Shares of bluebird bio (NASDAQ: BLUE) soared over 9% in pre-open Monday after the company’s “Abecma” therapy, developed together with Bristol-Myers Squibb (NYSE: BMY), received a green light from the U.S. Food and Drug Administration (FDA).

Abecma is the “first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody,” two companies said in a statement.

The therapy is a personalized immune cell therapy received as a one-time infusion.

“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb.

Mizuho’s analyst Difei Yang says the FDA approval represents an “important milestone ahead of multiple catalysts” in 2021 for BLUE.

“This represents an important milestone for bluebird bio in our view, given recent setbacks surrounding the company's gene therapy programs as well as prior delays for Ide-Cel, and also in the context of multiple recent negative FDA decisions in the industry. We believe this approval could give renewed comfort to investors and improve sentiment around the stock,” Yang wrote in a note sent to clients.

Mizuho recently upgraded BLUE to “Buy” following a safety update earlier this year around a case of AML in the sickle cell disease gene therapy program, the analyst said. He also raised the price target to $70.00 per share, signaling an upside of over 130% compared to Friday’s closing price.

BMO analyst Matthew Luchini also hiked the price target on BLUE to $35.00 per share from the old $31.00. The “Market Perform” rating is unchanged.

“We see no surprises in the label and expect focus to shift to commercial as well as label expansion opportunities into larger, earlier line multiple myeloma settings. We increase our target price to $35 from $31 as we increase our probability of success in 4L+ to 100% and update our model for Abecma's $419.5k cost. While Abecma's approval is positive, continued uncertainty around LentiGlobin and bluebird's ability to execute keep us on the sideline,” Luchini said in today's note.