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The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states
Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…
Shots:
Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab
As per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…
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The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states
The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

