X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
Details:
The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing approved therapy.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PTX3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neovacs
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 03, 2022
Details:
PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Musculoskeletal Product Name: Lyvispah
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
PXT3003 is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day used in Charcot-Marie-Tooth Disease Type 1A.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2021
Details:
This financing agreement for up to 81 million euros will enable Pharnext to strengthen its cash position and continue to develop its pivotal Phase III clinical trial of PXT3003, the PREMIER trial, in Charcot-Marie-Tooth disease type 1A (CMT1A).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alpha Blue Ocean
Deal Size: $96.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 10, 2021
Details:
The new results announced today continue to show sustained treatment benefits for CMT1A patients treated with PXT3003 at High Dose (‘HD’) in the PLEO-CMT-FU Period 2 trial with a data readout at 54 months of total trial time (double-blind + open-label).
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
The primary objective of this collaboration is to identify and validate potential treatment responsive CMT1A biomarkers that could be further explored in future clinical studies, in particular the upcoming Phase III study of PXT3003, Pharnext’s lead drug candidate.
Lead Product(s): Baclofen,Naltrexone,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: PXT3003
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pharnext
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 03, 2020
Details:
PXT3003 is a novel drug candidate for the treatment of CMT1A and has been granted both Orphan Drug Designation and Fast Track Designation by the US Food and Drug Administration.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
All existing data indicate that PXT3003 is a safe and well tolerated drug combination.
Lead Product(s): Baclofen,Naltrexone Hydrochloride,Sorbitol API
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
