FDA Mishaps Have Investors Asking “What’s Going On With bluebird bio?”

Gene-focused biotech bluebird bio (NASDAQ: BLUE) continues to experience prolonged difficulties in moving its flagship LentiGlobin immunotherapy for beta-thalassemia (a blood disorder that leads to lack of oxygen) to market in the U.S., leading many to question the company's fluency in regulatory operations. Meanwhile, clinical trial delays caused by the pandemic have thrown bluebird's drug development timetables off by many months.

And with bluebird's recent announcement that it is seeking to issue $400 million in new stock, it's clear that the company may be at risk of looming cash flow issues. When these facts are taken in the context of the 2019 legal issues the company faced pertaining to its alleged anti-competitive practices, bluebird is a heavily battered business.

Investors should be increasingly concerned about the company's value in the short term, as well as its long-term competency at navigating regulatory hurdles. How did the former rising star of the gene therapy market end up in such a precarious position? 

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Source Fool.com