Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that the FDA has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.
ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.
This designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the United States. ODD also include incentives including tax credits for clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity in the event of regulatory approval.
In April 2021, the candidate was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.
A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor,
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.
The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).
Shares of Allogene have declined 16.1% so far this year compared with the industry’s decrease of 0.3%.
While the CAR T space promises a lot of potential, competition is stiff. Earlier in the year, the FDA approved bluebird bio (BLUE - Free Report) / Bristol Myers Squibb (BMY - Free Report) ’s CAR T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.
Other approved CAR T cell therapies in the United States include Gilead’s (GILD - Free Report) Yescarta and Novartis’ Kymriah.
Allogene currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Allogene Therapeutics, Inc. (ALLO - Free Report) recently announced that the FDA has granted orphan-drug designation (ODD) to ALLO-715 for the treatment of multiple myeloma.
ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies.
This designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200,000 individuals in the United States. ODD also include incentives including tax credits for clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity in the event of regulatory approval.
In April 2021, the candidate was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.
A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ investigational gamma secretase inhibitor,
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.
The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC).
Shares of Allogene have declined 16.1% so far this year compared with the industry’s decrease of 0.3%.
While the CAR T space promises a lot of potential, competition is stiff. Earlier in the year, the FDA approved bluebird bio (BLUE - Free Report) / Bristol Myers Squibb (BMY - Free Report) ’s CAR T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.
Other approved CAR T cell therapies in the United States include Gilead’s (GILD - Free Report) Yescarta and Novartis’ Kymriah.
Allogene currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How To Profit From Trillions On Spending For Infrastructure >>
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