Septerna discontinues SEP-786 Phase 1 trial after bilirubin events; plans next-gen PTH1R agonist

Septerna, Inc.

Discontinued SEP-786 Phase 1 trial due to two Grade 3 unconjugated bilirubin events without ALT/AST elevation; no SAEs or liver injury.
Multiple next-generation oral PTH1R agonists in portfolio; candidate selection and clinic entry expected later in 2025.
Cash, cash equivalents, and marketable securities $137.5M as of Sep 30, 2024; plus $302.6M from Oct IPO; runway into H2 2027.
Also advancing SEP-631 (MRGPRX2 negative allosteric modulator) for mast cell diseases; clinical initiation planned later in 2025.

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