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Shares of bluebird bio, Inc. (NASDAQ:BLUE) are peeking above $6, up as much as 80% in heavy trading on Monday morning, after the FDA AdCom voted unanimously in favor of beti-cel – the company’s drug candidate for treatment of beta-thalassemia.
Beti-cel, one of company’s key programs, received strong support (13-0 vote) from the expert panel, with one member even suggesting “beti-cel could change the treatment paradigm for TDT,” as they unanimously agreed that treatment benefits outweigh the risks, and recommended the drug for approval.
The decision is now with the FDA – the potential green light may come within roughly two months, as beti-cel has a PDUFA date of August 19th, 2022.
Commenting on the vote, Morgan Stanley Matthew Harrison believes “investors will price-in at a minimum the ~$200M in value from the PRVs associated with approval.” He maintains caution and warns of “significant commercial risks” but nonetheless “expect a clear relief rally” in the shares, as he maintains an “Underweight” rating and $3 price target.
David Nierengarten of Wedbush calls the vote a “success for BLUE and its pipeline of LVV gene therapies.” He too shares a cautious tone with a “Neutral” rating but puts a more optimistic $8 price target on the stock.
The news comes in handy for the battered pharmaceutical company – prior to the announcement, shares of BLUE were down over 85% in one-year period and had recently recorded an all-time low of $2.87.