• Argent’s cannabinoid-based therapy for refractory epilepsy, CannEpil, has been approved for prescription in Germany
• Epilespy affects around 816,000 people in Germany, with high demand for innovative treatments
• Approval of CannEpil in Germany marks significant milestone expansion in Argent’s European market strategy

Argent BioPharma is up 65% today after its flagship cannabinoid-based therapy for refractory epilepsy CannEpil was approved for prescription in Germany under the special access scheme.

Argent BioPharma (ASX:RGT) said the approval marked a major milestone in the company’s European expansion strategy and reinforced its commitment to providing innovative treatments for central nervous system (CNS) disorders.

Under the special access scheme (SAS), Argent’s proprietary therapy CannEpil is now available for prescription by qualified physicians in Germany.

Patients may be eligible for health insurance coverage depending on their physician’s recommendation and case assessment.

Argent said about 816,000 people in Germany were diagnosed with epilepsy, with a substantial portion suffering from drug-resistant forms.

The company is confident CannEpil offers a promising alternative to traditional treatments,  leveraging cannabinoid-based neuroimmune modulation for seizure management.

Argent said the SAS approval positioned CannEpil as an accessible treatment for refractory epilepsy in Germany, offering  a vital alternative for patients with limited therapeutic options.

Establishing a foothold in Europe and the CNS market

The approval strengthens Argent’s presence in the key pharmaceutical hub of Germany.

Establishing a foothold in the market paves the way for broader penetration into other EU markets with similar regulatory pathways, facilitating wider adoption of its therapies.

Beyond geographical growth, Argent said the German approval underscored the increasing acceptance of cannabinoid-based medicine for CNS disorders.

Strategically, it enhances Argent’s growth trajectory while reinforcing its leadership in neuroimmune modulation and CNS-focused therapeutics.

The company said most importantly, it ensured life-changing treatment access for patients who need it most, aligning with its mission to innovate and expand the reach of cutting-edge medical solutions.

With SAS approval in place, Argent plans to initiate physician education programs across Germany.

It will also expand CannEpil distribution and accessibility through key German partners.

Argent will also continue regulatory efforts to gain approval in additional EU markets, while monitoring market uptake and patient outcomes in Germany to support ongoing R&D.

CEO and managing director Roby Zomer said the German approval of CannEpil represented a significant milestone for Argent BioPharma and patients who rely on innovative treatments for  epilepsy.

“This marks our continued expansion in Europe and reinforces our commitment to improving lives through cutting-edge cannabinoid-based medicine,” Zomer said.