Bluebird Beats Investor Lawsuit Over FDA Black Box Warning (1)

Bluebird Bio Inc. defeated allegations it misled investors over the terms regulators would apply for approving its sickle cell disease treatment and odds of getting a coveted voucher, a federal judge ruled.

The investor’s amended complaint didn’t plausibly allege a strong inference of intent or recklessness to defraud investors about Bluebird’s ability to earn a voucher to expedite the Food and Drug Administration review process for specific therapies, Judge Patti B. Saris said in her May 23 order. The lead plaintiff’s theory rested on “fraud by hindsight,” and an agreement concurred to by another biotechnology company to buy Bluebird’s ...