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Cartesian (RNAC) Up as FDA Grants RMAT Tag to Descartes-08
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Cartesian Therapeutics, Inc. (RNAC - Free Report) announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its lead pipeline candidate, Descartes-08, for the treatment of myasthenia gravis (“MG”), an autoimmune disease associated with muscle weakness. Shares of the company were up 3.5% on May 22 following the announcement of the news.
The RMAT designation is generally granted by the FDA to therapies that are intended to treat or cure a serious or life-threatening disease and have the potential to address unmet medical needs. It enables early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.
Cartesian is currently evaluating Descartes-08 in a double-blind, placebo-controlled, phase IIb study for the treatment of patients with generalized myasthenia gravis. Top-line data from the same is expected by the middle of the ongoing year.
In January 2024, Cartesian reported positive 12-month follow-up data from a phase IIa study evaluating Descartes-08 in patients with generalized MG.
Data from the same showed that treatment with Descartes-08 was generally well-tolerated, with no dose-limiting toxicities, cytokine release syndrome or neurotoxicity.
Previously, the regulatory body had granted an Orphan Drug Designation to Descartes-08 for the treatment of MG.
Shares of Cartesian have rallied 23% so far this year against the industry’s decline of 4.3%.
Image Source: Zacks Investment Research
Descartes-08 is an autologous anti-B cell maturation antigen mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) that is being developed for treating various types of autoimmune diseases.
Descartes-08 is also being developed for treating systemic lupus erythematosus (SLE), an incurable autoimmune disease. The company plans to dose the first patient in a phase II study on Descartes-08 in patients with SLE shortly.
Cartesian currently does not have any approved product in its portfolio. Hence, in the absence of a marketed product, the successful development of Descartes-08 and other pipeline candidates remains the key focus area for this clinical-stage company.
Zacks Rank & Stocks to Consider
Cartesian currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 36.5%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 88.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 59.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.
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Cartesian (RNAC) Up as FDA Grants RMAT Tag to Descartes-08
Cartesian Therapeutics, Inc. (RNAC - Free Report) announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its lead pipeline candidate, Descartes-08, for the treatment of myasthenia gravis (“MG”), an autoimmune disease associated with muscle weakness. Shares of the company were up 3.5% on May 22 following the announcement of the news.
The RMAT designation is generally granted by the FDA to therapies that are intended to treat or cure a serious or life-threatening disease and have the potential to address unmet medical needs. It enables early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.
Cartesian is currently evaluating Descartes-08 in a double-blind, placebo-controlled, phase IIb study for the treatment of patients with generalized myasthenia gravis. Top-line data from the same is expected by the middle of the ongoing year.
In January 2024, Cartesian reported positive 12-month follow-up data from a phase IIa study evaluating Descartes-08 in patients with generalized MG.
Data from the same showed that treatment with Descartes-08 was generally well-tolerated, with no dose-limiting toxicities, cytokine release syndrome or neurotoxicity.
Previously, the regulatory body had granted an Orphan Drug Designation to Descartes-08 for the treatment of MG.
Shares of Cartesian have rallied 23% so far this year against the industry’s decline of 4.3%.
Image Source: Zacks Investment Research
Descartes-08 is an autologous anti-B cell maturation antigen mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) that is being developed for treating various types of autoimmune diseases.
Descartes-08 is also being developed for treating systemic lupus erythematosus (SLE), an incurable autoimmune disease. The company plans to dose the first patient in a phase II study on Descartes-08 in patients with SLE shortly.
Cartesian currently does not have any approved product in its portfolio. Hence, in the absence of a marketed product, the successful development of Descartes-08 and other pipeline candidates remains the key focus area for this clinical-stage company.
Zacks Rank & Stocks to Consider
Cartesian currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) , Marinus Pharmaceuticals, Inc. (MRNS - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 36.5%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 88.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 59.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.