067 – Intercept Pharma’s Ocaliva Fails to get Approval in NASH while FGFs Compete for Best in Class

After delays in scheduling their advisory committee meeting, the FDA finally sends Intercept Pharma ($ICPT) a Complete Response Letter. In the letter, the FDA says that the benefits of Ocaliva shown via surrogate histopathologic endpoints do not sufficiently outweight the risks to support accelerated approval. Intercept will likely need to collect outcomes data to finally […]

032 – GILD Fails Phase 3 in NASH!

On this episode, I talk about results from the Gilead Phase 3 NASH trial that announced no improvement in patients treated with Selonsertib (ASK1 inhibitor). I also talk about the DBVT BLA resubmission and a hot hot Q319 trading idea on CBIO. Relevant links: https://www.gilead.com/news-and-press/press-room/press-releases https://www.dbv-technologies.com/investor-relations/press-releases/ http://ir.catalystbiosciences.com/news-releases *this is not investment advice, only my opinion […]

Viking Therapeutics and Madrigal Pharma go head-to-head

Viking Therapeutics reports their latest phase 2 data with their candidate thyroid hormone receptor β agonist. I compare both the madrigal and viking drug and discuss their potential in the NASH/NAFLD space.   *This is not investment advice*     Relevant links: http://ir.vikingtherapeutics.com/2018-09-18-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-Study-of-VK2809-in-Patients-with-Non-Alcoholic-Fatty-Liver-Disease-NAFLD-and-Elevated-LDL-Cholesterol https://clinicaltrials.gov/ct2/show/NCT02912260?term=madrigal&rank=4 https://clinicaltrials.gov/ct2/show/NCT02927184?term=viking+therapeutics&rank=1 Click to access Madrigal-Company-Overview-September-2018.FINAL_.20180903.pdf

Intercept Pharma’s Rocky Attempt at a NASH Drug

Non-viral liver disease is affecting western nations at an unprecedented rate. Much of this is attributable to poor diet, but given that lifestyle intervention doesn’t really fix the problem, there is a gigantic market opportunity. Non-alcoholic steato-hepatitis (NASH) affects ~5% of the population and the market in 2016 is estimated at around $800 million (Cassidy […]