API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
The Company intends to use the net proceeds to accelerate commercialization of Libmeldy and advance the company’s HSC gene therapy R&D portfolio and approval of OTL-200 in the U.S. for metachromatic leukodystrophy (MLD), advancing its clinical and pre-clinical stage programs.
Lead Product(s): OTL-200
Therapeutic Area: Genetic Disease Product Name: OTL-200
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: RA Capital Management
Deal Size: $188.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 06, 2023
Details:
FDA has cleared the company’s Investigational New Drug application for OTL-200, an autologous, hematopoietic stem cell, lentiviral vector-based gene therapy in development for the treatment of metachromatic leukodystrophy.
Lead Product(s): OTL-200
Therapeutic Area: Genetic Disease Product Name: OTL-200
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
With the extension of the collaboration, MolMed will continue to support activities related to the development and manufacturing of vectors and drug products for several of Orchard’s investigational ex vivo hematopoietic stem cell (HSC) gene therapies in the upcoming years.
Lead Product(s): OTL-200
Therapeutic Area: Genetic Disease Product Name: OTL-200
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Orchard Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 09, 2020