Status note Next-generation GnRH antagonist; composition-of-matter patents expire 2039. APC: planned Phase 2b dose-optimization study (substantial modification application submitted via EU CTIS Jun 8, 2026). AUR: optimized Phase 2 design submitted to FDA Apr 6, 2026; FDA written feedback and central IRB approval (with modifications) received Jul 16, 2026. Endometriosis: PRECISION-E2 Phase 2a genomics-enabled trial in UAE; IND authorized by UAE DOH Jul 31, 2026.
Status note IND #139837 (CDER Oncology Division). Phase 2 SKNJCT-003 in nBCC: positive dose response from pre-specified expanded dataset analysis announced May 6, 2026. SKNJCT-005 registrational Phase 2b for Gorlin Syndrome: protocol submitted to FDA Jun 3, 2026; FDA safety review complete and 'Study May Proceed' letter issued Jul 27, 2026 authorizing initiation of NDA-enabling registrational Phase 2b.
Per-asset detail extracted from the 10-Q filed 2026-08-12. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
No lead program on file for this company.
No active ClinicalTrials.gov trials matched to this company as sponsor or collaborator.
No specialist-fund holders in 13F data for this company.
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