This section highlights FDA-related milestones and regulatory updates for drugs developed by Septerna (SEPN).
Over the past two years, Septerna has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SEP-631 and SEP-786. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SEP-631 FDA Regulatory Events
SEP-631 is a drug developed by Septerna for the following indication: For Mast Cell Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SEP-631
- Announced Date:
- March 27, 2025
- Indication:
- For Mast Cell Diseases
Announcement
Septerna, Inc Provides Corporate Overview
AI Summary
Septerna, Inc. provided a corporate overview highlighting its advances in GPCR drug discovery using its Native Complex Platform™. The company is focused on developing next-generation oral small molecule therapies, with plans to select a promising PTH1R agonist candidate for clinical development later this year. Septerna is also preparing to initiate a Phase 1 clinical trial for its SEP-631, a selective MRGPRX2 negative allosteric modulator intended to treat mast cell diseases, in 2025.
In addition to its innovative drug development pipeline, Septerna reported a strong financial position with a cash balance of $420.8 million at the end of 2024, which is expected to sustain its operations into early 2028. The corporate update emphasized the company’s commitment, experienced team, and strategic initiatives in endocrinology, immunology, and metabolic diseases as it continues to advance its multiple GPCR product candidates.
Read Announcement
SEP-786 FDA Regulatory Events
SEP-786 is a drug developed by Septerna for the following indication: PTH1R Agonist.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SEP-786
- Announced Date:
- February 18, 2025
- Indication:
- PTH1R Agonist
Announcement
Septerna, announced its decision to discontinue the Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers.
AI Summary
Septerna, Inc. has decided to stop its Phase 1 clinical trial of SEP-786, an oral small molecule PTH1R agonist being developed for hypoparathyroidism. The decision came after two healthy volunteer participants in the multiple-ascending dose portion experienced unexpected severe (Grade 3) increases in unconjugated bilirubin levels. Although these bilirubin spikes were reversible and not accompanied by related liver enzyme elevations or signs of liver injury, the safety signal prompted an immediate discontinuation of dosing in the affected individuals.
Despite these events, early pharmacological effects such as increased serum calcium and decreased endogenous PTH were observed. Septerna remains committed to advancing its PTH1R program, with plans to select a next-generation candidate from its diverse compound portfolio for accelerated clinical development later this year. Nonclinical studies are currently underway to understand the underlying cause of the bilirubin elevation.
Read Announcement
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