Cerus (CERS +13.2%) is up on more than double normal volume in response to its announcement that the previously announced shortage of Fresenius Kabi platelet additive solution (PAS) will be less disruptive than anticipated.
The key development was the FDA's agreement to review Fresenius' regulatory submission under special guidelines (CBE-30) that allow the distribution of the product during the review period. The CBE-30 (Changes Being Effected in 30 Days) was necessary to address changes in raw materials used by the manufacturer of the PAS container.
The PAS is a key component for Cerus customers who produce INTERCEPT platelets on a particular apheresis platform.
Previously: Cerus lowers revenue guidance due to PAS shortage; shares down 5% premarket (May 23)
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