PMV Pharmaceuticals Earnings Call Transcripts
Fiscal Year 2026
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Rezatapopt demonstrates strong efficacy and safety in heavily pretreated ovarian cancer, with a 46% ORR and 8-month median DOR. NDA submission is planned for Q1 2027, with global expansion and combination studies underway. US market potential is estimated at $350–$420 million.
Fiscal Year 2025
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The company is advancing Rezatapopt, targeting the TP53 Y220C mutation, through a phase II basket study with ovarian cancer as the anchor. Interim data from 50 patients is expected mid-2025, with NDA submission planned for late 2026. Cash reserves support operations through this period.
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The pivotal phase II trial is on track, with interim data for 50 patients expected in July or August, focusing on ovarian and other solid tumors. Regulatory strategy allows for either ovarian-only or tumor-agnostic filing, and cash reserves support operations through 2026.
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Rezatapopt, a first-in-class p53 reactivator, is in a pivotal Phase II trial for TP53 Y220C mutant solid tumors, with interim analysis mid-2024 and NDA submission targeted for end of 2026. The program shows promising efficacy and safety, with global expansion and new pipeline candidates underway.
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Rezatapopt's Phase 2 trial targets multiple solid tumors, with a focus on ovarian cancer and a tumor-agnostic strategy. Interim data will be released mid-2024, supporting an NDA submission by end of 2026. Pipeline expansion and combination studies are ongoing.