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 get FDA support but this will add significant time before approval.

Meanwhile, NGM Biotherapeutics ($NGM) and Akero ($AKRO) are two NASH companies commercializing their respective FGF molecules for the treatment of NASH. Akero recently released biopsy data from their Phase 2a study showing a strong effect of Efruxifermin in NASH. I talk about how this might be a good opportunity to take a position in 89 Bio, who has a related FGF21 drug.

If you want to help the show, you can donate here: https://tips.pinecast.com/jar/breaking-biotech You can also open an account at Tastyworks using my referral code: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ

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Send me an email matthewlepoire@gmail.com

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

 

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 around. So, if you’re an audio-only listener and hear something that doesn’t sound right, double check the video version, which corrects the mistakes via captions or has it written properly even though I say it wrong (i.e. I say 3E16 when 3E13 is clearly written on the slide).

Thanks to everyone for listening and do your own due diligence if you are considering investing, this is not a substitute for investment advice.

http://www.breakingbiotech.com
Follow me on twitter @matthewlepoire

 

037 – Sangamo Bounces Back! Viking’s Backup Drug

In this video, I go through Sangamo’s updated data with their Hemophilia A and Beta-Thalassemia treatments. I also talk about Viking Therapeutics’ VK5211, a potent selective androgen receptor modulator.

Follow me @matthewlepoire

*This is not investment advice*

http://www.breakingbiotech.com

#breakingbiotech #SGMO #VKTX

 

033 – ICPT Takes the Lead in NASH

In today’s episode, I breakdown the ICPT NASH results, followed up by a quick take on SAGE and the latest buyout rumors.

*this is not investment advice*

Relevant links:
http://ir.interceptpharma.com/news-releases/news-release-details/intercept-announces-positive-topline-results-pivotal-phase-3
https://www.sagerx.com/

http://www.breakingbiotech.com

 

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 and ideas*

http://www.breakingbiotech.com

#biotech #breakingbiotech #nash

 

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

 
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