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Johnson & Johnson, Tesaro Niraparib Trial Enrollment Suspension Not Related To Safety

Johnson & Johnson, Tesaro Niraparib Trial Enrollment Suspension Not Related To Safety

TESARO Inc (NASDAQ: TSRO) fell as much as 9.8 percent Friday on news that Johnson & Johnson (NYSE: JNJ) suspended the enrollment of their shared phase 2 niraparib trial for prostate cancer.

A Johnson & Johnson spokesperson told Benzinga the temporary hold isn't related to safety, and the firm anticipates re-opening enrollment shortly.

“The study enrolled very rapidly,” representative Kellie Mclaughlin told Benzinga. “Our team put a temporarily hold on enrollment so we could assess the enrolled currently patients against the protocol criteria. We need to make sure we don’t over-enroll some patient types and under-enroll others.”

See Also: Notes From ASCO 2017: Tesaro, Amgen, Others Report New Data

Important Date Nears

Niraparib is coming up on its Prescription Drug User Fee Act date of June 30 and already received approval from the U.S. Food and Drug Administration for treatment of ovarian cancer. Tesaro is also researching indications of lung and breast cancers.

At time of publication, Tesaro shares recovered to trade 0.3 percent above Friday’s open at a rate of $140.05.

Johnson & Johnson shares had initially spiked on the trial news, but waned to trade up 0.4 percent at $131.12.

Posted-In: Kellie Mclaughlin Niraparib PDUFANews Health Care Top Stories Exclusives General Best of Benzinga


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