and cash receipts, alongside progress in European markets.
The firm is backed by an 8 million dollar capital raise executed in February, complemented by a recent 1.84 million dollar research and development tax incentive refund.
CEO Nigel Lange agreed to a 10% salary reduction, converting the foregone cash into ordinary shares.
At the time of reporting, OncoSil Medical’s share price was $0.52.
