News of Allergy Therapeutics PLC's (AIM:AGY, OTC:AGYTF) marketing authorisation in Germany is "one of the most major catalysts in recent years" for the company, said house broker Cavendish, with the potential to steer the company towards self-sustaining profitability.
German regulators, the Paul Ehrlich Institut, has given the green light for Grass MATA MPL, to be marketed as Grassmuno.
The approval paves the way for the commercial launch of Grassmuno in Europe’s largest allergen immunotherapy market, the broker said, with the grass pollen segment projected to reach around $1 billion by 2030, according to internal company estimates.
The approval also marks the first subcutaneous grass-pollen immunotherapy to be authorised by the German regulators under the Therapieallergene-Verordnung programme.
This provides "first-mover competitive advantage" for Grassmuno in the region.
"While Allergy Therapeutics has faced some challenging headwinds in recent periods, through manufacturing issues and an evolving regulatory landscape, we believe the news today marks a transformational event in the company’s history and should serve as a significant catalyst to the shares.
"Given management’s previous commentary around Grassmuno’s potential to achieve €100m peak sales in Germany alone, we believe that a successful commercial launch, planned for 1Q26, has the potential to steer the company towards self-sustaining profitability."