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ARTICLE | Regulation

Nov. 30 Quick Takes: Ferring’s Rebyota wins FDA approval 

Plus: Novo, Lyfe lead iECURE’s new round and updates from bluebird-argenx, Nimbus, Oncorus and more

December 1, 2022 1:47 AM UTC

Rebyota from Ferring Pharmaceuticals A/S became the first fecal microbiota product to win FDA approval, with the agency granting it authorization to prevent recurrence of Clostridioides difficile infection (CDI). Rebyota is prepared from stool donated by qualified individuals and administered rectally as a single dose. The drug was granted fast track, breakthrough therapy and orphan designations.

Novo Holdings A/S and Lyfe Capital have led a new $65 million series A-1 round for iECURE Inc. that is designed to fund the biotech’s first clinical study and move a second program toward the clinic. The company intends to begin a Phase I/II trial of gene editing therapy GTP-506 to treat ornithine transcarbamylase deficiency; the treatment uses two adeno-associated viral (AAV) vectors with different payloads. Backed in its $50 million series A by Versant Ventures and OrbiMed Advisors, both of which participated in the latest round, the biotech is also advancing programs for citrullinemia type 1 and phenylketonuria...

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