Expert Financial Analysis and Reporting

Key Points: Comparison of three month data for CTL-019 in the JULIET trial with  Axi-Cel in ZUMA-1 indicates that safety and efficacy are remarkably comparable for the two products. At this point, there seems to be no differentiation between the two. Some analysts are strong propoents of Kite raised the issue that Novartis had manufacturing […]

The FDA has announced that there will be an AdCom meeting for Novartis’ CTL-019 for the treatment of pediatric r/r ALL on July 12. In my June 5th note, I wrote that Novartis was expecting an AdCom meeting for the pediatric r/r ALL indication. The PDUFA date is in late September but I think that […]

Northwest issued a press release announcing a presentation at ASCO today by the Company’s Chief Technical Officer, Dr. Marnix Bosch. The Company said that it will issue updates on: The Phase 3 trial of DCVax-L for newly diagnosed Glioblastoma multiforme (GBM) brain cancer, the Information Arm related to the phase 3 trial and the Company’s […]

Investment Conclusions: Cryoport: My recommended best way to invest in CAR-T launches (CYRX, Buy, $3.60) Kite Pharma: Seems priced for perfection (KITE, Underperform, $76.00) Novartis: Too big of a company to make an impact (NVS, No Opinion, $80.00) Be aware that June 14 could be a very important date. Novartis will present meaningful data on […]

Investment Thesis Windtree is facing the ultimate of binary events when it releases topline results in July for its critical phase 2b proof of concept trial of Aerosurf in premature babies with RDS syndrome. It is on track to run out of cash in July if it does not receive some type of cash infusion. […]

Investment Section  Overview This report is a follow-up to my April 12, 2017 report “Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)”. If you are unfamiliar with or need a refresher on Cryoport’s business, I would suggest that you read that report before continuing. By every measure […]

Key Points: The surprising and unconventional approval of Radicava (edaravone) shows how desperate the FDA is to expedite the approval of drugs for ALS; this was the first such approval in 20 years. This urgency should extend to getting tirasemtiv on the market if results are generally positive; topline results from the phase 3 VITALITY-ALS […]

��Overview of Report I am initiating coverage of Portola Pharmaceuticals with a Buy and a 2021 price target of $426.This is an extensive initial report on Portola Pharmaceuticals that is organized into five parts: Investment Overview for Portola is a summary of the key investment issues. An investor only needs to read this section in […]

Key Points: I continue to think that first ever CAR-T drug approval will be for Novartis’ CTL-019 in r/r pediatric ALL in September or October of 2017. Not long afterwards (weeks or a month or two), my best judgment is that CTL-019 and Kite’s Axi-Cel will be approved at the same time for the second […]

Cytokinetics is up $1.15 or 10% to $12.90 in a poor market environment. The only news is that the Company will be added to the S&P 600 small cap index. There is no fundamental news. I have seen before that when a stock is added to an index that the price jumps up meaningfully as […]