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Septerna Advances SEP-631 After Positive Phase 1 Results

Story Highlights
  • Septerna reported strong Phase 1 safety and mechanistic data for SEP-631, supporting once-daily oral dosing.
  • The company will advance SEP-631 into Phase 2b trials in chronic urticaria and assess broader mast cell-driven indications.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Septerna Advances SEP-631 After Positive Phase 1 Results

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The latest announcement is out from Septerna, Inc. ( (SEPN) ).

On March 1, 2026, Septerna reported positive Phase 1 results for SEP-631, an oral negative allosteric modulator of MRGPRX2 being developed for chronic spontaneous urticaria and other mast cell-driven diseases. In healthy volunteers, SEP-631 was well tolerated with an adverse event profile comparable to placebo, showed once-daily pharmacokinetics with a roughly 24-hour half-life and no meaningful food effect, and delivered robust, dose-dependent suppression of icatibant-induced skin wheal formation, providing clinical proof-of-mechanism for MRGPRX2 inhibition.

Based on these findings, Septerna plans to move SEP-631 into a randomized, double-blind, placebo-controlled global Phase 2b trial in adults with moderate-to-severe chronic spontaneous urticaria who remain symptomatic on second-generation antihistamines, and to follow with an open-label study in chronic inducible urticaria with symptomatic dermatographism. The company is also assessing SEP-631’s potential in additional mast cell-driven conditions such as atopic dermatitis, interstitial cystitis, migraine and asthma, positioning the program as a potential differentiated oral option in a range of high-need inflammatory indications.

The most recent analyst rating on (SEPN) stock is a Hold with a $24.00 price target. To see the full list of analyst forecasts on Septerna, Inc. stock, see the SEPN Stock Forecast page.

Spark’s Take on SEPN Stock

According to Spark, TipRanks’ AI Analyst, SEPN is a Neutral.

The score is primarily held back by weak financial performance (large net loss and persistent negative free cash flow) despite rapid revenue growth and a strong equity-heavy balance sheet. Technicals are mixed with near-term softness, while valuation is constrained by negative earnings. Positive corporate events around pipeline progress and leadership additions provide some support.

To see Spark’s full report on SEPN stock, click here.

More about Septerna, Inc.

Septerna, Inc. is a clinical-stage biotechnology company focused on developing oral small-molecule medicines targeting G protein-coupled receptors (GPCRs) for patients with significant unmet medical needs. Using its proprietary Native Complex Platform, the South San Francisco-based company is building a pipeline across endocrinology, immunology and inflammation, metabolic diseases and other therapeutic areas, including mast cell-driven disorders.

Average Trading Volume: 293,328

Technical Sentiment Signal: Buy

Current Market Cap: $1.3B

For detailed information about SEPN stock, go to TipRanks’ Stock Analysis page.

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