Septerna
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 68
- Market Cap
- -
- Introduction
Septerna, Inc. is a clinical-stage biotechnology company, which engages in pioneering a new era of G protein-coupled receptor oral small molecule drug discovery powered by proprietary Native Complex PlatformTM. Its pipeline of product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. The company was founded by Robert Joseph Lefkowitz, Arthur Christopoulos, Patrick Sexton, and Jeffrey T. Finer in December 2019 and is headquartered in South San Francisco, CA.
Novo Nordisk and Septerna Partner on $2.2 Billion Deal to Develop Oral Obesity Treatments
• Novo Nordisk and Septerna have formed a $2.2 billion collaboration to develop oral small molecule therapies targeting GLP-1, GIP, and glucagon receptors for obesity and cardiometabolic diseases.
• The partnership combines Novo Nordisk's expertise in metabolic diseases with Septerna's proprietary Native Complex Platform™ technology for G protein-coupled receptor (GPCR) drug discovery, addressing a significant untapped opportunity in GPCR therapeutics.
• Septerna will receive over $200 million in upfront and near-term payments, with both companies jointly conducting research through candidate selection before Novo Nordisk assumes global development responsibilities.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
ArkBio's AK3280 Shows Promising Results in Phase II IPF Trial with Significant Lung Function Improvement
• ArkBio's novel anti-fibrotic drug AK3280 demonstrated significant improvement in lung function during Phase II trials for idiopathic pulmonary fibrosis, with the highest dose group showing a 209.4 mL increase in FVC.
• Unlike current IPF treatments that merely slow disease progression, AK3280 achieved actual improvement in respiratory function while maintaining a favorable safety profile without the gastrointestinal issues associated with existing therapies.
• The multicenter, randomized study conducted across 31 clinical sites in China positions AK3280 as a potential breakthrough for IPF patients, with preparations now underway for pivotal Phase III clinical trials.
Novo Nordisk Invests $2 Billion in Chinese "Triple G" Weight Loss Treatment
• Novo Nordisk has committed $2 billion to develop a novel "triple G" weight loss injection in China, expanding its portfolio beyond its successful GLP-1 medications Ozempic and Wegovy.
• The investment follows Novo Nordisk's recent $2.2 billion collaboration with Septerna to develop oral obesity therapies, highlighting the company's aggressive expansion in the global obesity treatment market.
• This strategic move into the Chinese market addresses the growing obesity epidemic in Asia, where approximately 5% of China's 1.4 billion population is classified as obese, representing a significant untapped market opportunity.
Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients
• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage.
• The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022.
• Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.
Septerna Halts Phase 1 Trial of SEP-786 for Hypoparathyroidism Due to Safety Concerns
• Septerna discontinues Phase 1 trial of SEP-786, an oral PTH1R agonist for hypoparathyroidism, following two cases of severe elevated unconjugated bilirubin in multiple-ascending dose study.
• Despite early signs of target engagement with increased serum calcium and decreased PTH levels, the company pivots to advancing alternative PTH1R agonist candidates with distinct chemical structures.
• Company maintains strong financial position with $440.1 million in resources, supporting operations through 2027 while advancing multiple programs including SEP-631 for mast cell diseases.
TEPEZZA Sales Surge as Thyroid Eye Disease Treatment Market Expands to $2.3 Billion
• TEPEZZA, the first FDA-approved treatment for thyroid eye disease, generated $1.9 billion in sales for 2024, with $460 million in Q4 alone, addressing a critical unmet need for patients with limited treatment alternatives.
• The global thyroid eye disease market reached $2.3 billion in 2023 across seven major markets, with continued growth expected through 2034 due to increasing disease awareness and rising prevalence.
• Several competitors are developing alternative therapies, including Immunovant's batoclimab and Sling Therapeutics' oral small molecule linsitinib, potentially reshaping the treatment landscape in the coming years.
Sionna Therapeutics Launches $191M IPO to Challenge Vertex in Cystic Fibrosis
• Sionna Therapeutics has launched a $191 million IPO to fund its cystic fibrosis drug development program, aiming to compete with Vertex Pharmaceuticals.
