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Protalix BioTherapeutics

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Protalix BioTherapeutics Completes Treatment Period for its Phase III BRIGHT Clinical Trial of Pegunigalsidase Alfa in Fabry Disease

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

Details:

The BRIGHT study is a phase III, open label, switch over study to assess the safety, efficacy and pharmacokinetics of pegunigalsidase alfa 2 mg/kg administered by intravenous infusion in patients with Fabry disease currently treated with enzyme replacement therapy (ERT).

Protalix BioTherapeutics

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Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. FDA Acceptance of BLA for Pegunigalsidase Alfa

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: PRX-102

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2020

Details:

U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.

Prilenia therapeutics

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ISRAEL Israel

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Prilenia Therapeutics Raises $62.5M to Fund Late Stage Trials In HD and ALS

Lead Product(s): Pridopidine

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Morningside Venture

Deal Size: $62.5 million Upfront Cash: Undisclosed

Deal Type: Series A Financing June 03, 2020

Details:

The proceeds will fund two late-stage trials, which could lead to the registration of pridopidine for the treatment of HD and ALS. Pridopidine is a highly selective sigma-1 receptor (S1R) agonist.

Protalix BioTherapeutics

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ISRAEL Israel

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Protalix BioTherapeutics and Chiesi Global Rare Diseases Submits BLA to U.S. Food and Drug Administration for Pegunigalsidase Alfa

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 28, 2020

Details:

The BLA has been filed for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa a long-acting recombinant, PEGylated, cross-linked α-galactosidase-A product.

Protalix BioTherapeutics

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Protalix BioTherapeutics Announces Topline Results from the BRIDGE Phase III Open-Label Trial of Pegunigalsidase Alfa in Fabry Disease

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

The BRIDGE study was a Phase III study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa.

Protalix BioTherapeutics

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Protalix BioTherapeutics Announces $43.7 Million in Financing

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Psagot Investment House

Deal Size: $43.7 million Upfront Cash: Undisclosed

Deal Type: Financing March 12, 2020

Details:

Financing will advance the Company's clinical programs and commercialization of PRX-102 for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics.

Protalix BioTherapeutics

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Protalix Presents Key Clinical Data of Pegunigalsidase Alfa

Lead Product(s): Pegunigalsidase alfa

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 10, 2020

Details:

Phase I/II dose-ranging studies show high correlation between two Fabry disease biomarkers, supporting potential effectiveness of pegunigalsidase alfa in treating Fabry disease.

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Protalix BioTherapeutics

Protalix BioTherapeutics Completes Treatment Period for its Phase III BRIGHT Clinical Trial of Pegunigalsidase Alfa in Fabry Disease

Protalix BioTherapeutics

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. FDA Acceptance of BLA for Pegunigalsidase Alfa

Prilenia therapeutics

Prilenia Therapeutics Raises $62.5M to Fund Late Stage Trials In HD and ALS

Protalix BioTherapeutics

Protalix BioTherapeutics and Chiesi Global Rare Diseases Submits BLA to U.S. Food and Drug Administration for Pegunigalsidase Alfa

Protalix BioTherapeutics

Protalix BioTherapeutics Announces Topline Results from the BRIDGE Phase III Open-Label Trial of Pegunigalsidase Alfa in Fabry Disease

Protalix BioTherapeutics

Protalix BioTherapeutics Announces $43.7 Million in Financing

Protalix BioTherapeutics

Protalix Presents Key Clinical Data of Pegunigalsidase Alfa