Enzyvant Announces Plans to Expand Regenerative Medicine Manufacturing Capabilities

Enzyvant, a commercial-stage biotechnology company with a focus on regenerative medicines for rare diseases, announced today plans to develop a Good Manufacturing Practice (GMP)-compliant regenerative medicine manufacturing facility in Morrisville, NC, part of the Research Triangle Park area. “Enzyvant is committed to ensuring scalable GMP manufacturing for RETHYMIC® (allogeneic processed thymus tissue-agdc), and we’re looking ahead […]

Enzyvant Appoints Johanna Rossell as Chief Commercial Officer

Industry veteran brings extensive experience including tissue-based and regenerative therapies CAMBRIDGE, Mass. & BASEL, Switzerland, January 26, 2022 (GLOBE NEWSWIRE) — Enzyvant today announced the appointment of Johanna Rossell as Chief Commercial Officer. Johanna Rossell has an extensive background in the pharmaceutical and healthcare sector, leading multifunctional teams across several geographic markets around the world. […]

Enzyvant Receives FDA Approval for RETHYMIC® (allogeneic processed thymus tissue-agdc), a One-Time Regenerative Tissue-Based Therapy for Pediatric Congenital Athymia

RETHYMIC is the first and only FDA-approved treatment indicated for immune reconstitution in pediatric patients with congenital athymia Children with congenital athymia are born without a thymus causing severe immunodeficiency and immune dysregulation – with only supportive care they typically die by age two or three RETHYMIC clinical trials included 105 patients, a data set […]

Enzyvant Announces First-Ever Data on Burden of Illness and Costs of Supportive Care for Pediatric Congenital Athymia

On average, pediatric congenital athymia patients spent 150.6 days each year in the hospital with a mean total cost of $5,534,121 for supportive care over three years Mean total costs for patients with annual inpatient stays of 365 days are $11,763,320 over three years When treated with supportive care, patients with congenital athymia endure numerous, […]

Enzyvant Announces Publication of Positive Clinical Data in Pediatric Patients with Congenital Athymia Treated with Investigational RVT-802 (allogeneic processed thymus tissue-agdc)

Kaplan-Meier estimated survival at one year and two years post treatment with investigational RVT-802 was 77% and 76%, respectively Follow-up time in the Efficacy Analysis Set (EAS) ranged from 0 to 25.5 years; For patients who were alive at one year post treatment, the Kaplan-Meier estimated long-term survival rate was 93% at a median follow-up time […]

Aceragen Launches with Acquisition of Enzyvant‘s Investigational Therapy for Farber Disease and $35 Million Product Financing with NovaQuest

Acquires worldwide rights to RVT-801, a novel enzyme replacement therapy for treatment of Farber disease NovaQuest investment to fund product and clinical development Protocol for potential single registration study reviewed with FDA and EMA Program has been granted rare pediatric disease status, fast track and orphan designations, and is eligible for a priority review voucher once […]

ENZYVANT Resubmits Biologics Licensing Application (BLA) to FDA for RVT-802 for Pediatric Congenital Athymia

CAMBRIDGE, Mass., April 27, 2021 (GLOBE NEWSWIRE) — Enzyvant today announced the resubmission of the Biologics Licensing Application (BLA) to the U.S. Food and Drug Administration (FDA) for RVT-802, cultured human thymus tissue. RVT-802 is a one-time tissue-based regenerative therapy for the treatment of pediatric patients with congenital athymia. The FDA made several regulatory requests […]

Enzyvant Appoints Jeb Ledell as Chief Operating Officer

Former COO of Compass and Horizon Discovery joins Enzyvant as company nears first potential drug approval CAMBRIDGE, Mass. & BASEL, Switzerland–(BUSINESS WIRE)–Enzyvant, a biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare, life-threatening conditions, today announced the appointment of Jeb Ledell as Chief Operating Officer. Mr. Ledell previously served as Chief […]

Enzyvant Announces FDA Acceptance of Biologics License Application (BLA) and Priority Review Status for RVT-802, a Novel Investigational Tissue-Based Regenerative Therapy for Pediatric Congenital Athymia

RVT-802, a one-time therapy, leverages Enzyvant’s T cell generation platform designed to treat profound immunodeficiencies Left untreated, congenital athymia is uniformly fatal, with death typically occurring in first 24 months of life Company to present at Roivant Pipeline Day in New York City on June 6, 2019 CAMBRIDGE, Mass. & BASEL, Switzerland–(BUSINESS WIRE)–Enzyvant, a biopharmaceutical company […]