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SOUTH SAN FRANCISCO - Septerna, Inc. (NASDAQ:SEPN), a clinical-stage biotechnology company with a market capitalization of $494 million, has dosed the first participants in a Phase 1 clinical trial of SEP-631, an oral treatment being developed for chronic spontaneous urticaria and other mast cell-driven diseases, the company announced Thursday. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn.
The trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SEP-631 in healthy adult volunteers. The randomized, placebo-controlled study is expected to enroll approximately 150 participants and includes both single-ascending dose and multiple-ascending dose components. The stock has shown remarkable momentum, posting a 91% gain over the past six months, with analysts maintaining a bullish stance - three have recently revised their earnings estimates upward.
SEP-631 is a selective oral small molecule that acts as a negative allosteric modulator of Mas-related G protein-coupled receptor X2 (MRGPRX2), which plays a role in mast cell activation and degranulation.
"Mast cell-driven diseases represent significant unmet medical needs worldwide, affecting millions of patients who often struggle with inadequate symptom relief with current therapies," said Jae Kim, chief medical officer of Septerna, in the press release.
Chronic spontaneous urticaria is a systemic inflammatory skin disease characterized by recurring itchy, painful hives and angioedema. Many patients do not respond adequately to antihistamines, the current first-line treatment.
The trial will include an icatibant skin challenge to assess pharmacodynamics in the multiple-ascending dose portion of the study.
In preclinical studies, SEP-631 demonstrated inhibition of MRGPRX2 and blocked mediator-induced skin extravasation in mice engineered to express the human MRGPRX2 receptor, according to the company’s statement.
Septerna is a clinical-stage biotechnology company focused on G protein-coupled receptor therapies using its Native Complex Platform technology. With a current ratio of 22.09, the company maintains strong liquidity to fund its operations. InvestingPro subscribers can access 8 additional key insights about Septerna’s financial health and growth prospects, along with detailed analyst forecasts and valuation metrics.
In other recent news, Septerna, Inc. reported its financial results for the second quarter, highlighting a widened net loss despite surpassing earnings expectations. The biotechnology company posted an adjusted earnings per share (EPS) loss of $0.56, which was $0.07 better than the analyst estimates of a $0.63 loss. Revenue for the quarter was reported at $100,000. However, the company’s net loss increased to $24.8 million from $16.4 million in the same period last year. This increase was attributed to higher research and development expenses, which rose to $22.2 million from $15.0 million year-over-year. These financial results are part of the recent developments surrounding Septerna.
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