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SOUTH SAN FRANCISCO - Septerna, Inc. (Nasdaq: SEPN), a biotechnology firm focused on GPCR drug discovery with a market capitalization of $575 million, announced today the discontinuation of its Phase 1 clinical trial for SEP-786, a treatment under investigation for hypoparathyroidism. The news comes as the stock has experienced significant volatility, falling nearly 40% over the past six months, though showing recent signs of recovery with a 14% gain in the past week. The decision was made following the occurrence of severe elevated unconjugated bilirubin levels in two healthy volunteers participating in the trial, despite no liver injury or serious adverse events being reported.
SEP-786 is an orally administered small molecule agonist of the parathyroid hormone 1 receptor (PTH1R). The adverse events, classified as Grade 3, were observed in the multiple-ascending dose (MAD) portion of the trial, leading to the discontinuation of dosing for the affected participants. The observed bilirubin elevations were reversible, and there were no instances of liver injury, cholestasis, or hemolysis across all trial participants.
Jeffrey Finer, M.D., Ph.D., CEO and co-founder of Septerna, stated that early indications of SEP-786’s pharmacological activity were promising, as evidenced by increases in serum calcium and corresponding decreases in endogenous PTH. Despite the trial’s halt, Septerna remains committed to developing an oral small molecule PTH1R agonist for hypoparathyroidism and plans to select a next-generation candidate from its portfolio of PTH1R agonists to progress towards clinical trials later this year.
Non-clinical studies have been initiated to investigate the mechanism behind the bilirubin elevation, an off-target effect that was not predicted in preclinical toxicology studies. Septerna’s Chief Medical (TASE:PMCN) Officer, Jae B. Kim, M.D., emphasized the unexpected nature of the bilirubin elevation risk.
In addition to SEP-786, Septerna is progressing with SEP-631, a selective oral small molecule MRGPRX2 negative allosteric modulator targeting mast cell diseases, with clinical trials expected to commence later this year.
According to InvestingPro analysis, the company maintains a strong financial position with a current ratio of 10.08, indicating excellent liquidity. The company’s cash position appears robust, with cash, cash equivalents, and marketable securities totaling $137.5 million as of September 30, 2024, and an additional $302.6 million in net proceeds from its IPO in October 2024. With analysts setting price targets ranging from $38 to $50, and the company’s next earnings report scheduled for February 26, investors seeking detailed financial insights can access additional ProTips and metrics through InvestingPro. These funds are anticipated to support Septerna’s operations into at least the second half of 2027.
This article is based on a press release statement from Septerna, Inc. and contains no endorsements or speculative information.
In other recent news, Septerna Inc has been the focus of several analyst reports. Cantor Fitzgerald maintained an Overweight rating on Septerna’s stock, with a price target of $50. They anticipate peak sales for Septerna’s lead product, SEP-786, to reach $820 million globally, with an additional $250 million attributed to the company’s platform value. TD Cowen also initiated coverage on Septerna with a Buy rating, citing confidence fueled by preclinical data from SEP-786. JPMorgan echoed this positive outlook, assigning an Overweight rating and setting a price target of $38.
Further, Septerna has made strategic moves in its leadership, appointing Gil Labrucherie as its new Chief Financial Officer. Labrucherie’s experience in senior finance and legal roles within the biopharmaceutical sector is expected to enhance Septerna’s financial and capital strategy.
These developments come as Septerna continues to innovate in the G protein-coupled receptor (GPCR) drug discovery field, with a focus on developing oral small molecule treatments in endocrinology, immunology, inflammation, and metabolic diseases.
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