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Allogene's (ALLO) CAR T Therapy Gets Fast Track Designation
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Allogene Therapeutics (ALLO - Free Report) announced that the FDA has granted Fast Track designation to its first AlloCAR T solid tumor clinical candidate, ALLO-316. The designation is granted to the candidate as a potential treatment for patients with advanced or metastatic clear cell renal cell carcinoma ("RCC").
Allogene is currently evaluating ALLO-316 in a phase I study for treating advanced or metastatic clear cell RCC.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs that treat serious and unmet medical conditions. Another potential benefit of the Fast Track tag is priority review, which lowers the standard review period of a new drug application from 10 months to six.
Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor ("CAR") T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.
Shares of Allogene have declined 41.6% so far this year compared with the industry’s decrease of 17%.
Image Source: Zacks Investment Research
The company currently has six pipeline candidates in early-stage of clinical development, including five AlloCAR T cell product candidates — ALLO-501, ALLO-501A, ALLO-715, ALLO-605 and ALLO-316 — and a monoclonal antibody (mAB), ALLO-647. Please note that the company utilizes ALLO-647 as part of its differentiated lymphodepletion regimen in clinical studies evaluating ALLO-501 or ALLO-715. The company resumed all clinical activities on these candidates earlier this month, following the removal of the clinical hold in January.
In October 2021, the FDA placed all its clinical studies evaluating AlloCAR T-based therapies on hold based on a report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating its next-generation, AlloCAR T candidate, ALLO-501A.
However, investigations concluded that chromosomal abnormality is not related to Allogene’s manufacturing process or the TALEN gene-editing technology and had no clinical significance.
Two different phase I studies are evaluating ALLO-501 and ALLO-501A across different oncology indications. Data from these studies presented last year demonstrated no relapses in CAR T naïve patients with large B cell lymphoma (“LBCL”) at six months following the treatment with either of the candidate. Based on these encouraging study data, Allogene plans to start a pivotal, phase II study — ALPHA2 — in mid-2022 to evaluate ALLO-501A in patients with relapsed/refractory LBCL.
The company is evaluating ALLO-715 and ALLO-605 in early-stage studies. Updated data from these studies are expected by the end of 2022.
Assertio’s earnings per share estimates have moved north from 20 cents to 35 cents for 2022 in the past 60 days. ASRT has gained 13.8% so far this year.
Assertio delivered an earnings surprise of 20.83%, on average, in the last four quarters.
Catalyst’s earnings per share estimates have improved from 50 cents to 71 cents for 2022 in the past 60 days. CPRX has risen 15.9% so far this year.
Catalyst delivered an earnings surprise of 30.56%, on average, in the last four quarters.
Estimates for Gamida have narrowed from a loss of $1.83 to $1.35 for 2022 in the past 60 days. GMDA has risen 48% so far this year.
Gamida delivered a negative earnings surprise of 22.6%, on average, in the last four quarters.
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Allogene's (ALLO) CAR T Therapy Gets Fast Track Designation
Allogene Therapeutics (ALLO - Free Report) announced that the FDA has granted Fast Track designation to its first AlloCAR T solid tumor clinical candidate, ALLO-316. The designation is granted to the candidate as a potential treatment for patients with advanced or metastatic clear cell renal cell carcinoma ("RCC").
Allogene is currently evaluating ALLO-316 in a phase I study for treating advanced or metastatic clear cell RCC.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs that treat serious and unmet medical conditions. Another potential benefit of the Fast Track tag is priority review, which lowers the standard review period of a new drug application from 10 months to six.
Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor ("CAR") T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.
Shares of Allogene have declined 41.6% so far this year compared with the industry’s decrease of 17%.
Image Source: Zacks Investment Research
The company currently has six pipeline candidates in early-stage of clinical development, including five AlloCAR T cell product candidates — ALLO-501, ALLO-501A, ALLO-715, ALLO-605 and ALLO-316 — and a monoclonal antibody (mAB), ALLO-647. Please note that the company utilizes ALLO-647 as part of its differentiated lymphodepletion regimen in clinical studies evaluating ALLO-501 or ALLO-715. The company resumed all clinical activities on these candidates earlier this month, following the removal of the clinical hold in January.
In October 2021, the FDA placed all its clinical studies evaluating AlloCAR T-based therapies on hold based on a report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating its next-generation, AlloCAR T candidate, ALLO-501A.
However, investigations concluded that chromosomal abnormality is not related to Allogene’s manufacturing process or the TALEN gene-editing technology and had no clinical significance.
Two different phase I studies are evaluating ALLO-501 and ALLO-501A across different oncology indications. Data from these studies presented last year demonstrated no relapses in CAR T naïve patients with large B cell lymphoma (“LBCL”) at six months following the treatment with either of the candidate. Based on these encouraging study data, Allogene plans to start a pivotal, phase II study — ALPHA2 — in mid-2022 to evaluate ALLO-501A in patients with relapsed/refractory LBCL.
The company is evaluating ALLO-715 and ALLO-605 in early-stage studies. Updated data from these studies are expected by the end of 2022.
Allogene Therapeutics, Inc. Price
Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Allogene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same sector include Assertio (ASRT - Free Report) , Catalyst Pharmaceuticals (CPRX - Free Report) and Gamida Cell . While Assertio sports a Zacks Rank #1 (Strong Buy), Catalyst and Gamida carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Assertio’s earnings per share estimates have moved north from 20 cents to 35 cents for 2022 in the past 60 days. ASRT has gained 13.8% so far this year.
Assertio delivered an earnings surprise of 20.83%, on average, in the last four quarters.
Catalyst’s earnings per share estimates have improved from 50 cents to 71 cents for 2022 in the past 60 days. CPRX has risen 15.9% so far this year.
Catalyst delivered an earnings surprise of 30.56%, on average, in the last four quarters.
Estimates for Gamida have narrowed from a loss of $1.83 to $1.35 for 2022 in the past 60 days. GMDA has risen 48% so far this year.
Gamida delivered a negative earnings surprise of 22.6%, on average, in the last four quarters.