Press Releases 2017

Press Releases 2017

  • Prometic’s Plasminogen (Ryplazim™) granted orphan drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF)

    Prometic’s Plasminogen (Ryplazim™) granted orphan drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF)

    In a gold-standard animal model proven to emulate pulmonary fibrosis in humans, Prometic’s Plasminogen (Ryplazim™) performed favorably compared to recently- approved IPF drugs to treat this condition.

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  • Prometic’s PBI-4050 receives Promising Innovative Medicine (PIM) designation from the UK MHRA in the treatment of IPF

    Prometic’s PBI-4050 receives Promising Innovative Medicine (PIM) designation from the UK MHRA in the treatment of IPF

    We are proud to have received a second PIM designation in the UK for PBI-4050, following the designation previously received for Alström syndrome.

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  • Pivotal data for Prometic’s intravenous Plasminogen replacement therapy to be presented at American Society for Hematology

    Pivotal data for Prometic’s intravenous Plasminogen replacement therapy to be presented at American Society for Hematology

    Prometic today announced that it will have two presentations at the 59th American Society of Hematology (ASH) Annual Meeting being held Dec. 9-12, 2017 in Atlanta.

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  • Prometic announces the closing of its USD $80 million (CAD $100 million) line of credit with structured Alpha LP, an affiliate of Thomvest

    Prometic announces the closing of its USD $80 million (CAD $100 million) line of credit with structured Alpha LP, an affiliate of Thomvest

    As partial consideration for establishing the Credit Facility, Prometic has granted Structured Alpha LP an initial 10 million warrants with an exercise price of CAD $1.70 per common share.

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  • Prometic reports positive interim clinical data from ongoing intravenous immunoglobulin (IVIG) pivotal phase 3 trial

    Prometic reports positive interim clinical data from ongoing intravenous immunoglobulin (IVIG) pivotal phase 3 trial

    Interim Clinical Data Shows Non Inferiority to Commercially-Approved Products for Primary Immunodeficiencies

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  • Prometic reports 2017 third quarter highlights and financial results

    Prometic reports 2017 third quarter highlights and financial results

    Both our plasma-derived and small molecules lead clinical programs continue to progress as planned throughout advanced stages of the regulatory approval pathway.

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  • Prometic to report its third quarter 2017 financial results and to hold conference call webcast

    Prometic to report its third quarter 2017 financial results and to hold conference call webcast

    Prometic announced that it will report its financial results for the third quarter ended September 30, 2017 on Monday November 13, 2017 after market close.

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  • Prometic receives clearance from the Swedish Medical Products Agency to initiate plasminogen diabetic foot ulcer phase 2 clinical trial

    Prometic receives clearance from the Swedish Medical Products Agency to initiate plasminogen diabetic foot ulcer phase 2 clinical trial

    The Phase 2 clinical trial is a prospective, dose escalation study of the safety, feasibility and initial efficacy of subcutaneous plasminogen for the treatment of DFU in 20 adult subjects.

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  • Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis (IPF)

    Prometic receives fast track designation for PBI-4050 in development for idiopathic pulmonary fibrosis (IPF)

    The Fast Track designation follows the FDA’s recent approval of Prometic’s Investigational New Drug (IND) application and design of the pivotal Phase 2/3 clinical trial in patients with IPF.

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  • Prometic enters into binding letter of intent to secure USD $80 million (CAD $100 million) line of credit from structured Alpha LP

    Prometic enters into binding letter of intent to secure USD $80 million (CAD $100 million) line of credit from structured Alpha LP

    The transaction will bridge expected plasminogen (RyplazimTM) revenues as well as other asset monetization events.

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  • Prometic presents PBI-4050 and PBI-4547 in vivo data at american association for the study of liver diseases (AASLD) meeting

    Prometic presents PBI-4050 and PBI-4547 in vivo data at american association for the study of liver diseases (AASLD) meeting

    We are excited by the implications of our data and the promise of our candidates PBI-4050 and PBI-4547 for the treatment and prevention of liver diseases,

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  • Prometic receives priority review status from Health Canada for Plasminogen (Ryplazim™)

    Prometic receives priority review status from Health Canada for Plasminogen (Ryplazim™)

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  • Prometic announces FDA acceptance of its biologics license application for Plasminogen (Ryplazim™)

    Prometic announces FDA acceptance of its biologics license application for Plasminogen (Ryplazim™)

    The acceptance of our BLA filing and setting of the PDUFA date by the FDA is a significant milestone for Prometic”, said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic.

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  • Prometic receives FDA clearance of its IND to initiate pivotal PBI-4050 phase 2/3 trial in patients with Idiopathic Pulmonary Fibrosis

    Prometic receives FDA clearance of its IND to initiate pivotal PBI-4050 phase 2/3 trial in patients with Idiopathic Pulmonary Fibrosis

    Prometic plans to supplement the IND with a protocol for a study of PBI-4050 monotherapy in IPF patients in October 2017

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  • Prometic reports positive clinical data from ongoing PBI-4050 study in Alström Syndrome patients

    Prometic reports positive clinical data from ongoing PBI-4050 study in Alström Syndrome patients

    Positive results support requests for meetings with both FDA and EMA to define the clinical-regulatory pathway for approval of PBI-4050 for the treatment of Alström syndrome.

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  • Prometic receives rare pediatric disease designation from U.S. FDA for its Plasminogen replacement therapy

    Prometic receives rare pediatric disease designation from U.S. FDA for its Plasminogen replacement therapy

    Prometic today announced that the U.S Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to Prometic’s Ryplazim, a plasminogen replacement therapy.

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  • Prometic reports 2017 second quarter highlights and financial results

    Prometic reports 2017 second quarter highlights and financial results

    Our second quarter 2017 financial results are in line with our expectations and last few quarters. We have and will continue to concentrate our efforts and resources on lower-risk clinical programs.

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  • Prometic and Shenzhen Royal Asset Management close transaction for joint venture and licensing rights to PBI-4050, PBI-4547 and PBI-4425

    Prometic and Shenzhen Royal Asset Management close transaction for joint venture and licensing rights to PBI-4050, PBI-4547 and PBI-4425

    Prometic today announced that it has executed definitive agreements in relation to the previously announced joint venture with affiliates of Shenzhen Royal Asset Management Co., Ltd. (SRAM).

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  • Prometic to report its second quarter 2017 financial results and to hold conference call webcast

    Prometic to report its second quarter 2017 financial results and to hold conference call webcast

    Prometic today announced that it will report its financial results for the second quarter ended June 30, 2017 on Monday August 14, 2017 after market close.

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  • Prometic announces positive long term clinical data on Ryplazim™ in Plasminogen congenital deficiency and provides regulatory update

    Prometic announces positive long term clinical data on Ryplazim™ in Plasminogen congenital deficiency and provides regulatory update

    Ryplazim™ (Plasminogen IV) long-term treatment shown to prevent recurrence of lesions at 48 weeks and maintains the same safety, tolerability profile without any serious adverse events at 48 weeks.

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