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

Follow me on twitter @matthewlepoire

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

 

065 – Are Iovance’s Buyout Hopes SHATTERED?? Karyopharm Moves to Expand Selinexor’s Label

Iovance (#IOVA) confirms a profound effect of LN-144 in metastatic melanoma with interim data from their 4th cohort. They also showed early data in NSCLC, which is an important indication for the company’s future. Karyopharm’s (#KPTI) Selinexor is approved for 5th line Multiple Myeloma and is currently being tested in other diseases. They have a number of upcoming catalysts that are likely to maintain the stocks value, and I discuss the details of my rough model for estimating value.

Warning: My ASCO updates are boring. Most posters/presentations were in line with abstracts provided weeks ago. Also, I say “661” during the TRIL section, but I really mean “621”.

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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ

Follow me on twitter @matthewlepoire

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.

 

064 – Moderna Presents LAUGHABLE Interim Vaccine Data. Verastem Shows Mixed Success in Solid Tumors

Moderna Tx announced their first data from MRNA-1273 as a vaccine for SARS-CoV-2. In this video, I breakdown the press release and talk about how they missed the mark with providing only descriptive information. I then talk about Verastem Oncology (#VSTM), a company looking to treat cancer. Their one approved asset, Copiktra, is indicated for some 3L Non-Hodgin Lymphomas. But, they are moving through Phase 1 with another combo asset (Defactinib + VS-6766), trying to treat a variety of solid tumors, especially non small cell lung cancer.

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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ

Follow me on twitter @matthewlepoire
Send me an email matthewlepoire@gmail.com
http://www.breakingbiotech.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.

 

063 – Biotech Updates (Including NASH follow up) STML TGTX SAVA SRNE TRIL MRKR GNFT CBAY

Hey everybody! In this video, I catch up on a variety of biotech companies. Timestamps for the respective company are below:
STML 2:44
TGTX 4:29
SAVA 6:27
SRNE 11:27
TRIL/MRKR 15:15
GNFT/CBAY 20:55

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 here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ

Follow me on twitter @matthewlepoire
Send me an email matthewlepoire@gmail.com
http://www.breakingbiotech.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.

 

058 – COVID-19 Escalates but Biotech Bright Spot in Trillium Therapeutics

The COVID-19 story escalates with worldwide cases hitting 100,000. In this episode of #BreakingBiotech, I talk about the concerns of the virus spreading unknowingly in the USA since the CDC has largely failed to provide the necessary resources. I also go into details about latest earnings report from Biogen (#BIIB) and breakdown an emerging immuno-oncology target (CD-47) with a focus on Trillium Therapeutics (#TRIL).

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

 

057 – Updating on TRVN, MRKR, BIIB and Institutional Buys

Hey everybody, in this episode I give updates on Trevena, Marker Therapeutics, and Biogen. I also touch on recent Alzheimer’s failures by Lilly and Roche. I wrap up the episode talking about some of the 13G filings from various hedge funds/advisors and what it could mean for our favorite biotechs.

Unfortunately, the video did not encode properly and I wasn’t able to fix it so we’re going audio-only. Check out the tweet from @pawcio2009 I refer to regarding institutional buys and sells here: https://twitter.com/pawcio2009/status/1228548473592655873

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

 

051 – Amarin Receives UNANIMOUS Recommendation from Advisory Committee

I’m back! Here are the companies I touch on in this video:

Sarepta: 2:30
Trevena: 4:08
Viking: 5:40
Regenxbio: 7:47
Biogen: 12:35
Amarin: 17:38

all of this is only opinion and nothing I have said should be taken as investment advice

http://www.breakingbiotech.com

 

049 – Is Odonate’s Hype Overblown?

Today, I talk breast cancer and how Odonate’s oral Taxane (Tesataxel) could garner the attention of doctor’s looking to alleviate the burden of IV chemotherapy infusion in their patients. I discuss the latest macro news, biotech news, and compare previous Taxane revenue to see if my model is reasonable.

This is not investment advice, but for entertainment purposes. I am not liable for any losses you generate from trading.

 

048 – Advisory Committee votes YES on Aimmune’s Palforzia

In this video, I discuss the details of the advisory committee that recently occurred regarding Aimmune Therapeutics’ peanut allergy treatment, Palforzia (formerly AR101). The committee voted in support of approval and should pave the way for a positive PDUFA decision.

this is not investment advice

http://www.breakingbiotech.com

 

047 – Sarepta Receives CRL for Golodirsen! IOVA impresses in solid tumors.

In this video, I talk about Sarepta and their issues regarding the CRL received for Golodirsen. I also take a close look at Iovance Biotherapeutics and their tumor infiltrating lymphocyte cell therapy for cancer treatment.

this is not investment advice

http://www.breakingbiotech.com

 
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