Spexis AG Email Format
Pharmaceutical ManufacturingBasel-Landschaft, Switzerland11-50 Employees
Spexis AG is a publicly listed Swiss clinical-stage biopharmaceutical company focused on developing therapies for rare diseases and oncology, established in 2021 through a reverse merger of EnBiotix, Inc. and Polyphor AG and based in Allschwil in the Basel-Landschaft region. Its lead candidate, ColiFin®, is an inhaled formulation of colistimethate sodium licensed from PARI Pharma GmbH for ex-European rights and is approved and marketed in Europe as frontline therapy for cystic fibrosis. In the United States, ColiFin carries Orphan Drug and QIDP designations, providing twelve years of potential market exclusivity from NDA approval, and the FDA issued a Study May Proceed letter for a single Phase 3 trial intended to support an NDA, a design endorsed by the Cystic Fibrosis Foundation Therapeutic Development Network. In January 2024, Spexis entered into an asset purchase agreement with Basilea Pharmaceutica Ltd, reflecting ongoing strategic corporate development.