Every 8-K that Septerna, Inc. (SEPN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow SEPN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full SEPN filings page.
Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery, announced the appointment of Rajiv Patni, M.D. as Chief Medical Officer, effective August 24, 2026. The appointment was communicated via an August 25, 2026 press release furnished as an exhibit.
Dr. Patni is a physician-scientist and biopharmaceutical executive with more than 25 years of experience leading research, development, regulatory and medical affairs organizations. He previously held senior roles including Chief Executive Officer of Judo Bio and Chief Research and Development Officer at Reata Pharmaceuticals, as well as Chief Medical Officer positions at several other biopharma companies.
Septerna highlights Dr. Patni’s track record contributing to programs that led to 10 regulatory agency approvals or label expansions across the United States, Europe and additional markets. The company describes itself as advancing a pipeline of novel oral small molecule drug candidates using its proprietary Native Complex Platform® in endocrinology, immunology, inflammation, metabolic diseases and other therapeutic areas.
Septerna, Inc. reported second quarter 2026 results and highlighted progress across its GPCR-focused pipeline. Revenue for the quarter ended June 30, 2026 was $26.7M, largely from its Novo Nordisk collaboration, including $14.6M of upfront payment amortization, $0.9M from research milestones and $11.2M for research services. Research and development expenses rose to $35.1M and general and administrative expenses to $8.5M, leading to a net loss of $13.0M, an improvement from a $24.8M loss a year earlier.
Cash, cash equivalents and marketable securities totaled $516.5M as of June 30, 2026, and the company expects this to fund operations at least into 2029. The Phase 1 trial of SEP-479 for hypoparathyroidism is ongoing; observed elimination half-life of roughly three to four days supports once-daily dosing, with SAD/MAD data expected in the first quarter of 2027. Septerna is also evaluating capital-efficient development paths for SEP-631 in mast cell-driven diseases, advancing its TSHR NAM program toward candidate selection, and continuing discovery work and milestones under its global collaboration with Novo Nordisk.
Septerna, Inc. held its 2026 annual meeting of stockholders on June 26, 2026. Stockholders elected Shalini Sharp, M.B.A. and Jake Simson, Ph.D. as Class II directors to serve three-year terms ending at the 2029 annual meeting and until their successors are elected and qualified or earlier departure.
Sharp received 33,732,317 votes for and 5,808,264 votes withheld, while Simson received 33,716,857 votes for and 5,823,724 votes withheld. Stockholders also ratified Ernst & Young LLP as Septerna’s independent registered public accounting firm for the fiscal year ending December 31, 2026, with 41,207,237 votes for, 4,008 against, and 298,811 abstentions.
Septerna, Inc. reported first quarter 2026 results showing a sharp rise in collaboration revenue and a narrower loss as it advanced multiple clinical programs. Revenue was $26.5 million for the quarter ended March 31, 2026, driven by its Novo Nordisk partnership, compared to $0.2 million a year earlier.
Research and development expenses increased to $29.5 million and general and administrative expenses to $10.3 million, reflecting pipeline growth. Net loss improved to $8.6 million from $21.5 million, and cash, cash equivalents and marketable securities totaled $522.1 million, which the company expects will fund operations at least into 2029. Septerna highlighted positive Phase 1 data for SEP-631 in mast cell-driven diseases and the start of a Phase 1 trial for SEP-479 in hypoparathyroidism, alongside continued work on its TSHR NAM and Novo Nordisk collaboration programs.
Septerna, Inc. has begun a Phase 1 clinical trial of SEP-479, an oral small molecule PTH1R agonist being developed for hypoparathyroidism. The randomized, placebo-controlled study in healthy adults includes single-ascending and multiple-ascending dose cohorts, with enrollment of up to approximately 150 participants in Australia.
The trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics, including effects on endogenous parathyroid hormone and serum calcium, and includes a crossover food-effect study. Septerna anticipates reporting SAD/MAD data in late 2026 or early 2027. SEP-479 aims to offer once-daily oral PTH replacement based on supportive preclinical data.
Septerna, Inc. reported strong fourth quarter and full year 2025 results alongside major pipeline progress. Revenue rose to $24.1 million in the fourth quarter of 2025 and $46.0 million for the full year, up sharply from $0.2 million and $1.1 million in 2024, primarily reflecting collaboration work and amortization of a Novo Nordisk upfront payment.
The company recorded a net loss of $10.7 million for the quarter and $48.9 million for 2025, narrowing from $20.7 million and $71.8 million in 2024, as higher revenue partially offset increased R&D and G&A expenses. Cash, cash equivalents, and marketable securities were $548.7 million as of December 31, 2025, and the cash runway is expected to fund operations at least into 2029.
Clinically, Septerna reported compelling Phase 1 data for SEP-631 in mast cell diseases, supporting Phase 2b development in chronic spontaneous urticaria in the second half of 2026, and is advancing SEP-479 toward a Phase 1 trial in the first half of 2026, while continuing progress on its TSHR NAM and discovery programs.
