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BLUE Turns Red on Q4 Miss and Delay in Gene Therapy Application
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BLUE Turns Red on Q4 Miss and Delay in Gene Therapy Application

Biotechnology company bluebird bio (NASDAQ:BLUE) has delivered lower-than-expected numbers for the fourth quarter on top-line as well as bottom-line fronts. Shares of the company crashed in morning trading today.

Revenue nosedived 96.3% year-over-year to $62,000, missing expectations by $15.34 million. Net loss per share at $0.38 too missed the cut by $0.05.

Another reason for the stock crash has been a potential delay in its marketing application for lovo-cel. The company had responded to the U.S. FDA earlier this month after it had received “feedback from the FDA on vector and drug product analytical comparability evaluations completed in December 2022.”

BLUE expects a response from the FDA over the next few weeks and is looking at speeding up the submission of its biologics licensing application (BLA) for gene therapy.

However, the company’s CEO was quoted as saying, “We continue to progress our lovo-cel BLA but, speaking plainly, we will likely miss the Q1 2023 submission goal.”

The company is also working on expanding the manufacturing capacity for Zynteglo which is targeted for beta-thalassemia. Additionally, the launch of Skysona remains on track. BLUE had a cash pile of $227 million at the end of 2022 and expects cash burn to hover between $270 million and $300 million for 2023.

 Overall, Wall Street has a consensus price target of $7.33 on BLUE, implying a 69.7% potential upside in the stock. That’s after a nearly 38% correction in the stock so far this year.

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