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bluebird bio (NASDAQ:BLUE) added ~8% pre-market Wednesday after Bank of America upgraded the stock to Buy from Neutral, citing a potential FDA approval for its new gene therapy, lovo-cel, targeted at patients with sickle cell disease (SCD).
The firm expects the company to win timely approval for lovo-cel, which is currently under the FDA’s priority review with a target action date of December 20, 2023.
The analysts compare lovo-cel with exa-cel, another gene therapy for SCD developed by CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (VRTX), noting that the data behind the former is “equal to/more robust” than the latter.
Compared to exa-cel, BofA argues that lovo-cel has undergone studies in more patients with a longer follow-up, and the drug pricing watchdog, the Institute for Clinical Economic Review (ICER), has issued a higher score for the drug on its net clinical benefit.
The team expects bluebird bio (BLUE) to get a head start in a future launch of lovo-cel given its ongoing market rollout of Zynteglo, which the FDA approved as a gene therapy for β-thalassemia last year.
BofA projects $1B peak sales for lovo-cel and raises its price target on BLUE to $10 from $6 per share.
