10:57 AM EDT, 03/20/2024 (MT Newswires) -- Cabaletta Bio ( CABA ) said Wednesday the US Food and Drug Administration has given orphan drug designation to CABA-201 to potentially treat systemic sclerosis.

The candidate drug is being developed to treat autoimmune diseases driven by B cells, the company said, adding the clinical trial program has four phase 1/2 trials to assess the drug across several autoimmune diseases.

The regulator gives the designation to drugs to treat rare diseases that affect fewer than 200,000 people in the US, Cabaletta said.

The label makes Cabaletta eligible for incentives including partial tax credit for trial expenses, waived user fees and seven years of marketing exclusivity, the company said.

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