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 […]

043 – Sarepta keeps the gene therapy throne in DMD! ContraVir submits NASH IND!

Hey everybody, hope you’re all doing well! In this video, I talk about Pfizer’s DMD gene therapy update that indicates continued Sarepta hegemony in the space. I also talk about ContraVir and their NASH drug, CRV431. I must have drank too much coffee before recording because I made more than a couple errors this time […]

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