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Fresenius Investigates Akorn FDA Compliance, Says Outcome May Affect Merger

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Fresenius Investigates Akorn FDA Compliance, Says Outcome May Affect Merger
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What Happened

Akorn, Inc. (NASDAQ: AKRX) shares fell more than 30 percent Monday evening after Fresenius Kabi AG announced an independent investigation into alleged breaches of FDA data integrity requirements related to product development.

Akorn later released a statement confirming its active participation in the probe.

Why It’s Important

The outcome of the investigation may derail a deal between the companies that saw Fresenius buying Akorn for $34 per share. The acquisition was announced in April 2017 and has yet to close.

Akorn assured investors that the transaction should continue as planned.

“To date, the Company's investigation has not found any facts that would result in a material impact on Akorn's operations and the Company does not believe this investigation should affect the closing of the transaction with Fresenius,” the statement read.

What’s Next

Fresenius noted that it will not provide updates throughout the investigation, but it will continue to seek regulatory clearance for the merger from the Federal Trade Commission.

At time of publication, Akorn shares had marginally recovered and were set to open down 28.7 percent around $21.60.

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