Liminal BioSciences Commences Collection of Convalescent Plasma from COVID-19 Recovered Donors
Recent published studies have indicated immune globulin and hyperimmune globulin therapy to have the potential to be one of the treatment options for patients with COVID-19. We are proud to be collecting COVID-19 convalescent plasma to be potentially used in the manufacture of hyperimmune immunoglobulins by third parties and be a part of this historic effort which aims to accelerate a reliable, scalable and sustainable option for patients suffering from the impact of COVID-19.
www.prnewswire.com/n...onors-301086358.html
Liminal BioSciences (LMNL +105.1%) expects to re-submit biologics licensing application (BLA) with the FDA for its lead plasma-derived Ryplazim (plasminogen) for congenital plasminogen deficiency, during Q3.
The company also anticipates to commence multiple ascending dose Phase 1 study of its lead small molecule product candidate fezagepras (PBI-4050) in second half of the year.
In March 2018, the company received FDA Complete Response Letter BLA for Ryplazim, and identified the need for number of changes in the Chemistry Manufacturing and Controls section.
In October 2018, announced positive feedback from FDA Type-C meeting on Ryplazim BLA.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood, and is vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
seekingalpha.com/new...g-catalysts-for-2020
Liminal BioSciences Provides Guidance Update on Certain Expected Key Milestones For 2020
we are continuing to execute and move our business forward, and remain committed to providing further updates on certain key expected milestones, as appropriate.
We now expect the following timing for two important priorities of the Company for 2020:
The re-submission of our biologics licensing application (BLA) with the US Food and Drug Administration (FDA) for Ryplazim® (plasminogen) for the treatment of congenital plasminogen deficiency is anticipated to be filed in the third quarter of 2020; and
Our multiple ascending dose (MAD) Phase 1 clinical study of fezagepras is expected to be initiated in the second half of 2020."
www.prnewswire.com/n...-2020-301086354.html
Recent published studies have indicated immune globulin and hyperimmune globulin therapy to have the potential to be one of the treatment options for patients with COVID-19. We are proud to be collecting COVID-19 convalescent plasma to be potentially used in the manufacture of hyperimmune immunoglobulins by third parties and be a part of this historic effort which aims to accelerate a reliable, scalable and sustainable option for patients suffering from the impact of COVID-19.
www.prnewswire.com/n...onors-301086358.html
Liminal BioSciences (LMNL +105.1%) expects to re-submit biologics licensing application (BLA) with the FDA for its lead plasma-derived Ryplazim (plasminogen) for congenital plasminogen deficiency, during Q3.
The company also anticipates to commence multiple ascending dose Phase 1 study of its lead small molecule product candidate fezagepras (PBI-4050) in second half of the year.
In March 2018, the company received FDA Complete Response Letter BLA for Ryplazim, and identified the need for number of changes in the Chemistry Manufacturing and Controls section.
In October 2018, announced positive feedback from FDA Type-C meeting on Ryplazim BLA.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood, and is vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
seekingalpha.com/new...g-catalysts-for-2020
Liminal BioSciences Provides Guidance Update on Certain Expected Key Milestones For 2020
we are continuing to execute and move our business forward, and remain committed to providing further updates on certain key expected milestones, as appropriate.
We now expect the following timing for two important priorities of the Company for 2020:
The re-submission of our biologics licensing application (BLA) with the US Food and Drug Administration (FDA) for Ryplazim® (plasminogen) for the treatment of congenital plasminogen deficiency is anticipated to be filed in the third quarter of 2020; and
Our multiple ascending dose (MAD) Phase 1 clinical study of fezagepras is expected to be initiated in the second half of 2020."
www.prnewswire.com/n...-2020-301086354.html