Immuncor shares sink on FDA action (BLUD)
Immunocor Inc. (Nasdaq: BLUD) shares are down about 27% near $11.83 at the market’s open, after the company said the FDA plans to revoke the company’s biologics license with respect to its Reagent Red Blood Cells and Anti-E Blood Grouping Reagent product.
The company has 10 working days to respond to the FDA’s administrative action and 30 days to submit a remediation plan.
The FDA has not ordered the recall of any of the Immunocor’s products.
“We have been working diligently to improve our quality systems and processes… we are committed to completing this Project as quickly as possible,” the company said in a statement.
Immunocor in a statement says it continues to work on quality process improvements, and expects to spend between $4 million and 4.5 million on them this fiscal year. — Mike Tarsala
