$PLX - Turtle progress (Today's announcement - read below)
CARMIEL, Israel, August 24, 2020 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE
American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development,
production and commercialization of recombinant therapeutic proteins produced by its
proprietary ProCellEx® plant cell-based protein expression system, today announced completion
of the treatment period of its Phase III BRIGHT clinical trial of pegunigalsidase alfa, or
PRX-102, for the proposed treatment of Fabry disease. The Company is currently working with
its service providers to complete the final monitoring visits necessary for final analysis of the
data; however, many sites are still impacted by ongoing local and state restrictions and
precautions due to the COVID-19 pandemic. The Company anticipates announcing top-line
results in the fourth quarter of 2020 once this process is completed.
“Completion of the BRIGHT study marks another important key milestone in our pursuit of an
alternative dose and regimen of pegunigalsidase alfa for the proposed treatment of Fabry
disease,” said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics.
“We eagerly anticipate announcement of top-line data, and are working towards the completion
of the final monitoring visits as quickly as possible. Our challenge now is to continue the work to
finalize these last details with the ongoing headwinds from COVID-19. I am very proud of our
team’s execution in completing the study and am confident in their ability to have the final data
as expeditiously as possible.”
Mr. Bashan continued, “The BRIGHT study is the second Phase III study of PRX-102 in Fabry
patients that we have completed as part of our comprehensive PRX-102 development program.
We announced positive results earlier this year from our Phase III BRIDGE clinical trial, and we
anticipate results from an interim analysis of our Phase III BALANCE clinical trial in the first
half of 2021. In addition, earlier this month, we announced the filing of the PRX-102 BLA by the
U.S. Food and Drug Administration with a PDUFA target date of January 27, 2021.”
Very Risky stock
Not for any advise
American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development,
production and commercialization of recombinant therapeutic proteins produced by its
proprietary ProCellEx® plant cell-based protein expression system, today announced completion
of the treatment period of its Phase III BRIGHT clinical trial of pegunigalsidase alfa, or
PRX-102, for the proposed treatment of Fabry disease. The Company is currently working with
its service providers to complete the final monitoring visits necessary for final analysis of the
data; however, many sites are still impacted by ongoing local and state restrictions and
precautions due to the COVID-19 pandemic. The Company anticipates announcing top-line
results in the fourth quarter of 2020 once this process is completed.
“Completion of the BRIGHT study marks another important key milestone in our pursuit of an
alternative dose and regimen of pegunigalsidase alfa for the proposed treatment of Fabry
disease,” said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics.
“We eagerly anticipate announcement of top-line data, and are working towards the completion
of the final monitoring visits as quickly as possible. Our challenge now is to continue the work to
finalize these last details with the ongoing headwinds from COVID-19. I am very proud of our
team’s execution in completing the study and am confident in their ability to have the final data
as expeditiously as possible.”
Mr. Bashan continued, “The BRIGHT study is the second Phase III study of PRX-102 in Fabry
patients that we have completed as part of our comprehensive PRX-102 development program.
We announced positive results earlier this year from our Phase III BRIDGE clinical trial, and we
anticipate results from an interim analysis of our Phase III BALANCE clinical trial in the first
half of 2021. In addition, earlier this month, we announced the filing of the PRX-102 BLA by the
U.S. Food and Drug Administration with a PDUFA target date of January 27, 2021.”
Very Risky stock
Not for any advise