来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
Ocugen announced that the manufacturing facility for its regenerative cell therapy for cartilage, NeoCart, is expected for completion by the end of 2023. Image Credit: Sergey Nivens / Shutterstock. 来源: Pharmaceutical Technology
The plans follow the US Food and Drug Administration’s (FDA) approval of the Investigational New Drug (IND) application for the two gene therapies. 来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
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Ocugen is also planning for a Phase III trial in retinitis pigmentosa for OCU400 in Q4 2023/Q1 2024. The Phase III trial initiation is contingent on the FDA’s approval of trial plans and Phase I/II data. OCU400 is an adeno-associated virus serotype 5 capsid containing the gene for human nuclear hormone receptor NR2E3. It is being developed in partnership with China-based CanSinoBIO. It is currently being evaluated in an open-label Phase II trial (NCT05203939). Ocugen announced that the manufacturing facility for its regenerative cell therapy for cartilage, NeoCart, is expected for completion by the end of 2023, with a Phase III trial for the therapy planned for initiation in H2 2024. The US-based company is looking for government funding for its inhaled mucosal vaccine platform, with the IND application for the treatment expected to be filled in 2024.
As part of their second quarter financials, Ocugen reported cash equivalents of $70.6m on 30 June 2023. The company also reported a loss of $0.10 per common share in Q2 2023. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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Free WhitepaperCell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead.By Cytiva Thematic 来源: Pharmaceutical Technology
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