-Trevena's morphine competitor, Oliceridine, just received negative news from the FDA Advisory Committee. The FDA PDUFA date is November 2nd, but they are likely to follow the adcom's decision -It also look like Trevena mislead investors by announcing they had successful meetings with the FDA, while the FDA claims they had many problems with the study-design proposed by TRVN including endpoints and statistical analyses. -Press releases from TRVN in the past say different than the adcom documents, which many firms are taking up as class action lawsuits...especially given TRVN's latest 8-K filing I do not have any position in the company and this is not investment advice. Follow me on twitter @matthewlepoire www.breakingbiotech.com Relevant links: http://www.trevena.com/news-details.php?id=211 https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622730.pdf http://www.trevena.com/news-details.php?id=212

Sarepta took a hit from their latest Micro-Dystrophin gene therapy trial update despite showing robust expression in all 4 patients, confirmed by protein analyses and behavioral improvements. In this video, I go through the details of muscular dystrophy, the current treatment options and how this new therapy could significantly improve patients outcomes. I have not taken a position and this is not investment advice. Follow me @matthewlepoire www.breakingbiotech.com Relevant links: https://www.sarepta.com/our-pipeline https://www.sec.gov/Archives/edgar/data/873303/000119312518292068/d616670dex992.htm

-Amarin's EPA medicine, Vascepa, recently showed a 25% relative risk reduction in newly announced data from the cardiovascular outcomes trial, REDUCE-IT. -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. this is not investment/trading advice Follow me @matthewlepoire www.breakingbiotech.com 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 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 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 in the blood/urine. The uGAG measurements are not the breakdown products but the actual targets of IDS, which are what is measured in the blood/urine. -Around 3:30 I talk about the expression of the transgene. The AAV will circulate and infect a variety of cells. The gene editing will take place after albumin promoter of the genome, which is only active in hepatocytes. Hepatocytes will be the only cell type to express the transgene, and the product will circulate in the blood to other tissues. This is not investment advice Relevant links: https://www.sangamo.com/ https://seekingalpha.com/article/4205472-depth-analysis-sbminus-913-early-clinical-readout-mps-ii https://seekingalpha.com/article/4205037-sangamo-work https://doi.org/10.1016/j.ymthe.2018.03.002 https://twitter.com/gcbioinv/status/1038424280047013888 https://www.ncbi.nlm.nih.gov/pubmed/23837440 Follow me @matthewlepoire See the blogpost at www.breakingbiotech.com

Ionis Pharma has brough antisense therapy to the clinic. Unfortunately, they recently received a complete response letter from the FDA regarding their latest medicine, Waylivra for the treatment of familial chylomicronemia syndrome. In this video, I talk about antisense therapy and the potential way forward for the company. For a complete writeup, check out the post here - Follow me on twitter @matthewlepoire this is not investment advice Links: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM606857.pdf http://ir.ionispharma.com/news-releases/news-release-details/akcea-and-ionis-receive-complete-response-letter-waylivra-fda http://ir.ionispharma.com/static-files/7e19a292-b451-41ef-9e14-4449962c6464

-Esperion Therapeutics hopes to bring their LDL-c lowering drug, Bempedoic Acid, to the market -Their latest data shows a slight increase in patient deaths, which has pushed the stock lower, but I don't believe this to be meaningful -PCSK9 inhibitors are very expensive, and ESPR believes they can charge a lower price and attract a large number of patients -The FDA may require a large-scale cardiovascular outcomes trial that will delay full approval of BA -Follow me @matthewlepoire Relevant links: http://investor.esperion.com/static-files/88da95da-bb52-4e7e-a9dd-1d52e70f3a6b https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4719137/pdf/ahdb-08-483.pdf https://www.nature.com/news/the-fda-chief-must-not-be-a-proxy-for-industry-1.21661 This is not investment/trading advice

-Gilead loses 3 executives in the last 6 months, but that's not why I sold! -New research suggests that closed-loop insulin delivery-glucose monitoring keeps type 2 diabetics in range better than conventional therapy Follow me @matthewlepoire this is not investment advice

Today I go through various Q2 earnings reports and see where each company stands relative to its value. I spend most of my time talking about the drop in ONCE and whether or not it is an overreaction. this is not investment advice

Today I break down Alzheimer's disease and the latest Biogen Phase 2 trial results. This is not investment advice