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bluebird-Bristol Myers' CAR T Cell Therapy BLA Accepted by FDA

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bluebird bio, Inc. (BLUE - Free Report) and Bristol Myers Squibb (BMY - Free Report) announced that the FDA has accepted for Priority Review their biologics license application (BLA) for their lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate, idecabtagene vicleucel  (ide-cel; bb2121). Shares of bluebird increased 1.98% following the news. However, shares of the company have declined 36.7% year to date against the industry’s growth of 1.3%. Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma.

The companies are seeking approval of the candidate for the treatment of adult patients with multiple myeloma (MM), having received a minimum of three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.Multiple myeloma is a cancer of plasma cells in the bone marrow. The FDA has set an action date of Mar 27, 2021.

The BLA is based on phase II KarMMa study evaluating the efficacy and safety of idecabtagene vicleucelin 128 adults with heavily pre-treated and highly refractory multiple myeloma exposed to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The primary endpoint of the study is the overall response rate and the complete response rate is a key secondary endpoint.

The companies filed the application in July 2020, after announcing in May that they had received a refuse-to-file letter from the FDA for the previously submitted application (in March) for the therapy due to chemistry, manufacturing and control issues.

We note that, in 2017, idecabtagene vicleucel was granted a Breakthrough Therapy designation by the FDA and the PRIority Medicines (PRIME) eligibility by the European Medicines Agency for the treatment of relapsed/refractory MM.

Further, bluebird announced that its investigational treatment for sickle cell disease (SCD), LentiGlobin (bb1111), was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA). Clinical data from the completed phase I/II HGB-205 study, the ongoing phase I/II HGB-206 study and the ongoing long-term safety and efficacy follow-up study, LTF-303, supported the PRIME application for LentiGlobin in SCD. EMA’s PRIME program is designed to optimize development and expedite evaluation of innovative medicines for patients with high unmet need.

Zacks Rank & Stocks to Consider

bluebird currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) and Bio Techne Corp (TECH - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 86.7% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 10.8% year to date.

 

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