Septerna reports Q2 2026 results, sees SEP-479 pharmacokinetics support once-daily dosing

Septerna, Inc. reported second quarter 2026 financial results and pipeline updates on August 10, 2026. The company's Phase 1 trial of SEP-479, an oral PTH1R agonist for hypoparathyroidism, is ongoing, testing safety, tolerability, and pharmacological effects, including calcium and PTH levels, in healthy volunteers through single- and multiple-dose cohorts.¹

Pharmacokinetic data so far show an elimination half-life of roughly three to four days, which the company said points toward a once-daily dosing regimen.¹ To capture full steady-state pharmacokinetics, the multiple-dose portion of the study will run for 14 days.¹ Septerna now expects to report combined single- and multiple-dose data in the first quarter of 2027, and during the quarter it presented preclinical characterization data for SEP-479 at ENDO 2026.¹

For SEP-631, its MRGPRX2 modulator for mast cell-driven conditions, the company previously reported in March 2026 positive Phase 1 results, including tolerability, once-daily pharmacokinetic support, and dose-dependent suppression of induced skin wheal formation.¹ Rather than pursuing a Phase 2b study in chronic spontaneous urticaria, Septerna said it is weighing alternative, more efficient signal-finding study designs in mast cell-driven diseases.¹

The company also continues working toward selecting a development candidate for its TSHR program targeting Graves' disease and thyroid eye disease.¹ Septerna said it continues to hit research milestones under its global collaboration with Novo Nordisk covering oral GPCR-targeted medicines for obesity, type 2 diabetes, and other cardiometabolic conditions.¹

Cash, cash equivalents, and marketable securities stood at $516.5 million as of June 30, 2026, which the company said should fund operations at least into 2029.¹