Kolon TissueGene, Inc.
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Latest From Kolon TissueGene, Inc.
Novartis has added an anti-osteoarthritic Nanobody, M6495, to its growing pipeline of candidates for the condition, in a €450m agreement with Merck KGaA that sees the latter deliver on its plans to find new homes for its osteoarthritis pipeline.
Following the long-awaited decision from the US FDA, Kolon TissueGene will resume Phase III clinical trials of the cell and gene therapy for degenerative osteoarthritis TG-C (Invossa) in the US this year.
Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.
South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.
- Gene Therapy, Cell Therapy
- Other Names / Subsidiaries
- TissueGene, Inc.