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GeneVentiv Therapeutics Advances Hemophilia Gene Therapy Following Positive FDA Interaction

30 Oct 2025
Admin
News Article

GeneVentiv Therapeutics Advances Hemophilia Gene Therapy Following Positive FDA Interaction

GeneVentiv Therapeutics, Inc., a biotechnology company developing one-time gene therapies for rare and inherited diseases, announced that it has held a successful INTERACT meeting with the U.S. Food and Drug Administration (FDA) for its lead candidate, GENV-HEM — a novel gene therapy for Hemophilia A, with or without inhibitors to Factor VIII.

The meeting established alignment on IND-enabling studies and CMC strategy, marking an important regulatory milestone for the company.

“This positive and constructive meeting with the FDA represents a key regulatory milestone for GeneVentiv,” said Damon Race, Chief Executive Officer of GeneVentiv Therapeutics. “The Agency’s confirmation of our IND-enabling plan validates the rigor of our scientific and manufacturing approach and provides a clear path toward first-in-human studies.”

Dr. Paris Margaritis, Chief Scientific Officer, added that GENV-HEM has shown robust preclinical activity, with potential to meet unmet needs in patients through durable endogenous Factor Va expression.

Next Steps

GeneVentiv plans to continue engagement with the FDA as it progresses through IND-enabling studies, with a Pre-IND meeting and IND submission targeted for 2026.

About GeneVentiv Therapeutics

GeneVentiv Therapeutics develops transformative gene therapies for rare and serious diseases.

Lead program: GENV-HEM — an AAV-based therapy designed as a one-time treatment for Hemophilia A patients, including those with inhibitors.
Second program: GENV-002 — a dual-vector CRISPR gene-editing therapy targeting both Infantile and Late-Onset Pompe disease.

The company’s mission is to pioneer gene therapies that reach every patient within a disease area, expanding access beyond limited subgroups.