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Pharma & Biotech

Septerna halts Phase 1 hypoparathyroidism trial, shares plummet

Septerna shares tumbled more than 60% after the clinical-stage biotechnology firm announced it is halting its Phase 1 clinical trial of SEP-786 targeting hypoparathyroidism.

The company said it chose to discontinue the trial due to the occurrence of elevated bilirubin levels in trial participants.

On a positive note, early pharmacological activity signals were observed, indicating potential therapeutic benefits.

“We observed early signals of on-target pharmacological activity with SEP-786, with increases in serum calcium and corresponding decreases in endogenous PTH, reinforcing our commitment to developing an oral small molecule PTH1R agonist for hypoparathyroidism,” Septerna CEO Dr Jeffrey Finer said in a statement.

Septerna plans to pivot towards developing next-generation PTH1R agonists with different chemical structures and aims to select a new candidate for clinical trials later in 2025.

“We have multiple attractive PTH1R agonists from which we plan to select a next-generation candidate to accelerate toward the clinic later this year to quickly regain momentum with our PTH1R program,” Finer said.

Septerna shares traded down 63.7% at $4.70 in the early afternoon on Tuesday.

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