Oryzon Genomics Earnings Call Transcripts
Fiscal Year 2026
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Interim ALICE-2 results showed high response rates and similar tolerability at both doses. A two-cohort Phase III plan is being prepared for FDA discussion, with enrollment targeted by year-end and CR data sought by end-2029.
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Strong clinical data for iadademstat in AML show 100% response rates and favorable safety, supporting plans for accelerated approval in high-risk subgroups. Market analysis projects over $1 billion US peak sales, with a diversified pipeline and CNS assets targeting large unmet needs.
Fiscal Year 2025
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Key opinion leaders highlighted the urgent need for effective BPD treatments, with Vafidemstat showing rapid, significant improvements in agitation and aggression and a favorable tolerability profile. The drug’s novel mechanism and real-world trial design support its potential for approval and broader psychiatric application.