SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the appointment of Mark A. Wilson as Chief Legal Officer. Mr. Wilson is an accomplished pharmaceutical and biotech executive with more than 25 years of experience across intellectual property, corporate legal, strategic collaborations and corporate governance matters. “We are thrilled to ...

The most talked about and market moving research calls around Wall Street are now in one place. Here are today's research calls that investors need to know, as compiled by The Fly.Top Upgrades: More bullish on the name, CFRA upgraded Pool Corp. (POOL) to Buy from Hold with a $304 price target.Piper Sandler upgraded SEI Investments (SEIC) to Overweight from Neutral with a price target of $102, up from $93, as part of a Q4 preview for the asset management group. The firm believes SEI will be a "clear benefic ...

SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 3:45 p.m. PT in San Francisco. A live webcast of the presentation will be available in the investors sect ...

SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 3:45 p.m. PT in San Francisco. A live webcast of the presentation will be available in the investors sect ...

Summary of Septerna FY Conference Call Company Overview - **Company**: Septerna (NasdaqGM:SEPN) - **Focus**: G-protein coupled receptors (GPCRs) and drug discovery through the Native Complex Platform - **Financial Position**: Well-capitalized with cash runway into at least 2029 [2][3] Key Programs and Developments SEP-479 - **Indication**: Hyperparathyroidism - **Type**: Second-generation PTH1 receptor agonist - **Clinical Status**: Preparing to enter the clinic in the first half of next year - **Dosing**: Active at 0.15 mg/kg once daily, significantly lower than previous candidate SEP-786 [5][6] - **Pharmacokinetics**: Projected human half-life of 40-80 hours, supporting once-daily oral dosing [6][24] - **Preclinical Data**: Demonstrated normalization of calcium and phosphate levels in a rat model of hyperparathyroidism [5][6] - **Comparison with Peptides**: Aims to achieve similar receptor occupancy to peptide therapies, with effective doses requiring only 2-3% receptor occupancy [25][26] SEP-631 - **Indication**: Mast cell-driven diseases - **Type**: Negative allosteric modulator for MRGPRX2 - **Clinical Status**: Currently in phase I trials with a standard SAD-MAD design - **Preclinical Data**: Demonstrated ability to inhibit extravasation in a mouse model, indicating potential efficacy [10][11] TSHR Program - **Indication**: Graves' disease and thyroid eye disease - **Development Focus**: Optimizing both potency and pharmaceutical properties, aiming for selectivity against closely related receptors [34][35] - **Future Plans**: Targeting Graves' disease first, with potential expansion to prevent thyroid eye disease [36] Market Opportunities - **SEP-479**: Represents a significant market opportunity in treating hyperparathyroidism, with a focus on achieving effective calcium levels in patients [8][31] - **SEP-631**: Addresses unmet needs in mast cell-driven diseases, with a strong preclinical profile [10][11] - **TSHR Program**: Targets a large patient population with Graves' disease, aiming to improve treatment outcomes [36] Additional Insights - **Challenges**: Previous candidate SEP-786 faced issues in phase I due to unconjugated bilirubin increases, leading to its discontinuation [4][5] - **Regulatory Considerations**: Emphasis on ensuring safety in healthy volunteers before advancing to patient studies [32] - **Collaboration**: Notable collaboration with Novo Nordisk on the incretin receptor agonist program [3] Conclusion - Septerna is advancing multiple promising drug candidates with significant market potential, focusing on innovative approaches to GPCR-targeted therapies. The company is well-positioned for future growth with a solid financial foundation and a clear development strategy.

SOUTH SAN FRANCISCO, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2, 2025, at 10:25 a.m. ET in Coral Gables, Florida. A live webcast of the presentation will be available in the investors section of the company’s website at www.sept ...

Group 1 - Septerna, Inc. reported a 3Q25 GAAP EPS of $0.18, indicating a significant improvement from previous losses, primarily driven by partnership-related revenue [1] - The company has a focus on biotechnology, emphasizing innovative approaches in drug development, including novel mechanisms of action and first-in-class therapies [1] - The analysis aims to evaluate the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]

