077 – Advisory Committee Votes NO on Biogen’s Aducanumab! Rhythm Pharma’s Major Upcoming Catalysts

Rhythm Pharmaceuticals is tackling rare genetic obesity disorders with their MC4R agonist, Setmelanotide. They have 3 upcoming catalysts, the most important being the effect of the compound on a basket of high impact “loss of function” patients (POMC/LEPR-deficient heterozygotes, in particular). I go through all their catalysts in great detail along with a mock model.
Biogen’s Aducanumab was decidedly voted against in a recent FDA advisory committee with regards to the evidence provided in support of an effect in Alzheimer’s disease. The stock saw serious volatility after the FDA briefing documents were released, but has since subsided with a CRL likely being priced in. I also touch on $AXGT ($SIOX) and $ATNM.

If you want to help out the show (or join the discord), take a look at my patreon: https://www.patreon.com/breakingbiotech Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com http://www.breakingbiotech.com #breakingbiotech Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech

 

060 – Amarin Loses Vascepa Exclusivity in USA. Athersys Pivots to COVID-19.

The District Court of Nevada rules that Amarin’s Vascepa patents are invalid, but an appeal has already been filed! Axsome therapeutics fails their Phase 3 trial in treatment-resistant depression, but plans on moving forward with another trial. Finally, I talk about Athersys and their Multistem Cell Therapy for Acute Respiratory Distress Syndrome after receiving a “Highly Relevant” designation from the Biomedical Advanced Research and Development Authority (BARDA) of United States HHS.

For more details on the Amarin patent case, check out Zachary Silbersher’s blog here: https://www.markmanadvisors.com/blog/2020/3/31/can-amarin-win-on-appeal-in-the-vascepa-patent-litigation

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

 

053 – Amarin Raises Guidance on Vascepa Label Expansion. ASH Updates Impress!

Amarin finally receives label expansion for Vascepa, which can now be marketed to patients with Triglyceride levels of greater or equal to 150mg/dl and existing Cardiovascular Disease or Diabetes Mellitus plus two other risk factors for CVD. In this video, I go through what I think is the potential market for this drug and the company’s valuation. I also talk about a number of other companies that had updates at ASH2019 or around that time, including BLUE, FATE, DTIL, KOD, SRPT, SNY.

Follow me on twitter @matthewlepoire

Email me at matthewlepoire@gmail.com

Relevant sources:

  • Fan W. Diabetes. 2018:67(Suppl 1)
  • 2019 AHA Heart Disease and Stroke Statistics
  • Fan W. J Clin Lipidol. 2018:13(1)
  • Einarson TR. Cardio Diabetol. 2018 17(83)

Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt’s opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast.

 

050 – Acasti Pharma’s Novel Omega-3 Formulation Steps Up!

Hey everybody, we made it to #50! In this episode, I chat with Nathan Weinstein from Aegis Capital about Acasti Pharma. We discuss the omega-3 space and Acasti’s EPA/DHA formulation called CaPre. Acasti is seeking the approval of CaPre for the indication of severe hypertriglyceridemia and has two pivotal catalysts at the end of the year, which will be massive movers for the stock. Amarin’s upcoming catalysts are also likely to affect them. Check out the whole video for more details!

Relevant links:
https://www.acastipharma.com/en/investors/company-information/presentations
https://www.aegiscapcorp.com/service/nathan-weinstein/

this is not investment advice

 

046 – FDA Announces Last Minute Advisory Committee For Amarin’s Vascepa

Hey everyone! In this video, I discuss the relationship history between Amarin and the FDA regarding their EPA medication (Vascepa) for the lowering of triglycerides. I believe the difficulty #AMRN has had with the FDA in the past has made the market concerned about Vascepa’s future given recent announcement of an advisory committee meeting for label expansion of Vascepa. I also talk about Sarepta, Novartis and Gilead. Thanks for watching!

For my previous analysis of Amarin, check out #034.

*This is not investment advice. Please do your own due diligence before ever investing in equity markets.*

http://www.breakingbiotech.com
Great resource on Amarin’s approval issues with the FDA

 

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*

 

034 – FDA’s Gottlieb Resigns plus AMRN Breakdown

In this episode, I talk about the latest news in the biotech sector with details on my DCF model for Amarin and their fish oil pill, vascepa. I also talk about the limb-girdle data from Sarepta.

Hit the like and subscribe button!

*this is not investment advice*

http://www.breakingbiotech.com

 

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 primary endpoint, which evaluated cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina. In this video, I go through two critiques of the study:
1) Lack of mechanistic insight
2) Mineral oil use in the placebo group
I believe Vascepa is likely to get FDA approval for the indication of reducing cardiovascular disease in patients with over 150mg/dl Triglycerides on statin therapy.

This is not investment advice, do your own due diligence.

Relevant links:
https://investor.amarincorp.com/
https://www.nejm.org/doi/full/10.1056/NEJMoa1812792
https://www.nejm.org/doi/full/10.1056/NEJMe1814004

 

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

Click to access AMRN%20Investor%20Deck%20Sept%20Post%20R-IT%20v3.pdf


https://www.ncbi.nlm.nih.gov/pubmed/29935936

*this is not investment/trading advice*
Follow me @matthewlepoire

 
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