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Sera Prognostic Shares Spike on Promising Interim Results in Study for Preterm Birth Test

NEW YORK — Shares of Sera Prognostics spiked Wednesday following the company's announcement that the data safety monitoring board (DSMB) overseeing the PRIME study for its PreTRM proteomic test for predicting risk of preterm birth recommended it end study enrollment early due to strong interim results.

Sera's share price more than doubled on Wednesday, closing at $5.49 after closing the previous day at $2.10. In mid-day trading on the Nasdaq, shares hit a high of $9.86. More than 78 million shares of the firm's stock traded during the day, far above the average daily volume of almost 36,000 share-trades. 

Sera said on Wednesday that either of the study's co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis and that as a result the DSMB had recommended the company stop enrollment due to efficacy. The company said it is following this recommendation and will now focus on analyzing and reporting the available data.

Sera's PreTRM test measures and analyzes proteins in the blood that are predictive of preterm birth, enabling physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery.

The PRIME (Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes) study is intended to evaluate whether the PreTRM test mitigates preterm birth risk, improves neonatal outcomes, and reduces overall healthcare cost in the neonatal population. Sera launched the study in 2021 in partnership with health insurer Anthem and its HealthCore subsidiary.

"We are excited by this report of efficacy from the DSMB," Zhenya Lindgardt, president and CEO of Sera, said in a statement. "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. We look forward to sharing top-line results once we have had a chance to analyze the interim look data."