Summary of Septerna Conference Call Company Overview - **Company**: Septerna (NasdaqGM:SEPN) - **Focus**: Drug discovery targeting G protein-coupled receptors (GPCRs) using the Native Complex Platform - **Financial Position**: Cash runway into at least 2029 [4][4][4] Key Programs SEP631 - **Type**: MRGPRX2 inhibitor, currently in Phase 1 clinical trials - **Indication**: Mast cell-driven diseases - **Expected Readouts**: First half of the upcoming year [3][4][5] - **Mechanism**: Targets MRGPRX2, leading to mast cell degranulation through an IgE-independent pathway [5][6] - **Profile**: - High potency (single-digit nanomolar to high picomolar) - Excellent oral bioavailability with once-daily dosing projected - Good preclinical safety profile [6][6][11] - **Phase 1 Trial Design**: Randomized placebo-controlled, includes skin challenge with Icatibant [8][9][17] SEP479 - **Type**: PTH1 receptor agonist for hypoparathyroidism, expected to enter the clinic in the first half of next year [3][28] - **Challenges**: Historically difficult target for small molecules; previous candidate (SEP786) faced issues with bilirubin increases [29][30] - **Current Status**: - New compound shows no UGT1A1 inhibition or bilirubin increase - Predicted human half-life of 40-80 hours, aiming for once-daily oral dosing [30][31] - **Clinical Goals**: - Aim for serum calcium increases of about 1 mg/dL in Phase 1 trials - Final IND enabling studies wrapping up, including a 28-day GLP-tox study in monkeys [33][34][40] Future Directions - **Phase 2 Strategy**: Plans to move into chronic spontaneous urticaria (CSU) trials post-Phase 1 [22][26] - **Exploration of Other Indications**: Potential for expansion into asthma and pain-related conditions involving mast cells [26][26] - **Collaboration with Novo**: Developing a TSH receptor negative allosteric modulator, with hopes for a development candidate next year [41][42] Additional Insights - **Safety Profile**: SEP631 has shown no liver involvement in preclinical studies, distinguishing it from other X2 agonists [11][12] - **Market Opportunities**: Significant market potential for both SEP631 and SEP479 due to their targeted mechanisms and the unmet medical needs in their respective indications [4][4][28]

Summary of Septerna's Conference Call Company Overview - **Company**: Septerna - **Focus**: G protein-coupled receptors (GPCRs) and small molecule discovery using the Native Complex platform - **Financial Position**: Well-capitalized with an operating cash runway into at least 2029 [2][2][2] Key Programs 1. **SEP479 Program** - **Target**: Parathyroid hormone receptor agonist for hyperparathyroidism - **Clinical Development**: Anticipated entry into the clinic in the first half of next year [3][3][9] - **Pharmacodynamics**: Demonstrated ability to normalize serum calcium and phosphate levels in preclinical studies with low dosing (0.15 mg/kg) [7][7][8] - **Safety Profile**: Improved pharmaceutical properties compared to previous candidate SEP786, which was discontinued due to safety issues related to bilirubin levels [6][14][15] - **Half-Life**: Predicted human half-life of 40-80 hours, supporting once-daily dosing [7][17][17] 2. **SEP631 Program** - **Target**: MRGPRX2 negative allosteric modulator for mast cell-driven diseases, including chronic spontaneous urticaria - **Clinical Development**: Currently in phase one trial, with data expected in early 2026 [9][12][25] - **Pharmacodynamics**: Demonstrated complete inhibition of extravasation in preclinical models [11][11] - **Differentiation**: Unique profile as an insurmountable negative allosteric modulator, potentially offering a long duration of action [10][19] 3. **Thyroid-Stimulating Hormone Receptor Program** - **Target**: Graves' disease and thyroid eye disease - **Market Opportunity**: Significant unmet need with a large market size; current treatments are outdated [26][26][27] - **Mechanism**: Utilizing an insurmountable negative allosteric modulator approach to inhibit receptor activation by various antibodies [27][28] Collaborations and Financials - **Collaboration with Novo Nordisk**: Announced a significant collaboration in May, including $195 million upfront and full support for R&D costs [4][4] Market Context and Competitive Landscape - **Mast Cell Indications**: Potential to target multiple mast cell-driven diseases, with chronic spontaneous urticaria as the initial focus [21][21] - **Competitive Landscape**: Acknowledgment of a crowded market for chronic spontaneous urticaria treatments, with a focus on differentiating SEP631 from existing therapies [22][22][19] Future Outlook - **Pipeline Expansion**: The platform has broader applications for GPCRs, with potential for a deep pipeline of products targeting various therapeutic areas [29][30] - **Clinical Trials**: Plans to initiate trials for SEP631 in chronic spontaneous urticaria following successful phase one results [25][25] Conclusion - **Overall Sentiment**: Positive outlook on the progress of Septerna's programs, with a focus on advancing clinical development and addressing significant market needs in the biopharma space [30][30]

Core Insights - Septerna, Inc. reported a quarterly loss of $0.09 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.19, marking an earnings surprise of -147.37% [1] - The company's revenues for the quarter ended September 2025 were $21.5 million, missing the Zacks Consensus Estimate by 71.34%, compared to revenues of $0.18 million a year ago [2] - The stock has underperformed, losing about 19.2% since the beginning of the year, while the S&P 500 gained 14.4% [3] Financial Performance - Over the last four quarters, Septerna has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is $0.26 on revenues of $46.5 million, and for the current fiscal year, it is -$1.00 on revenues of $140.34 million [7] Industry Context - Septerna operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 36% of over 250 Zacks industries [8] - The industry has shown a strong correlation between near-term stock movements and trends in earnings estimate revisions, indicating that the performance of Septerna may be influenced by broader industry trends [5][8] Future Outlook - The company's earnings outlook will be crucial for assessing future stock performance, particularly in light of management's commentary during the earnings call [4] - The estimate revisions trend for Septerna was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market [6]