Cardiology/Vascular Diseases | Phase III Developments | CANADA

DalCor Pharmaceuticals

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CANADA Canada

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DalCor Announces Dal-GenE Trial Continues with Final Data Expected in the First Half of 2021

Lead Product(s): Dalcetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

Details:

The independent dal-GenE Data and Safety Monitoring Board (DSMB) recommends the dal-GenE pivotal outcomes trial should continue as planned with no modifications. This is an important milestone for DalCor and for cardiovascular patients with the ADCY9 AA genotype.

Milestone Pharmaceuticals

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Milestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT

Lead Product(s): Etripamil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: MSP-2017

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 23, 2020

Details:

Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05).

Acasti Pharma

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Acasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package

Lead Product(s): Omega-3 phospholipid

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Capre

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 19, 2020

Details:

The FDA that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as contemplated in the original Statistical Analysis Plan, and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes.

Acasti Pharma

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Acasti Pharma Announces Submission of TRILOGY 1 Briefing Package to FDA

Lead Product(s): Omega-3 phospholipid

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2020

Details:

The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020 regarding review of the relevant TRILOGY 1 data and audit findings.

Milestone Pharmaceuticals

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Milestone Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial

Lead Product(s): Etripamil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 23, 2020

Details:

Etripamil (70mg) did not achieve its primary endpoint of time to conversion of SVT to sinus rhythm (SR) compared to placebo over the five hour period following study drug administration.

NoNO

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CANADA Canada

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NoNO Inc. Reports Groundbreaking Results from the Phase 3 ESCAPE-NA1 Study of the Peptide, Nerinetide, in Acute Ischemic Stroke

Lead Product(s): Nerinetide

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 20, 2020

Details:

The novel peptide nerinetide, without prior administration of alteplase, improved functional outcome, reduced mortality and reduced infarct volume among acute ischemic stroke patients

Acasti Pharma

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Acasti Pharma Provides Update on TRILOGY 1 and TRILOGY 2 Phase 3

Lead Product(s): Omega-3

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 10, 2020

Details:

Acasti Pharma plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020.

Resverlogix Corp

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Resverlogix Confirms a Significant Corporate Advancement Establishing Apabetalone as a Potential Blockbuster Combination Drug in High-risk D...

Lead Product(s): Apabetalone

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2020

Details:

BETonMACEresults show 57% hazard reduction in primary mace for patients on apabetalone and new oral anti-diabetic treatments.

Acasti Pharma

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Acasti Pharma Reports Topline Results for TRILOGY 1 Phase 3 Trial of CaPre

Lead Product(s): Omega-3 phospholipid

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2020

Details:

A phase 3 trial of Acasti Pharma’s omega-3 drug CaPre has missed its primary endpoint, denting its hopes of challenging Amarin’s Vascepa for the hypertriglyceridemia market.

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Find Drugs for Cardiology/Vascular Diseases in Phase III Clinical Development in CANADA

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DalCor Pharmaceuticals

DalCor Announces Dal-GenE Trial Continues with Final Data Expected in the First Half of 2021

Milestone Pharmaceuticals

Milestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT

Acasti Pharma

Acasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package

Acasti Pharma

Acasti Pharma Announces Submission of TRILOGY 1 Briefing Package to FDA

Milestone Pharmaceuticals

Milestone Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial

NoNO

NoNO Inc. Reports Groundbreaking Results from the Phase 3 ESCAPE-NA1 Study of the Peptide, Nerinetide, in Acute Ischemic Stroke

Acasti Pharma

Acasti Pharma Provides Update on TRILOGY 1 and TRILOGY 2 Phase 3

Resverlogix Corp

Resverlogix Confirms a Significant Corporate Advancement Establishing Apabetalone as a Potential Blockbuster Combination Drug in High-risk D...

Acasti Pharma

Acasti Pharma Reports Topline Results for TRILOGY 1 Phase 3 Trial of CaPre