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 […]

IONS/AKCA receive thumbs down on Waylivra for FCS

“We are extremely disappointed with the FDA’s decision”, writes the Ionis Pharma press release in describing the Complete Response Letter (CRL) they received regarding their latest medicine, WAYLIVRA. They continue, “we feel strongly that WAYLIVRA demonstrates a favorable benefit/risk profile in people with FCS as was reflected in the positive outcome from our Advisory Committee […]