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Allogene (ALLO) Multiple Myeloma Candidate Gets Fast Track Tag

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Allogene Therapeutics (ALLO - Free Report) announced that the FDA has granted Fast Track designation to its drug ALLO-605 for treatment of relapsed/refractory multiple myeloma.

ALLO-605 is Allogene’s next-generation allogeneic chimeric antigen receptor T cell (“AlloCAR T”) investigational therapy that targets the B-cell maturation antigen (“BCMA”) to treat patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies.

Fast Track is designed to facilitate the development, and speed up the review of drugs to treat serious conditions and fill an unmet medical need. ALLO-605’s fast track designation has been granted based on the drug’s potential to address unmet needs of patients who have failed other standard multiple myeloma therapies.

ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells.

A phase I IGNITE dose escalation study for the drug was initiated in second-quarter 2021. The company is exploring three AlloCAR T anti-BCMA therapies to treat relapsed or refractory multiple myeloma. Other than ALLO-605, Allogene is also evaluating ALLO-715 as a monotherapy and in combination with a gamma secretase inhibitor for treating this rapidly progressing disease.

In the year so far, Allogene’s stock has risen 3.3% in comparison with the industry’s rise of 1.2%.

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Both ALLO-605 and ALLO-715 utilize TALEN gene-editing technology developed and owned by Cellectis (CLLS - Free Report) . Allogene has an exclusive license to the technology, and the global development and commercial rights for allogeneic products directed at BCMA.

Allogene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the biotech sector include BioNTech (BNTX - Free Report) and Bayer (BAYRY - Free Report) . While BioNTech carries a Zacks Rank #1, Bayer currently carries a Zacks Rank #2 (Buy).

BioNTech’s earnings estimates for 2021 have increased from $18.39 to $30.58 per share in the past 60 days while that of 2022 has risen from $7.55 to $24.90 over the same period. The stock has surged 174.6% this year so far.

Bayer’s earnings estimates for 2021 have increased from $1.74 to $1.81 per share in the past 60 days while that of 2022 has risen from $1.89 to $2.00 over the same period. The stock has risen 2.7% in the year so far.

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