SYRS - Syros climbs 74% as EMA backs orphan drug designation for lead candidate

• Clinical-stage biotech Syros Pharmaceuticals ( NASDAQ: SYRS ) on Wednesday that the European Medicines Agency (EMA) issued a positive opinion for an orphan drug designation for its lead asset tamibarotene in myelodysplastic syndrome (MDS). The shares of micro-cap biotech surged ~74% in response.
• Developers of drugs with EMA’s orphan designation can receive centralized marketing authorization and claim 10 years of marketing exclusivity in the EU upon product approval.
• In addition, the companies can receive protocol support at reduced fees during the development of orphan drugs and
• Syros ( SYRS ) is advancing tamibarotene for multiple indications including newly diagnosed higher-risk MDS in a Phase 3 trial called SELECT-MDS-1 in combination with azacitidine. Data from the pivotal study is expected in 4Q 2023 or 1Q 2024 with a potential filing of a new drug application in 2024.

For further details see: