Shares in ASX-listed biotech Argent Biopharma (ASX:RGT) have seen renewed momentum following the announcement that its lead epilepsy treatment, CannEpil®, is now approved for prescription in Germany under the country’s Special Access Scheme.
CannEpil is a high-CBD, low-THC oral treatment developed for patients with drug-resistant epilepsy. According to the company, the formulation is designed to support individuals who do not respond to conventional anti-epileptic therapies. With Germany representing one of Europe’s largest pharmaceutical markets, the development marks a significant milestone in the company’s attempt to commercialise the product internationally — and potentially unlock meaningful revenue streams.
Argent Biopharma holds a patent for CannEpil’s Self-Nanoemulsifying Drug Delivery System (SNEDDS), which it says improves the bioavailability and stability of the active compounds. This intellectual property could provide the company with a defensible competitive edge in a growing cannabinoid therapeutics space.
Following the German announcement shares in ASX:RGT rose, with trading volumes increasing over the following sessions. This rally has drawn attention to what some investors view as a significant undervaluation relative to the company’s evolving commercial profile.
A report from the Edison Group, cited by the company, assigned CannEpil a valuation of USD 327 million. That figure is based on the product’s potential in global markets, particularly in jurisdictions with large epilepsy populations and established regulatory frameworks for cannabinoid-based therapies. Although such valuations are forward-looking and indicative, they reflect the scale of opportunity Argent Biopharma is beginning to access.
In Germany, CannEpil is now accessible to doctors through prescription. The product falls under Germany’s existing special access framework for cannabinoid medicines, making it one of the few ASX-listed biotech assets with real-world patient availability. The company has also expressed intentions to pursue approvals in additional European jurisdictions and in Australia — potentially creating further catalysts for the share price if regulatory progress continues.
With the German development now public, attention has turned to how the company might scale its operations and whether it will seek further partnerships or funding to support expansion. Investors will also be watching for updates on early prescription numbers and any additional market access announcements in the coming quarters.
Although Argent Biopharma remains in the early phase of commercialisation, its entry into a key European market and its strong intellectual property position are beginning to shift investor sentiment. If regulatory progress continues and revenue begins to build as anticipated, the stock — currently trading at a modest microcap valuation — may be well placed for a substantial re-rating in the months ahead.
At this stage, Argent Biopharma is one of the few ASX microcaps with a patented, prescription-ready product in-market. For investors with an appetite for early-stage biotech exposure, RGT represents a high-upside opportunity in a sector poised for continued global growth.
