gnyta Shares Add 6% Pre-Bell Europe Drug Regulator Grants Priority Medicines Status to Entrectinib

Ignyta (RXDX) shares were higher 6% in recent pre-market trade after the company said Tuesday that the European Medicines Agency has granted priority medicines (PRIME) designation for entrectinib for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.

Through the PRIME initiative, Ignyta said it will have enhanced EMA support, including optimizing the entrectinib development pathway, potentially accelerating assessment of the marketing authorization application, and engaging in early discussion with EMA and health technology assessments regarding reimbursement pathways.

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