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

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 […]

AnaptysBio Phase 2a data breakdown and Biotech portfolio reveal!

-AnaptysBio shows positive phase 2a data from their peanut allergy study with ANB020 https://ir.anaptysbio.com/news-releases/news-release-details/anaptysbio-announces-positive-top-line-proof-concept-data-anb020 -Check out the PRACTALL guidelines for Oral Food Challenges Click to access Standardizing_DBPCFC_PRACTALL_2012.pdf -I’m not taking a position because with such a small sample size, and convoluted inclusion criteria, I need to see more data

DBVT fails to achieve 95% lower bound confidence interval in PEPITES

Good news and bad news. The bad: DBVT failed to achieve their primary endpoint. They saw a 21.7% improved response rate with a p-value < 0.00001 but their 95% confidence interval (CI) was 12.4%-29.8%. They needed to reach 15% on the lower bound of the confidence interval, and they were just below that. CIs provide […]

Going Nuts for Oral Immunotherapy – AIMT

Peanut allergy is reported to affect ~3 million Americans and there are approximately 210,000 emergency department visits attributed to food anaphylaxis in the USA per year (Sicherer SH, 2010, Clark S, 2013). Given that the only treatment for accidental ingestion of allergens is intramuscular epinephrine, companies have sought other ways to help patients with peanut […]