**Summary**
Allergy Therapeutics plc has received marketing authorisation from Germanys Paul Ehrlich Institut (PEI) for **Grassmuno®**, a subcutaneous grass pollen allergen immunotherapy. This approval marks the first subcutaneous grass-pollen immunotherapy under Germanys TAV programme, with commercialisation expected in Q1 2026. Grassmuno is designed to treat moderate to severe allergic symptoms (e.g., rhinitis, rhinoconjunctivitis) caused by grass pollen in adults, offering a short-course, pre-seasonal treatment. The approval follows a comprehensive submission of quality, safety, and clinical efficacy data, including results from the pivotal Phase III G306 trial, which demonstrated significant symptom reduction compared to placebo.
Grassmuno’s unique formulation includes a novel adjuvant system (MPL® and MCT) to enhance immunogenicity. The product targets the growing German seasonal allergy market, projected to reach ~US$1 billion by 2030. Allergy Therapeutics views this approval as a milestone, validating its MATA MPL platform and supporting its expansion strategy into other global markets and allergens (e.g., birch, ragweed). The company is also advancing a Phase III trial (G308) in paediatric patients to further broaden Grassmuno’s application.
This regulatory success underscores Allergy Therapeutics’ commitment to innovative, aluminium-free immunotherapies and positions Grassmuno as a key driver of its business in Germany, its largest market.