Here’s Why InVivo Therapeutics (NVIV) Stock Skyrocketed Today


Investors love biotech stocks for the lottery ticket-like returns they can offer if a company strikes medical gold. Case in point: Invivo Therapeutics (NASDAQ:NVIV), whose shares are jumping nearly 80% on Wednesday, as the Street praises the drug maker’s presentation of new positive clinical data at the 2018 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting.

Specifically, the company presented complete six-month primary endpoint results from its single-arm INSPIRE study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury). The presentation was given by Stuart Lee, M.D., Division of Neurosurgery, Vidant Health. The presentation was titled, “Complete 6-Month Primary Endpoint Results from the Prospective INSPIRE Study of the Investigational Neuro-Spinal Scaffold™ in Acute Thoracic Complete Spinal Cord Injury.” This is the first presentation at a medical meeting of the complete six-month data from the INSPIRE study.

As reported by Dr. Lee and previously announced by InVivo, 7 of 16 (44%) patients who reached the six-month primary endpoint visit in the INSPIRE study had an ASIA Impairment Scale (AIS) conversion at 6 months, which is the primary endpoint of the trial (defined as improvement in AIS grade from baseline for all evaluable patients at the six-month visit). Altogether, 19 patients have been implanted with the Neuro-Spinal Scaffold. Three patients died within two weeks of implantation. The Objective Performance Criterion (OPC) (study success definition) for the study was a 25% AIS conversion rate based on the published conversion rates for thoracic spinal cord injury (SCI) reported in the literature. The AANS presentation further reported these data in light of the company’s recently announced CONTEMPO study results. The CONTEMPO study was designed to provide comprehensive natural history benchmarks for Neuro-Spinal Scaffold™ clinical study results. The CONTEMPO study included neurological recovery data from 170 patients across three registries of SCI patients with similar baseline characteristics to those in the INSPIRE study and validated the company’s previously established OPC with AIS conversion rates at approximately six months post-injury of 16.7% – 23.4% across the three registries.

InVivo has officially closed the INSPIRE study and has received supplemental Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for a second pivotal clinical study of the company’s Neuro-Spinal Scaffold™ in patients with acute SCI. The 20-patient (10 subjects in each study arm), randomized, controlled trial is designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold™ from the company’s single-arm INSPIRE study.

“I was honored to present these clinical findings at the AANS Annual Scientific Meeting, and I believe the complete six-month INSPIRE findings encourage future clinical investigation of the Neuro-Spinal Scaffold,” said Dr. Lee.

NVIV has only received one analyst rating in the last three months. Raymond James analyst Reni Benjamin has a cautious hold rating on the stock without suggesting a price target.

 

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