Clinical TrialMay 11, 2026, 04:03 PM
Septerna's SEP-631 Phase 1 Data Positive; SEP-479 Trial Initiated
AI Summary
Septerna, Inc. announced positive Phase 1 clinical results for SEP-631, an MRGPRX2 NAM, supporting its advancement into Phase 2b development for chronic spontaneous urticaria (CSU) in the second half of 2026. The company also initiated a Phase 1 clinical trial for SEP-479, an oral small molecule PTH1R agonist for hypoparathyroidism. Septerna reported a strong financial position with $522.1 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2029. Revenue for Q1 2026 significantly increased to $26.5 million, and net loss decreased to $8.6 million.
Key Highlights
- SEP-631 Phase 1 data supports Phase 2b development in Chronic Spontaneous Urticaria (CSU) in H2 2026.
- Phase 1 clinical trial initiated for SEP-479, an oral small molecule PTH1R agonist for hypoparathyroidism.
- Cash, cash equivalents, and marketable securities totaled $522.1 million as of March 31, 2026.
- Cash position expected to fund operations at least into 2029.
- Revenue from Novo Nordisk collaboration was $26.5 million for Q1 2026, up from $0.2 million in Q1 2025.
- Net loss for Q1 2026 was $8.6 million, significantly reduced from $21.5 million in Q1 2025.
- Research and development expenses increased to $29.5 million in Q1 2026 from $19.3 million in Q1 2025.
- Chief Medical Officer Jae Kim, M.D., will depart and serve in an advisory capacity during transition.