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Arcellx (RCLX) Down on Hold for Lead Program CART-ddBCMA
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Shares of Arcellx, Inc. (ACLX - Free Report) moved down on Jun 20 after the company announced that the FDA placed a clinical hold on its iMMagine-1 program.
iMMagine-1 is a phase II, open-label, multicenter clinical trial designed to evaluate the lead program CART-ddBCMA for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM). CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy utilizing the company's novel BCMA-targeting binding domain.
The primary objective of this study is to evaluate the overall response rate over 24 months. In addition to safety, secondary endpoints include depth of disease response, duration of response and overall survival over a 24-month period.
The hold was placed on Jun 16 after a patient died. Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. Nevertheless, the regulatory body has given Arcellx clearance to continue dosing patients who have undergone lymphodepletion.
Shares of Arcellx have gained 5% in year to date against the industry’s decline of 7.2%.
Image Source: Zacks Investment Research
We note that Arcellx entered into a collaboration and license agreement with Gilead Sciences’ (GILD - Free Report) Kite Pharma for CART-ddBCMA.
Upon closing in January 2023, Gilead’s Kite made an upfront payment of $225.0 million and obtained a license to codevelop and co-commercialize CART-ddBCMA for the treatment of multiple myeloma. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the United States and Kite will commercialize the product outside the United States.
Arcellx also granted Kite the ability to negotiate a development and commercialization license for the inclusion of a limited number of pre-specified additional autologous CAR-T-cell therapy products for treating multiple myeloma, which can only be exercised by Kite after the company provides a phase I clinical study report to Kite.
CART-ddBCMA has been granted Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy Designations by the FDA.
Arcellx is also developing two clinical-stage ARC-SparX programs in phase I studies, ACLX-001, which targets BCMA in rrMM and wholly owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Arcellx (RCLX) Down on Hold for Lead Program CART-ddBCMA
Shares of Arcellx, Inc. (ACLX - Free Report) moved down on Jun 20 after the company announced that the FDA placed a clinical hold on its iMMagine-1 program.
iMMagine-1 is a phase II, open-label, multicenter clinical trial designed to evaluate the lead program CART-ddBCMA for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM). CART-ddBCMA is Arcellx's BCMA-specific CAR-modified T-cell therapy utilizing the company's novel BCMA-targeting binding domain.
The primary objective of this study is to evaluate the overall response rate over 24 months. In addition to safety, secondary endpoints include depth of disease response, duration of response and overall survival over a 24-month period.
The hold was placed on Jun 16 after a patient died. Arcellx believes limitations on bridging therapy are a contributing factor and is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. Nevertheless, the regulatory body has given Arcellx clearance to continue dosing patients who have undergone lymphodepletion.
Shares of Arcellx have gained 5% in year to date against the industry’s decline of 7.2%.
Image Source: Zacks Investment Research
We note that Arcellx entered into a collaboration and license agreement with Gilead Sciences’ (GILD - Free Report) Kite Pharma for CART-ddBCMA.
Upon closing in January 2023, Gilead’s Kite made an upfront payment of $225.0 million and obtained a license to codevelop and co-commercialize CART-ddBCMA for the treatment of multiple myeloma. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the United States and Kite will commercialize the product outside the United States.
Arcellx also granted Kite the ability to negotiate a development and commercialization license for the inclusion of a limited number of pre-specified additional autologous CAR-T-cell therapy products for treating multiple myeloma, which can only be exercised by Kite after the company provides a phase I clinical study report to Kite.
CART-ddBCMA has been granted Fast Track, Orphan Drug and Regenerative Medicine Advanced Therapy Designations by the FDA.
Arcellx is also developing two clinical-stage ARC-SparX programs in phase I studies, ACLX-001, which targets BCMA in rrMM and wholly owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
Zacks Rank & Stocks to Consider
Arcellx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . LGND currently sports a Zacks Rank #1 (Strong Buy) and Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for LGND have increased by 86 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.74 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.