Lead Product(s) : DM199
Therapeutic Area : Neurology
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
DiaMedica Therapeutics Announces Clinical Hold of its Phase 2/3 ReMEDy2 Clinical Trial for DM199
Details : Clinical Hold has placed on DM199, a recombinant form of human tissue KLK1, based on submission of three serious adverse event reports to the FDA related to clinically significant, transient hypotension (low blood pressure) occurring shortly after initia...
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 06, 2022
Lead Product(s) : DM199
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : In the study, 45 patients received placebo and 46 were treated with DM199. During the 90-day follow-up period, recurrent ischemic stroke occurred in 6 patients of the placebo arm versus none in the DM199 arm. Moreover, 4 of the recorded strokes in the pl...
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 08, 2021
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DM199
Therapeutic Area : Nephrology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DiaMedica's presentation include an abstract on REDUX Study: A Multicenter Study of DM199 in Chronic Kidney Disease Stage II or III” patients and an abstract on Kallikrein Protein (KLK1) Levels in Patients with Chronic Kidney Disease and Normal Kidney ...
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 05, 2021
Lead Product(s) : DM199
Therapeutic Area : Nephrology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DM199 is a recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1). DiaMedica plans to submit an investigational new drug (IND) application to the FDA for the phase 2/3 study in the first quarter of 2021.
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 09, 2021
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II/ Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DM199
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Guggenheim Securities, LLC
Deal Size : $20.0 million
Deal Type : Public Offering
DiaMedica Announces Closing of $23 Million Public Offering of Common Shares
Details : Net proceeds to be used in continuing clinical and product development activities, including the addition of a new cohort III to its REDUX study to be comprised of Type II diabetes mellitus patients with CKD, hypertension and albuminuria, and general cor...
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Undisclosed
August 06, 2020
Lead Product(s) : DM199
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Guggenheim Securities, LLC
Deal Size : $20.0 million
Deal Type : Public Offering
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : DM199 met primary safety and tolerability endpoints in ReMEDy study top-line data. There was also a demonstrated therapeutic effect in participants who received tissue plasminogen activator (tPA) prior to enrolment.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 13, 2020
Lead Product(s) : DM199
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : DM199
Therapeutic Area : Nephrology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalent to Support DiaMedica Trial Using GPEx Technology
Details : WI facility to support the trial using its GPEx cell line development technology. DiaMedica intends to initiate enrollment in the study in the next few weeks.
Brand Name : DM199
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 23, 2020
Lead Product(s) : DM199
Therapeutic Area : Nephrology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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