Pieris slammed with FDA hold; Biogen adds PhIV for Spinraza
→ Boston-based Pieris $PIRS has been forced to hit the brakes on a slate of Phase I studies for its 4-1BB/HER2 fusion protein drug PRS-343 after the FDA hit the company with a partial hold. The biotech can continue to dose patients already in the studies, but can’t add patients until after it conducts “an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings.” The biotech says no adverse events were cited and still plans to launch their Phase II program for the drug later this year — provided the FDA can be satisfied. “We also remain on track to present comprehensive data from both the monotherapy and atezolizumab combination phase 1 studies at a medical conference later this year,” says CEO Stephen Yoder. Their stock was down about 6% in morning trading Tuesday.
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