09:24 AM EDT, 07/08/2024 (MT Newswires) -- Sellas Life Sciences Group ( SLS ) said Monday that the European Commission has granted orphan drug designation to its CDK9 inhibitor SLS009 to treat acute myeloid leukemia.
The designation, which was based on a positive opinion from the European Medicines Agency, qualifies the company for financial and regulatory incentives, including a 10-year period of marketing exclusivity in the European Union after product approval, protocol assistance from the EMA at reduced fees during the product development phase, and access to centralized marketing authorization.
The company expects to share further data about SLS009 in Q3, according to Chief Executive Angelos Stergiou.
Shares of Sellas Life Sciences ( SLS ) were up more than 1% in recent premarket activity.
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