- Timber Pharma ( NYSE: TMBR ) is trading 8.8% higher after it sa id on Wednesday the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) issued a positive opinion on its application for orphan designation for drug, TMB-001, to treat autosomal recessive congenital ichthyosis, a type of rare skin disease.
- Based on Committee for Orphan Medicinal Products decision, the European Commission is expected to issue its decision in about 30 days.
- Medicines that are granted orphan designation by the EU qualify for financial and regulatory incentives including protocol assistance at reduced fees during product development, access to centralized marketing authorization, and 10 years of marketing exclusivity after product approval.
- Congenital ichthyosis is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.
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Timber Pharma rises on positive opinion from EU on orphan designation for rare skin disease treatment