[{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix Presents Key Clinical Data of Pegunigalsidase Alfa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Psagot Investment House","pharmaFlowCategory":"D","amount":"$43.7 million","upfrontCash":"Undisclosed","newsHeadline":"Protalix BioTherapeutics Announces $43.7 Million in Financing","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics Announces Topline Results from the BRIDGE Phase III Open-Label Trial of Pegunigalsidase Alfa in Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics and Chiesi Global Rare Diseases Submits BLA to U.S. Food and Drug Administration for Pegunigalsidase Alfa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Chiesi Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce U.S. FDA Acceptance of BLA for Pegunigalsidase Alfa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics Completes Treatment Period for its Phase III BRIGHT Clinical Trial of Pegunigalsidase Alfa in Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Launch of Expanded Access Program in the U.S for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Protalix BioTherapeutics","sponsor":"Chiesi Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Regulatory Update on PRX-102 for the Treatment of Fabry Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Protalix BioTherapeutics"},{"company":"Prilenia therapeutics","sponsor":"Morningside Venture","pharmaFlowCategory":"D","amount":"$62.5 million","upfrontCash":"Undisclosed","newsHeadline":"Prilenia Therapeutics Raises $62.5M to Fund Late Stage Trials In HD and ALS","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"},{"company":"Prilenia therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia Enrolls First Patients Into its PROOF-HD Phase 3 Clinical Trial for Huntington\u2019s Disease in the United States","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"},{"company":"Prilenia therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia Enrolls First Subject in Europe in its PROOF-HD Phase 3 Clinical Trial for Huntington\u2019s Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"},{"company":"Prilenia therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia\u2019s Phase 3 Huntington\u2019s Disease Clinical Trial Achieves 50% Enrollment","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"},{"company":"Prilenia therapeutics","sponsor":"Sands Capital","pharmaFlowCategory":"D","amount":"$43.0 million","upfrontCash":"Undisclosed","newsHeadline":"Prilenia Closes Oversubscribed $43 Million in Series B Financing Round","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"},{"company":"Prilenia therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia Receives Fast Track Designation for Pridopidine for the Treatment of Huntington\u2019s Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Prilenia therapeutics"}]
Details:
Fast Track accelerate the registration process for pridopidine by providing the ability to file a rolling NDA and qualify for priority review, and administered orally acts as a highly selective and potent Sigma-1 Receptor agonist is for 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:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 17, 2021
Details:
The proceeds will be used to prepare for potential registration and commercialization of its lead drug candidate, pridopidine, for patients with Huntington’s Disease (HD) and Amyotrophic Lateral Sclerosis (ALS).
Lead Product(s):
Pridopidine
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Sands Capital
Deal Size: $43.0 million
Upfront Cash: Undisclosed
Deal Type: Series B Financing
November 03, 2021
Details:
Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties.
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 Group
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 11, 2021
Details:
The trial is investigating Prilenia’s lead candidate, pridopidine, for treatment of Huntington’s Disease. The study reached 25% in May 2021 and enrolled a further 25% in only six weeks, with now over 240 registered early-stage HD patients.
Lead Product(s):
Pridopidine
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 08, 2021
Details:
PRX–102 is currently being studied in the pivotal Phase III BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX–102 for the proposed treatment of 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
June 02, 2021
Details:
Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch.
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
February 10, 2021
Details:
The study is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of pridopidine 45 mg bid in patients with early-stage HD. PROOF-HD, a Phase 3 clinical trial in Huntington’s Disease (HD), is currently recruiting in Europe.
Lead Product(s):
Pridopidine
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 28, 2021
Details:
Pridopidine Outcome On Function in Huntington’s Disease (PROOF-HD) is a randomized, double-blind, placebo-controlled, phase 3 study evaluating the efficacy and safety of pridopidine 45mg bid in patients with early stage HD.
Lead Product(s):
Pridopidine
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
October 27, 2020
Details:
Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.
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
October 02, 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).
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
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