Sera Prognostics Inc SERA announced that the Data Safety Monitoring Board (DSMB) overseeing its pivotal PRIME study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis.
The company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data.
Sera offers the PreTRM Test, a blood-based biomarker test that provides an early, accurate, and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies.
"It is unexpected for trials to stop early for efficacy since most statistical power is typically reserved for the final analysis, which makes this event that much more encouraging," said Zhenya Lindgardt, President and CEO of Sera Prognostics.
Sera Prognostics stock is gaining on heavy volume, with a session volume of 30.85 million shares traded, compared to the trailing 100-day volume of 36.12k shares, according to data from Benzinga Pro.
Price Action: SERA shares are up 234.80% at $7.03 on the last check Wednesday.
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