Failed Phase III For NeoCart May Still Fly With US FDA, Histogenics Argues
Agency guidance does not require coprimary, dual responder endpoint for drugs developed for knee cartilage repair, so in Histogenics' view, door is still open for approval.
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In July Histogenics Corp. raised $49 million in a Series A recap round that will help it complete a Phase III clinical trial in articular cartilage repair. The deal also shows that Histogenics’ novel strategy for getting through the mid-stage funding gap was a success.