A pivotal Phase III study of rebonuputemce in patients with lumbar disc degeneration having pain and disability

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 15 Apr 2025

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At a glance

09 Apr 2025 According to a DiscGenics media release, Subject enrollment is expected to begin in Q2 2025.
16 Jul 2024 According to a DiscGenics media release, if successful, this Phase III clinical program will support a biologics license application (BLA) to be filed with the FDA.
16 Jul 2024 According to a DiscGenics media release, the US FDA has granted approval to procced with the phase III program of rebonuputemcel which consists of two identical studies running in parallel: the pivotal study (DGX-A02 or PIVOT) and the confirmatory study (DGX-A03 or CONFIRM). The first subject in the pivotal study is estimated to be enrolled during Q4 2024.

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