Shares of Enochian Biosciences Inc ENOB were trading more than 75% higher Monday in reaction to the company's announcement regarding a positive FDA meeting regarding its HIV candidate.
What Happened: The company said its Initial Targeted Engagement for Regulatory Advice, or INTERACT, meeting with the FDA that was meant to discuss the pathway forward for its HIV treatment candidate ENOB-HV-01 turned out to be very successful, with strong alignment between its approach and the comments of the FDA reviewers.
The company focuses on gene-modified cellular and immune therapies targeting infectious diseases and cancer.
ENOB-HV-01 is a novel approach to autologous stem cell transplantation, with the potential to cure HIV by increasing engraftment of gene-modified cells that are resistant to HIV infection, according to the company.
What's Next: Enochian said it looks forward to advancing its pre-clinical work during the remainder of the year and into early next year. The company is targeting a pre-IND submission in 2021.
"The novel approach we are pursuing has the potential to overcome the challenges of engraftment commonly encountered by others in the field," Dr. David Hardy, chair of Enochian BioSciences' Scientific Advisory Board, said in a statement.
"While still early, thus far the data have exceeded my expectations, and I believe the FDA reviewer feedback was very much aligned with our development plan."
ENOB Price Action
At last check, Enochian shares were jumping 81.8% to $7.49.
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