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 http://investor.amarincorp.com/system/files-encrypted/nasdaq_kms/assets/2018/09/27/10-23-58/AMRN%20Investor%20Deck%20Sept%20Post%20R-IT%20v3.pdf https://www.ncbi.nlm.nih.gov/pubmed/29935936 […]

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 https://www.madrigalpharma.com/wp-content/uploads/2018/09/Madrigal-Company-Overview-September-2018.FINAL_.20180903.pdf

Sangamo Therapeutics drops after SB-913 update

-Sangamo Therapeutics recently announced their Phase 1/2 data for the treatment of MPS II/Hunter Syndrome -The market reacted negatively to the news because of the uncertainty associated with unclear IDS activity and unclear metrics for successful approval by the FDA I misspoke a couple times: -Around 2:00 I say the breakdown products can be detected […]

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 […]

I was wrong about Zogenix! FDA updates guidelines for gene therapy.

Note: I meant to say that sub-1% factor activity is SEVERE hemophilia. Normal is from 50% to 150%. Today I talk again about Zogenix because I was wrong about Study 2 being priced in! Congrats to the ZGNX holders. I also talk about the new FDA guidelines on gene therapy for hemophilia and its implications […]