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 […]
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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 […]
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 […]
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 2:44TGTX 4:29SAVA 6:27SRNE 11:27TRIL/MRKR 15:15GNFT/CBAY 20:55 If you want to help the show, you can donate here: https://tips.pinecast.com/jar/breaking-biotechYou can also open an account at Tastyworks using my referral code here: https://start.tastyworks.com/#/login?referralCode=ZWQ77XG2PZ Follow me on […]
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 […]
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 […]
051 – Amarin Receives UNANIMOUS Recommendation from Advisory Committee
I’m back! Here are the companies I touch on in this video: Sarepta: 2:30Trevena: 4:08Viking: 5:40Regenxbio: 7:47Biogen: 12:35Amarin: 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 […]
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
