Argent BioPharma Wins German Approval for CannEpil™

Argent BioPharma (ASX: RGT) is proud to announce that CannEpil™, its flagship cannabinoid-based therapy for refractory epilepsy, has been approved for prescription in Germany under a special access scheme. This marks a significant step forward in the company’s European growth strategy and reaffirms its mission to bring innovative treatments to patients suffering from central nervous system (CNS) disorders.

Germany, a leading hub in the European pharmaceutical market, now offers physicians access to CannEpil™ for patients with drug-resistant epilepsy—a patient group in urgent need of new treatment options. The approval not only solidifies Argent BioPharma’s presence in Europe’s largest economy but also opens the door to additional EU markets with similar regulatory frameworks.

“The approval of CannEpil™ in Germany is a meaningful milestone for Argent BioPharma and for patients who have long struggled with limited treatment options,” said Roby Zomer, Managing Director and CEO. “We’re committed to expanding access to cannabinoid-based therapies that make a real difference in the lives of those with chronic and hard-to-treat conditions.”

Why This Matters:

• First Step in EU Expansion: Germany's approval sets the stage for broader access to CannEpil™ across Europe.

• Real Patient Impact: An estimated 816,000 people in Germany live with epilepsy, and many suffer from drug-resistant forms, leaving them with few viable options.

• New Therapeutic Approach: CannEpil™ offers a cannabinoid-based treatment designed to modulate the neuroimmune system, helping to manage seizures where other therapies have failed.

What’s Next:

• Physician Education: Launch of nationwide initiatives to inform and support German healthcare professionals in prescribing CannEpil™.

• Distribution Expansion: Partnering with key German pharmaceutical distributors to increase availability.

• Regulatory Momentum: Continued efforts to gain approval in additional European Union countries.

• Data Collection: Monitoring patient outcomes to support ongoing research and refinement of cannabinoid-based therapies.

Prescription Pathway in Germany:

• CannEpil™ is now available to prescribe by qualified physicians under the country’s special access scheme.

• Patients may be eligible for health insurance coverage, subject to physician recommendations and case-by-case assessments.

This announcement reinforces Argent BioPharma’s leadership in neuroimmune modulation and reflects the increasing global acceptance of cannabinoid-based medicine. Most importantly, it provides real hope for patients who have exhausted conventional treatment options.