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Immix (IMMX) CAR-T Therapy IND Cleared by FDA, Stock Down
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Immix Biopharma, Inc. (IMMX - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its BCMA CAR-T cell therapy, NXC-201.
Per the company, the FDA clearance allows NEXICART-2 (NCT06097832) to expand clinical studies on NXC-201 for the treatment of relapsed/refractory AL amyloidosis in the United States. Currently, there are no approved treatments for the given indication.
Per the press release, the favorable tolerability profile of NXC-201 is likely to help Immix to explore and expand the studies of NXC-201 into other autoimmune diseases like systemic lupus erythematosus, myasthenia gravis and multiple sclerosis.
Also, this is the first CAR-T program, which is being studied for light-chain AL amyloidosis.
The company remains focused on beginning patient enrollment at multiple sites in the United States in the upcoming months.
Despite IND clearance by the FDA, shares of Immix were down 5% on Tuesday following the announcement of the news.
However, the stock has rallied 83% so far this year against the industry’s decline of 22.9%.
Image Source: Zacks Investment Research
In September 2023, the FDA granted Orphan Drug Designation (ODD) designation to NXC-201 for treating AL amyloidosis, a life-threatening blood disorder.
Also, in August, the FDA granted ODD to NXC-201 for treating multiple myeloma (blood cancer).
NXC-201 is currently being evaluated in a phase Ib/IIa clinical study, NEXICART-1 (NCT04720313), for treating adult patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. The candidate is being developed by Immix’s subsidiary, Nexcella, Inc.
Immix currently does not have any approved products in its portfolio. Therefore, in the absence of a marketed product, successful development and commercialization of NXC-201 remains the key focus of the company.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 18.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.33. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 12.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 9%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Immix (IMMX) CAR-T Therapy IND Cleared by FDA, Stock Down
Immix Biopharma, Inc. (IMMX - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its BCMA CAR-T cell therapy, NXC-201.
Per the company, the FDA clearance allows NEXICART-2 (NCT06097832) to expand clinical studies on NXC-201 for the treatment of relapsed/refractory AL amyloidosis in the United States. Currently, there are no approved treatments for the given indication.
Per the press release, the favorable tolerability profile of NXC-201 is likely to help Immix to explore and expand the studies of NXC-201 into other autoimmune diseases like systemic lupus erythematosus, myasthenia gravis and multiple sclerosis.
Also, this is the first CAR-T program, which is being studied for light-chain AL amyloidosis.
The company remains focused on beginning patient enrollment at multiple sites in the United States in the upcoming months.
Despite IND clearance by the FDA, shares of Immix were down 5% on Tuesday following the announcement of the news.
However, the stock has rallied 83% so far this year against the industry’s decline of 22.9%.
In September 2023, the FDA granted Orphan Drug Designation (ODD) designation to NXC-201 for treating AL amyloidosis, a life-threatening blood disorder.
Also, in August, the FDA granted ODD to NXC-201 for treating multiple myeloma (blood cancer).
NXC-201 is currently being evaluated in a phase Ib/IIa clinical study, NEXICART-1 (NCT04720313), for treating adult patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. The candidate is being developed by Immix’s subsidiary, Nexcella, Inc.
Immix currently does not have any approved products in its portfolio. Therefore, in the absence of a marketed product, successful development and commercialization of NXC-201 remains the key focus of the company.
Zacks Rank & Other Stocks to Consider
Immix currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are CytomX Therapeutics, Inc. (CTMX - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 18.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.33. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 12.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 9%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.