Septerna, Inc. reported positive Phase 1 results for SEP-631, an oral negative allosteric modulator of MRGPRX2 being developed for mast cell-driven diseases. In healthy volunteers, SEP-631 was well tolerated across single and multiple ascending doses, with an adverse event profile comparable to placebo.
The drug showed dose-proportional pharmacokinetics with an approximate 24-hour half-life, supporting once-daily oral dosing and no meaningful food effect. Using an icatibant-induced skin wheal test, SEP-631 produced robust, dose-dependent suppression of wheal formation, with complete inhibition at doses as low as 10 mg once daily, providing clinical proof-of-mechanism for MRGPRX2 pathway blockade.
Based on these data, Septerna plans to start a randomized, double-blind, placebo-controlled Phase 2b trial of SEP-631 in adults with moderate-to-severe chronic spontaneous urticaria in the second half of 2026, and to follow with an open-label study in chronic inducible urticaria. The company is also evaluating SEP-631 in additional mast cell-driven indications, including atopic dermatitis, interstitial cystitis, migraine and asthma.
Septerna, Inc. filed a Form 8-K to notify investors that the company will be holding meetings with participants at the 44th Annual J.P. Morgan Healthcare Conference during the week of January 12, 2026. The company prepared an investor presentation for these meetings, which is furnished as Exhibit 99.1 and incorporated by reference. This material is being provided as "furnished" information under Item 7.01, meaning it is not treated as filed for liability purposes or automatically incorporated into other Securities Act or Exchange Act filings unless specifically referenced.
Septerna, Inc. filed a current report describing a leadership expansion. On January 8, 2026, the company issued a press release announcing the appointment of industry veteran Mark A. Wilson as Chief Legal Officer. The press release is included as Exhibit 99.1 and is incorporated by reference for additional details.
The disclosure is made under Regulation FD, meaning the company is sharing information intended to keep all investors equally informed. The information in this item and Exhibit 99.1 is furnished rather than filed, so it is not subject to certain liability provisions of the Exchange Act unless specifically incorporated into another filing.
Septerna, Inc. (SEPN) filed an 8-K announcing results and business highlights for the quarter ended September 30, 2025. The company furnished a press release as Exhibit 99.1 detailing the update.
The information under Item 2.02, including Exhibit 99.1, is being furnished, not deemed “filed” under the Exchange Act. Septerna’s common stock trades on the Nasdaq Global Market under the symbol SEPN.
Septerna, Inc. furnished an 8-K disclosing a non-employee director compensation matter. The filing incorporates the company’s Non-Employee Director Compensation Policy by reference from the April 29, 2025 proxy statement and states that Dr. Gottesdiener will receive an additional annual cash retainer of $12,000 for serving as Chair of the R&D Committee, paid quarterly in arrears and prorated for partial quarters. The filing also notes a press release dated September 29, 2025 was furnished and the report is signed by CEO Jeffrey Finer, M.D., Ph.D.
Septerna, Inc. filed a current report to note that it has updated its corporate presentation for use in meetings with investors, analysts and others. The revised presentation, dated September 2025, is furnished as Exhibit 99.1 to this report and is incorporated by reference for informational purposes.
The company states that the materials provided under this item are being furnished rather than filed, meaning they are not subject to certain liability provisions of the Securities Exchange Act and are not automatically incorporated into other SEC filings unless specifically referenced.
Septerna, Inc. furnished an update on its drug development pipeline, reporting that it has begun dosing the first participants in a Phase 1 clinical trial of SEP-631. The press release describes SEP-631 as an oral small molecule MRGPRX2 negative allosteric modulator being studied for the treatment of mast cell-driven diseases, marking an early clinical step for this program. The communication is provided under Regulation FD as furnished information, not filed, and is attached as Exhibit 99.1.
Septerna, Inc. announced that it released its financial results and business highlights for the quarter ended June 30, 2025 and furnished the related press release as Exhibit 99.1 to this Current Report. The filing states the press release is being furnished (and not "filed") for purposes of the Exchange Act, and the 8-K itself does not include detailed financial statements or metrics. Readers should consult Exhibit 99.1 for the substantive results and disclosures.
Septerna held its 2025 Annual Meeting of Stockholders on June 17, 2025 via virtual format. Of the total 44,515,703 eligible voting shares, 34,278,489 shares were represented, establishing a quorum.
Two key proposals were voted on:
- Proposal 1: Election of Class I Directors: - Abraham Bassan, M.S. elected with 29,320,969 votes in favor - Alan Ezekowitz, M.D., D.Phil. elected with 29,195,219 votes in favor
- Proposal 2: Ratification of Ernst & Young LLP as independent auditor was approved with 34,218,829 votes in favor, representing overwhelming support
The company, listed on Nasdaq Global Market under symbol SEPN, is classified as an emerging growth company. Both directors will serve three-year terms until the 2028 annual meeting.