060 – Amarin Loses Vascepa Exclusivity in USA. Athersys Pivots to COVID-19.

The District Court of Nevada rules that Amarin’s Vascepa patents are invalid, but an appeal has already been filed! Axsome therapeutics fails their Phase 3 trial in treatment-resistant depression, but plans on moving forward with another trial. Finally, I talk about Athersys and their Multistem Cell Therapy for Acute Respiratory Distress Syndrome after receiving a […]

053 – Amarin Raises Guidance on Vascepa Label Expansion. ASH Updates Impress!

Amarin finally receives label expansion for Vascepa, which can now be marketed to patients with Triglyceride levels of greater or equal to 150mg/dl and existing Cardiovascular Disease or Diabetes Mellitus plus two other risk factors for CVD. In this video, I go through what I think is the potential market for this drug and the […]

050 – Acasti Pharma’s Novel Omega-3 Formulation Steps Up!

Hey everybody, we made it to #50! In this episode, I chat with Nathan Weinstein from Aegis Capital about Acasti Pharma. We discuss the omega-3 space and Acasti’s EPA/DHA formulation called CaPre. Acasti is seeking the approval of CaPre for the indication of severe hypertriglyceridemia and has two pivotal catalysts at the end of the […]

046 – FDA Announces Last Minute Advisory Committee For Amarin’s Vascepa

Hey everyone! In this video, I discuss the relationship history between Amarin and the FDA regarding their EPA medication (Vascepa) for the lowering of triglycerides. I believe the difficulty #AMRN has had with the FDA in the past has made the market concerned about Vascepa’s future given recent announcement of an advisory committee meeting for […]

041 – Is REGENXBIO a buy after Zolgensma approval?

Today, I talk about REGENXBIO and their in-house gene therapy candidates. Their most important asset in early clinical trials is RGX-314, indicated for wet AMD (and hopefuily Diabetic Retinopathy). This gene therapy could replace blockbuster drugs that treat millions patients, but is it a buy today? Follow me @matthewlepoire http://www.breakingbiotech.com *this is not investment advice*

027 – Amarin Sells Off Amid Positive Vascepa Data

Amarin recently published data from their REDUCE-IT cardiovascular outcomes trial. Their EPA medicine, Vascepa, showed a 25% relative risk reduction compared to placebo. EPA is an omega-3 fatty acid that previously showed a 19% relative risk reduction in cardiovascular outcomes in a Japanese study (JELIS, 2007). Amarin saw a hazard ratio of 0.75 in their […]

Amarin’s Vascepa Success

-Amarin’s EPA medicine called Vascepa recently showed a 25% relative risk reduction in newly announced data from a CardioVascular Outcomes Trial. -Today I breakdown the results and talk about how it compares to other CVOT data and whether Amarin is likely to rival companies with a LDL-c lowering drug pipelines. Relevant links: http://investor.amarincorp.com/node/15741/pdf Click to […]