Lakefront Biotherapeutics Autoimmune Disorder Pemphigus Treatment Gets FDA Orphan Drug Designation

Dow Jones
3 hours ago
 
 

A Lakefront Biotherapeutics treatment for the autoimmune disorder pemphigus received orphan drug designation from the Food and Drug Administration.

The treatment, gamgertamig, is being developed in collaboration with Gilead Sciences. It previously received orphan drug and fast-track designations to treat autoimmune hemolytic anemia and immune thrombocytopenia.

Lakefront said clinical trials for the drug in various autoimmune diseases are actively enrolling and expected to expand next year.

"We're excited by the U.S. FDA's award of orphan drug designation for gamgertamig for the treatment of pemphigus as we continue to advance it for patients suffering with this debilitating and potentially life-threatening autoantibody-driven disease," Chief Medical Officer Eric Hedrick said.

The company also said Monday that it received a transparency notification from Bank of America that the bank now holds more than 10% of the company's voting rights.

 
 

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