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Septerna (SEPN)

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Earnings summaries and quarterly performance for Septerna.

Research analysts covering Septerna.

Recent press releases and 8-K filings for SEPN.

Septerna Provides Pipeline and Financial Update at J.P. Morgan Healthcare Conference
SEPN
New Projects/Investments
Guidance Update
  • Septerna, focused on G-Protein Coupled Receptors (GPCRs) and its Native Complex Platform, completed its IPO in October 2024 and a deal with Novo last summer, providing a cash runway into at least 2029.
  • The lead program, SCP479 for hypoparathyroidism, is expected to enter Phase 1 trials in the first half of 2026, with top-line results anticipated later in 2026 or early 2027.
  • The second lead program, SCP631 for mast cell diseases, is in a Phase 1 trial, and data is expected to be shared in March 2026.
  • Septerna also has earlier-stage programs, including a TSH receptor negative allosteric modulator for Graves' disease and thyroid eye disease, and an incretin receptor agonist program that is part of a collaboration with Novo Nordisk, where Novo covers all R&D costs.
Jan 13, 2026, 11:45 PM
Septerna Updates on Pipeline and Financial Position at J.P. Morgan Healthcare Conference
SEPN
New Projects/Investments
  • Septerna completed its IPO in October 2024 and a deal with Novo Nordisk in summer 2025, providing a strong cash runway into at least 2029.
  • The company's lead program, SCP479, for hypoparathyroidism, is expected to enter Phase 1 trials in the first half of 2026, with top-line results anticipated late 2026 or early 2027.
  • Phase 1 data for SCP631, targeting mast cell diseases, is expected to be shared in March 2026.
  • Septerna's collaboration with Novo Nordisk, signed in May 2025 and closed in July 2025, covers three specific receptors and two undisclosed targets, with Novo Nordisk covering all R&D costs going forward.
Jan 13, 2026, 11:45 PM
Septerna Provides Update on Pipeline and Financial Position
SEPN
New Projects/Investments
M&A
Guidance Update
  • Septerna is well-capitalized with a cash runway into at least 2029, following its October 2024 IPO and a deal with Novo last summer.
  • The company's lead program, SEP-479 for hypoparathyroidism, is set to enter Phase I trials in the first half of 2026, with top-line results anticipated later in 2026 or early 2027.
  • Another key program, SEP-631 for mast cell diseases, is nearing completion of its Phase I trial, and data will be shared in March 2026.
  • Septerna established a strategic collaboration with Novo Nordisk in May 2025, which includes multiple incretin receptors and undisclosed targets, with Novo covering all R&D costs.
Jan 13, 2026, 11:45 PM
Septerna, Inc. Provides Program Updates and Financial Outlook at J.P. Morgan Healthcare Conference
SEPN
New Projects/Investments
Product Launch
Guidance Update
  • Septerna anticipates initiating a Phase 1 clinical trial for SEP-479 (PTH1R Agonist for hypoparathyroidism) in the first half of 2026, with topline data expected in late 2026 or early 2027.
  • The company expects to present topline Phase 1 SAD/MAD results for SEP-631 (MRGPRX2 NAM for mast cell-driven diseases) at the AAAAI Annual Meeting in March 2026.
  • Septerna has a collaboration with Novo Nordisk for oral small molecules targeting metabolic diseases, which included a $195 million upfront payment received in July 2025 and potential milestones of approximately $500 million per program.
  • The company projects its cash runway will support operating plans at least into 2029.
Jan 12, 2026, 1:30 PM
Septerna Provides Clinical Pipeline Updates and Financial Outlook
SEPN
New Projects/Investments
Guidance Update
  • Septerna, focused on G protein-coupled receptors (GPCRs), provided updates on its portfolio, including SEP-479 for hyperparathyroidism, SEP-631 for mast cell-driven diseases, a TSHR program for Graves' disease, and an incretin receptor agonist program in collaboration with Novo Nordisk.
  • The company's lead candidate, SEP-479, a second-generation PTH1 receptor agonist, is projected to enter the clinic in the first half of next year (2026) after preclinical data showed a projected human half-life of 40-80 hours and an 80% reduction in endogenous PTH levels in a monkey study.
  • SEP-631, an MRGPRX2 negative allosteric modulator, is currently in Phase I, with data from its SAD-MAD study, including an Icatibant challenge, anticipated in the first half of next year (2026).
  • Septerna is well capitalized with cash runway into at least 2029.
Dec 2, 2025, 3:25 PM
Septerna Provides Updates on Clinical Programs and Financial Runway
SEPN
New Projects/Investments
Guidance Update
  • Septerna is well capitalized with a cash runway into at least 2029.
