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Nkarta (NKTX) Rallies 112% as FDA Clears IND for Lupus Drug
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Nkarta, Inc. (NKTX - Free Report) announced that the FDA has cleared the investigational new drug (IND) application to move its investigational candidate, NKX019, into clinical studies for the treatment of lupus nephritis (LN), an autoimmune disease. The company’s stock swiftly surged 112.2% on Tuesday in response.
NKX019 is Nkarta’s allogeneic and CD19-directed CAR NK cell therapy candidate, which uses the NK cell-based approach to make cell therapies for autoimmune diseases, such as LN, through improved access and tolerability.
Following the IND clearance, the planned dose escalation clinical study will evaluate the safety and clinical activity of NKX019 in patients with refractory LN. Per Nkarta, patients enrolled in the proposed study will be divided into two cohorts receiving three doses of NKX019 at 1 billion or 1.5 billion cells per dose on Days 0, 7 and 14.
Before treatment with NKX019, patients enrolled in the early-stage study will undergo lymphodepletion with single-agent cyclophosphamide, an agent with an established safety profile in systemic lupus erythematosus (SLE) and LN.
The company plans to enroll up to 12 patients in the study. The first patient is expected to be enrolled in the first half of 2024. A clinical update from the study is also anticipated in 2024.
Year to date, shares of Nkarta have lost 47.5% compared with the industry’s 18.4% fall.
Image Source: Zacks Investment Research
LN is a severe case of SLE, an autoimmune disease characterized by abnormal B cell function and autoantibody production. Per NKTX, 40% of the approximately 200,000 patients in the United States, who have been diagnosed with SLE, develop LN. Furthermore, a significant percentage of LN patients progress to end-stage kidney disease, which is often fatal. This represents a serious unmet medical need.
Nkarta is also currently evaluating NKX019 in other B cell-derived malignancy indications in clinical studies. An update from the study is expected in mid-2024.
In the same press release, the company reported several cost-saving measures as part of its corporate update to extend its projected cash runway into 2026 while advancing its multiple cell therapy programs.
The company is planning to cut down its workforce and limit the number of new hires in the future as part of its cost-saving measures. Nkarta is also looking to centralize its operations to a single location and optimize its manufacturing platform to ensure early success.
In a separate press release, Lupus Therapeutics, a subsidiary of Lupus Research Alliance, announced a collaboration with Nkarta to provide the latter with advisory services and support to accelerate the early-stage development of NKX109 to treat LN.
Apart from NKX019, NKTX has another clinical-stage candidate, NKX101, which is currently undergoing early-stage development for the treatment of acute myelogenous leukemia (AML). NKX101 is the company’s allogeneic and off-the-shelf CAR NK cell therapy candidate.
Nkarta is currently enrolling additional patients in the AML study and expects to report preliminary safety and response datafrom these additional patients in the first half of 2024.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 22 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 8 cents. Year to date, shares of DVAX have gained 35.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 33 cents to 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 38 cents to 37 cents. Year to date, shares of ANIX have lost 19.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. In the past year, shares of ACET have decreased by 83.2%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.
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Nkarta (NKTX) Rallies 112% as FDA Clears IND for Lupus Drug
Nkarta, Inc. (NKTX - Free Report) announced that the FDA has cleared the investigational new drug (IND) application to move its investigational candidate, NKX019, into clinical studies for the treatment of lupus nephritis (LN), an autoimmune disease. The company’s stock swiftly surged 112.2% on Tuesday in response.
NKX019 is Nkarta’s allogeneic and CD19-directed CAR NK cell therapy candidate, which uses the NK cell-based approach to make cell therapies for autoimmune diseases, such as LN, through improved access and tolerability.
Following the IND clearance, the planned dose escalation clinical study will evaluate the safety and clinical activity of NKX019 in patients with refractory LN. Per Nkarta, patients enrolled in the proposed study will be divided into two cohorts receiving three doses of NKX019 at 1 billion or 1.5 billion cells per dose on Days 0, 7 and 14.
Before treatment with NKX019, patients enrolled in the early-stage study will undergo lymphodepletion with single-agent cyclophosphamide, an agent with an established safety profile in systemic lupus erythematosus (SLE) and LN.
The company plans to enroll up to 12 patients in the study. The first patient is expected to be enrolled in the first half of 2024. A clinical update from the study is also anticipated in 2024.
Year to date, shares of Nkarta have lost 47.5% compared with the industry’s 18.4% fall.
Image Source: Zacks Investment Research
LN is a severe case of SLE, an autoimmune disease characterized by abnormal B cell function and autoantibody production. Per NKTX, 40% of the approximately 200,000 patients in the United States, who have been diagnosed with SLE, develop LN. Furthermore, a significant percentage of LN patients progress to end-stage kidney disease, which is often fatal. This represents a serious unmet medical need.
Nkarta is also currently evaluating NKX019 in other B cell-derived malignancy indications in clinical studies. An update from the study is expected in mid-2024.
In the same press release, the company reported several cost-saving measures as part of its corporate update to extend its projected cash runway into 2026 while advancing its multiple cell therapy programs.
The company is planning to cut down its workforce and limit the number of new hires in the future as part of its cost-saving measures. Nkarta is also looking to centralize its operations to a single location and optimize its manufacturing platform to ensure early success.
In a separate press release, Lupus Therapeutics, a subsidiary of Lupus Research Alliance, announced a collaboration with Nkarta to provide the latter with advisory services and support to accelerate the early-stage development of NKX109 to treat LN.
Apart from NKX019, NKTX has another clinical-stage candidate, NKX101, which is currently undergoing early-stage development for the treatment of acute myelogenous leukemia (AML). NKX101 is the company’s allogeneic and off-the-shelf CAR NK cell therapy candidate.
Nkarta is currently enrolling additional patients in the AML study and expects to report preliminary safety and response datafrom these additional patients in the first half of 2024.
Nkarta, Inc. Price and Consensus
Nkarta, Inc. price-consensus-chart | Nkarta, Inc. Quote
Zacks Rank and Stocks to Consider
Nkarta currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) , Anixa Biosciences (ANIX - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While DVAX sports a Zacks Rank #1 (Strong Buy), ANIX and ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 22 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 8 cents. Year to date, shares of DVAX have gained 35.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 33 cents to 32 cents. The estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 38 cents to 37 cents. Year to date, shares of ANIX have lost 19.3%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 26.29%.
In the past 30 days, the estimate for Adicet Bio’s 2023 loss per share has remained constant at $2.93. The estimate for Adicet’s 2024 loss per share has remained constant at $2.40. In the past year, shares of ACET have decreased by 83.2%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 7.70%.