078 – FDA Approves Rhythm’s Setmelanotide! Anavex’s MAJOR Upcoming Rare Disease Readout

Rhythm Pharmaceuticals gets FDA approval for Setmelanotide (IMCIVREE) for Chronic Weight Management in Patients with Obesity due to POMC, PCSK1 or LEPR Deficiency (Age 6 and older). The management team also gave pricing information, indicating $330/mg and blended pricing estimate of $290-300K/patient/year. The stock rose about 21% on this news and I discuss the implications and future catalysts. Anavex’s ANAVEX2-73 (Blarcamesine) is being investigated for Alzheimer’s Disease, Parkinson’s Disease and Rett Syndrome. I go through the latest data and catalysts that are approaching for the company. I also touch on $HEPA’s latest press releases.

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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

 

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

 
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