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NGEN 资讯
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NervGen Doses First Participant in RESTORE Study
NervGen announced that the first participant has been dosed in RESTORE, a Phase 3 registrational study evaluating NVG-291 in individuals living with chronic cervical motor-incomplete SCI. NervGen anticipates completing enrollment in the second half of 2027 and reporting topline data in the first half of 2028.
NervGen Advances RESTORE Clinical Trial
"With FDA alignment and funding to support RESTORE now in place, we have expanded our organization with experienced professionals who understand the operational demands of late-stage clinical development and have the experience and judgement required to execute successfully. We are now advancing a coordinated site activation strategy and preparing to begin screening and enrollment across multiple centers," said Adam Rogers, MD, President and Chief Executive Officer of NervGen. "For the SCI community, RESTORE represents a rare and important registrational study of a pharmacologic candidate in individuals living with chronic SCI. September also marks SCI Awareness Month and will include an externally led Patient-Focused Drug Development meeting, providing a notable forum to elevate the perspectives and priorities of individuals living with SCI."
NervGen Pharma Files $250M Mixed Securities Shelf
NervGen Pharma files $250M mixed securities shelf
NervGen Pharma NVG-291 Shows Positive Neural Recovery Results
NervGen Pharma announced positive independent, blinded biomechanical gait analyses demonstrating genuine neural recovery with NVG-291 in the Phase 1b/2a CONNECT SCI study. Key highlights: NVG-291 demonstrated statistically significant improvement in gait quality, based on a Global Statistical Test integrating the established hallmarks of genuine neural recovery into a unified assessment of treatment benefit. Based on the Global Statistical Test, 100% of NVG-291 subjects were classified as responders across the composite of the hallmarks of genuine neural recovery, versus 10% of placebo subjects. These biomechanical gait findings join reported improvements in electrophysiological signaling, functional hand use, and quality of life, reflecting a consistent, multi-domain pattern of benefit with NVG-291 in the Phase 1b/2a CONNECT SCI study.
Leerink Partners and TD Cowen Jointly Manage Offering
Leerink Partners and TD Cowen are acting as joint bookrunning managers for the offering.
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