  • The company's second-generation PTH1 receptor agonist, SEP-479, for hyperparathyroidism, is structurally unrelated to a discontinued prior candidate and is projected to have a 40-80 hour human half-life. It is expected to enter the clinic in the first half of next year (2026).
  • The MRGPRX2 negative allosteric modulator, SEP-631, is currently in Phase 1 for mast cell-driven diseases, with data anticipated in the first half of next year (2026).
  • An early-stage TSHR program, a negative allosteric modulator for Graves' disease and thyroid eye disease, has line of sight to a development candidate and could be part of the company's story in 2026.
  • Septerna also has an incretin receptor agonist program, which is part of a collaboration with Novo Nordisk announced in May.
Dec 2, 2025, 3:25 PM
Septerna Provides Update on Key Clinical Programs and Pipeline
SEPN
New Projects/Investments
Guidance Update
  • Septerna is well-capitalized with a cash runway extending into at least 2029.
  • The company's lead candidate, SEP-479, a second-generation PTH1 receptor agonist for hyperparathyroidism, is completing IND-enabling studies and is expected to enter the clinic in the first half of next year (2026).
  • SEP-631, an MRGPRX2 negative allosteric modulator for mast cell-driven diseases, is currently in Phase I with data anticipated in the first half of next year (2026).
  • An earlier-stage program targeting the thyroid-stimulating hormone receptor (TSHR) for Graves' disease and thyroid eye disease is progressing, with a development candidate expected to be part of the company's story in 2026.
Dec 2, 2025, 3:25 PM
Septerna Provides Updates on Clinical Pipeline and Financial Runway
SEPN
New Projects/Investments
Guidance Update
Product Launch
  • Septerna is focused on G protein-coupled receptor (GPCR) drug discovery using its Native Complex Platform.
  • The company's lead compound, SEP631, an MRGPRX2 inhibitor for mast cell-driven diseases, is currently in Phase 1, with readouts expected in the first half of next year (2026). Septerna plans to advance SEP631 into a Chronic Spontaneous Urticaria (CSU) trial after Phase 1.
  • The second compound, SEP479, a PTH1 receptor agonist for hyperparathyroidism, is anticipated to enter Phase 1 in the first half of next year (2026), with data expected in late 2026 or early 2027. This compound is structurally unrelated to a previous candidate that caused bilirubin increases and has shown no such issues.
  • Septerna has a cash runway into at least 2029.
Nov 12, 2025, 9:00 PM
Septerna Updates on Pipeline Progress and Financial Runway
SEPN
New Projects/Investments
Guidance Update
  • Septerna, focused on G protein-coupled receptors (GPCRs), reported an operating cash runway into at least 2029.
  • The company anticipates SEP479 for hyperparathyroidism to enter the clinic in the first half of next year (2026), and Phase 1 data for SEP631 to be shared in the first half of next year (2026).
  • A significant collaboration with Novo Nordisk for an incretin receptor agonist program was announced, including $195 million upfront and coverage of all research and development costs.
  • SEP479, a next-generation candidate, is structurally unrelated to the discontinued SEP786 and shows improved pharmaceutical properties, potentially supporting once-daily dosing.
Nov 10, 2025, 9:00 PM
Septerna, Inc. Reports Q3 2025 Financial Results and Business Highlights
SEPN
Earnings
New Projects/Investments
Board Change
  • Septerna, Inc. reported a net income of $8.2 million for the third quarter ended September 30, 2025, a significant improvement from a net loss of $20.5 million in the prior year period. Revenue for the quarter was $21.5 million, up from $0.2 million in Q3 2024, primarily due to the Novo Nordisk collaboration.
  • As of September 30, 2025, the company held $561.6 million in cash, cash equivalents, and marketable securities, which is projected to fund operations into at least 2029. This cash position includes a $195.0 million upfront payment from Novo Nordisk and a $12.5 million milestone payment from Vertex.
  • The company made significant progress in its pipeline, selecting SEP-479 as a next-generation oral PTH1R agonist development candidate, with a Phase 1 clinical trial anticipated in the first half of 2026. A Phase 1 clinical trial for SEP-631 is also ongoing, with initial data expected in the first half of 2026.
  • Septerna's global collaboration and license agreement with Novo Nordisk formally commenced in July 2025, initiating joint research and development activities for obesity, type 2 diabetes, and other cardiometabolic diseases. Additionally, Keith Gottesdiener, M.D., was appointed to the Board of Directors in September 2025.
Nov 10, 2025, 1:42 PM