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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 August 31, 2020
Details:
Top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.
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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 July 31, 2020
Details:
Analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in Triglyceride levels between screening and the time of patient randomization, which Acasti refers to as “Pre-randomization Triglyceride Normalization.
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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.
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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).
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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.
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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.
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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.
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Lead Product(s): Nerinetide
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Peptide
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
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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.
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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.
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