• Sionna's approach focuses on stabilizing a difficult-to-drug region of the CFTR protein, potentially restoring function more effectively than existing therapies.
• The company plans to advance a two-drug combination into late-stage testing and evaluate one of its stabilizers alongside Vertex's Trikafta.
• Sionna has secured substantial venture funding and is among several biotechs pursuing IPOs, despite recent market challenges for newly public companies.
Pharma Stock Roundup: Novo Nordisk's Obesity Study Disappoints, Lilly's Zepbound Approved for Sleep Apnea
• Novo Nordisk's CagriSema obesity treatment showed a 22.7% weight loss in Phase III, falling short of the anticipated 25% reduction, impacting stock prices.
• Eli Lilly's Zepbound (tirzepatide) received FDA approval for moderate-to-severe obstructive sleep apnea (OSA), marking it as the first drug for obesity-related OSA.
• AstraZeneca and Daiichi Sankyo withdrew their EU application for Dato-DXd in non-small cell lung cancer (NSCLC) but pursue U.S. approval for EGFR-mutated NSCLC.
• Pfizer's Braftovi gained FDA approval in combination with Erbitux and mFOLFOX6 for first-line treatment of metastatic colorectal cancer with BRAF mutations.
Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial
• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial.
• The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users.
• Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy.
• The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.
Celldex Therapeutics Initiates Phase 2 Trial of Barzolvolimab for Atopic Dermatitis
• Celldex Therapeutics has begun a Phase 2 clinical trial to evaluate barzolvolimab for treating moderate to severe atopic dermatitis, a chronic inflammatory skin condition.
• Barzolvolimab, a humanized monoclonal antibody, targets mast cells implicated in atopic dermatitis, potentially offering a novel therapeutic approach.
• The randomized, double-blind, placebo-controlled study will assess the efficacy and safety of barzolvolimab, with primary endpoint focused on pruritus reduction.
• Positive clinical data from ongoing trials could position Celldex favorably in the dermatology market, addressing unmet needs in atopic dermatitis treatment.
Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials
• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML).
• The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML.
• Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML.
• FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.
Sangamo Therapeutics' Fabry Disease Candidate ST-920 Gains Accelerated Approval Pathway
• Sangamo Therapeutics' shares surged after the FDA agreed to a regulatory pathway for accelerated approval of isaralgagene civaparvovec (ST-920) for Fabry disease.
• The FDA will consider data from the Phase I/II STAAR trial, using the rate of decline in eGFR at 52 weeks as the primary basis for approval.
• Sangamo plans to submit a BLA in the second half of 2025, three years ahead of previous estimates, potentially bringing the treatment to patients sooner.
• Septerna, focusing on GPCR therapies, raised $288 million in an upsized IPO, highlighting renewed interest in biotech IPOs.
Septerna Raises $288M in Upsized IPO to Advance Novel GPCR-Targeting Drug Pipeline
• Septerna successfully completed an upsized IPO raising $288 million, selling 16 million shares at $18 each, demonstrating strong investor confidence in clinical-stage biotech companies.
• The company's lead drug candidate SEP-786, targeting hypoparathyroidism, recently entered Phase 1 clinical trials with data expected by mid-2025.
• Septerna plans to allocate $117 million of the proceeds to advance SEP-786 and $37 million for developing SEP-631 for chronic spontaneous urticaria and mast cell conditions.
Septerna Initiates Phase 1 Trial of Oral PTH1R Agonist SEP-786 for Hypoparathyroidism
• Septerna has commenced a Phase 1 clinical trial for SEP-786, a novel oral small molecule agonist targeting the parathyroid hormone 1 receptor (PTH1R).
• The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SEP-786 in healthy adult volunteers.
• SEP-786 is being developed as a potential disease-modifying treatment for hypoparathyroidism, offering convenient, full-day calcium control.
• The Phase 1 trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) segments, enrolling up to 180 participants.
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