Clinical trial setbacks and financial challenges have led Finch Therapeutics to stop a Phase 3 study for its lead microbiome program, a potential treatment for recurrent C. diff infection. As Finch seeks buyers for its remaining assets, the biotech is laying off most of its staff in a corporate restructuring.
Bluebird Bio gene therapy Skysona has won FDA approval, making it the first FDA-approved therapy for cerebral adrenoleukodystrophy, an ultra-rare and fatal neurological disorder. Skysona’s regulatory green light follows the August approval of Zynteglo, a Bluebird gene therapy for a rare blood disorder.
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The agreement termination means that two preclinical microbiome therapy candidates for inflammatory bowel disease will now return to Finch Therapeutics. The biotech company had been collaborating with Takeda Pharmaceutical since 2017.
FDA approval of Bluebird Bio’s Zynteglo makes it the first gene therapy in the U.S. for the rare blood disorder beta thalassemia. The biotech company set a $2.8 million price for the one-time treatment, but it also came up with a reimbursement strategy designed to ease the financial risk to payers.
The startup has developed smart sensor mat that is designed to be placed in a patient's home and can analyze foot temperature variations to predict and prevent the occurrence of a potential ulcer.