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FDA Clears Allogene's IND for CAR T Therapy in Autoimmune Diseases
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Allogene Therapeutics, Inc. (ALLO - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its investigational CRISPR-based allogenic CAR-T therapy, ALLO-329, for the treatment of various autoimmune diseases.
The phase I RESOLUTION basket study will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies and systemic sclerosis.
The study, which aims to offer a key understanding of ALLO-329's potential to transform the treatment paradigm across a range of autoimmune diseases, is expected to begin in mid-2025. The company expects to have proof-of-concept from the basket study by the end of 2025.
A next-generation allogeneic CAR T-cell therapy, ALLO-329, works by targeting both CD19+ B-cells and CD70+ activated T-cells. Additionally, the candidate incorporates ALLO’s proprietary Dagger technology, which is designed to reduce or eliminate the need for lymphodepletion.
In the past year, shares of Allogene have plunged 46.3% compared with the industry’s decline of 10.7%.
Image Source: Zacks Investment Research
ALLO's Other Pipeline Development Activities
The company is developing its lead candidate, cema-cel, in the pivotal phase II ALPHA3 study, as a potential first-line treatment for newly-diagnosed and treated large B cell lymphoma (LBCL) patients who are likely to relapse and need further therapy.
While management expects a data readout from the study by 2026-end, it expects to make a regulatory submission in 2027.
Apart from cema-cel, ALLO is also developing other allogeneic CAR T therapies for treating multiple myeloma, renal cell carcinoma and other cancer indications.
ALLO's Zacks Rank & Stocks to Consider
Allogene currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.22 for 2025. In the past year, shares of HRMY have rallied 18.5%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for BioMarin’s earnings per share have moved up from $3.94 to $4.02 for 2025. In the past year, shares of BMRN have plunged 29.5%.
BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 28.70%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.70 for 2025. In the past year, shares of CSTL have increased 12.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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FDA Clears Allogene's IND for CAR T Therapy in Autoimmune Diseases
Allogene Therapeutics, Inc. (ALLO - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its investigational CRISPR-based allogenic CAR-T therapy, ALLO-329, for the treatment of various autoimmune diseases.
The phase I RESOLUTION basket study will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies and systemic sclerosis.
The study, which aims to offer a key understanding of ALLO-329's potential to transform the treatment paradigm across a range of autoimmune diseases, is expected to begin in mid-2025. The company expects to have proof-of-concept from the basket study by the end of 2025.
A next-generation allogeneic CAR T-cell therapy, ALLO-329, works by targeting both CD19+ B-cells and CD70+ activated T-cells. Additionally, the candidate incorporates ALLO’s proprietary Dagger technology, which is designed to reduce or eliminate the need for lymphodepletion.
In the past year, shares of Allogene have plunged 46.3% compared with the industry’s decline of 10.7%.
Image Source: Zacks Investment Research
ALLO's Other Pipeline Development Activities
The company is developing its lead candidate, cema-cel, in the pivotal phase II ALPHA3 study, as a potential first-line treatment for newly-diagnosed and treated large B cell lymphoma (LBCL) patients who are likely to relapse and need further therapy.
While management expects a data readout from the study by 2026-end, it expects to make a regulatory submission in 2027.
Apart from cema-cel, ALLO is also developing other allogeneic CAR T therapies for treating multiple myeloma, renal cell carcinoma and other cancer indications.
ALLO's Zacks Rank & Stocks to Consider
Allogene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Harmony Biosciences Holdings, Inc. (HRMY - Free Report) , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.22 for 2025. In the past year, shares of HRMY have rallied 18.5%.
HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.
In the past 60 days, estimates for BioMarin’s earnings per share have moved up from $3.94 to $4.02 for 2025. In the past year, shares of BMRN have plunged 29.5%.
BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 28.70%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.70 for 2025. In the past year, shares of CSTL have increased 12.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.