Histogenics historically focused on the development of restorative cell therapies, including its product candidate, NeoCart, which is an innovative cell therapy that utilizes various aspects of Histogenicsâ restorative cell therapy platform to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In the third quarter of 2018, Histogenics announced that its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture. Based on the totality of the data, Histogenics initiated a dialogue with the FDA in the third quarter of 2018 to discuss the regulatory path forward for NeoCart. Histogenicsâ primary objective in these discussions was to determine whether the FDA would accept a submission of a BLA for NeoCart without data from an additional clinical trial. Histogenics had a constructive dialogue with the FDA, which included requests for, and review of, additional statistical analyses, different subgroup analyses, and secondary endpoints. These additional analyses did not change the conclusion that the NeoCart Phase 3 trial failed to meet its primary and secondary endpoints. Source
No articles found.
Cerus Corporation is dedicated solely to safeguarding the worldâs blood supply a...
Cerus Corporation is dedicated solely to safegu...
The Medicines Company is a biopharmaceutical company driven by an overriding purpo...
The Medicines Company is a biopharmaceutical co...
Viveve, Inc., the wholly owned subsidiary of Viveve Medical, Inc., is a women's in...
Viveve, Inc., the wholly owned subsidiary of Vi...
The next evolution in DNA-based diagnostics. MicroGen Vet is the exclusive reselle...
The next evolution in DNA-based diagnostics. Mi...
Inogenâs mission to improve the quality of life of supplemental oxygen users beg...
Inogenâs mission to improve the quality of li...
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on deve...
Aptevo Therapeutics Inc. is a clinical-stage bi...
Iovance Biotherapeutics (formerly traded as Lion Biotechnologies) is focused on th...
Iovance Biotherapeutics (formerly traded as Lio...
Join the National Investor Network and get the latest information with your interests in mind.