Shares of biotechnology company Cabaletta Bio (NASDAQ:CABA) are rising upward today after the U.S. Food and Drug Administration (FDA) greenlighted the company’s investigational new drug application (IND) for CABA-201.
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CABA-201 is an investigational CAR T cell therapy and now the company aims to begin a Phase 1/2 trial of the drug for treating systemic lupus erythematosus (SLE) for patients with systemic erythematosus (SLE) or active SLE sans renal involvement.
Importantly, the application got a clearance within 6 months of licensing the binder for the drug and Cabaletta now expects three-month clinical data on efficacy and tolerability for the therapy by the first half of 2024.
SLE impacts about 160,000 to 320,000 people in the U.S. Overall, Wall Street has a $14.17 consensus price target on CABA pointing to a hefty 99.58% potential upside in the stock. That’s on top of a 244% surge in the share price over the past year.
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