PMVP advances toward NDA filing with Phase 2 data, Orphan designation; cash to Q2 2027
Filed May 12, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 9, 2025 · ~1 min read
Key Changes
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Company plans to file New Drug Application in Q1 2027 for rezatapopt in platinum-resistant ovarian cancer with TP53 Y220C mutation, following interim Phase 2 data announced September 2025.
MD&A: NDA filing timeline verify on EDGAR → -
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FDA granted Orphan Drug Designation in March 2026 for rezatapopt in ovarian, fallopian tube, and primary peritoneal cancers, providing seven years market exclusivity upon approval and potential tax credits.
MD&A: Orphan Drug Designation verify on EDGAR → -
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Cash runway shortened to Q2 2027 (15 months) from prior projection of "at least through end of 2026" (9+ months), with cash declining from $165.8M to $93.5M year-over-year.
MD&A: Cash runway projection verify on EDGAR →
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Generated by AI · Jun 8, 2026 3:20 PM