Ryplazim (Plasminogen)

Liminal BioSciences Announces Resubmission of Biologics License Application to U.S. Food and Drug Administration for Ryplazim® (plasminogen)

Liminal, through its U.S. subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the Biologics License Application (BLA) for Ryplazim® (plasminogen) (Ryplazim®) with the U.S. FDA

Prometic presents new PBI-4050 and Ryplazim (plasminogen) data on lung fibrosis at the 2019 ATS conference

Prometic today announced the presentation of three scientific posters on the Company’s lead small molecule and plasma-derived drug product candidates, respectively PBI-4050 and Ryplazim™.

Prometic reports its 2019 first quarter financial results

We made excellent progress during the quarter towards completing the necessary development work to permit re-filing of our Ryplazim™ (plasminogen) (“RyplazimTM ”) BLA before the end of 2019

Prometic announces second annual plasminogen deficiency awareness week

This initiative, sponsored by Prometic, aims to raise awareness and improve understanding of this rare disease and its effects. Plasminogen Deficiency Awareness Week is a free 4-day online event

Prometic announces positive feedback from FDA type-c meeting on Ryplazim (plasminogen) BLA

Implementation plan for additional analytical assays and in-process controls confirmed and PLI finalizing process performance qualification (PPQ) protocol in order to proceed with the manufacturing

Prometic reports second quarter 2018 financial results and highlights

Prometic has advanced multiple initiatives aimed at extending cash runway, including ongoing partnering discussions related to both PBI-4050 and RyplazimTM (plasminogen).

Prometic reports its Q4-2017 and annual 2017 financial results and provides update on activities

Lead drug candidates PBI-4050 and Ryplazim™ (plasminogen) continue to deliver consistent and positive clinical activity and tolerability data

Prometic announces realignment of its clinical program priorities for 2018

RyplazimTM (plasminogen) is the first biopharmaceutical expected to be launched commercially pending the review of its BLA

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.

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.

Prometic reports third quarter 2016 highlights and financial results

Plasminogen pivotal clinical trial results performed at 100% response rate meeting primary and secondary end points in plasminogen deficient patients

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.

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.

Prometic receives priority review status from Health Canada 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.

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.

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.

Prometic presents new data on PBI-4050 and Plasminogen at the American Thoracic Society’s 2017 international conference

Prometic presented new data at the 2017 American Thoracic Society (ATS) International Conference in Washington, D.C.

Prometic to present new data on how plasminogen reduces acute lung injury at the American Thoracic Society’s 2017 international conference

Prometic announced today that it will be presenting new data at the 2017 American Thoracic Society International Conference in Washington, D.C.showing the benefits of plasminogen in lung injury.