Expert Financial Analysis and Reporting

Report Highlights The pending approval of Novartis’ Car-T drug tisagenlecleucel is the beginning of a new era of drugs based on manipulation of genes, most commonly referred to as gene therapy. This promises to be a new dynamic to biopharma drug development that will be a strong (the major?) driver of industry revenues for the […]

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 […]

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 […]

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 […]

Key Points: Novartis will almost certainly gain approval for CTL-019 in r/r pediatric ALL early in 4Q, 2017. This would represent the first ever approval for a CAR-T product. Kite says that it will receive approval for Axi-Cel ((axicabtagene ciloleucel)) in r/r DLBCL and launch in the US in 2017 and will have first mover […]

Report Preface In the event that you are unfamiliar with acronyms used widely in this report such as CAR-T, DLBCL, TFL, ORR, CR etc. I would suggest that before going further that you click on this link for definitions. I often put what I consider to be key points, the investment opinion and target price at the […]

Introduction to Report I was closely watching the Amercian Society of Hematology (ASH) meeting held during December 3 to 6 for any meaningful new data on the CAR-T products: Kite’s KTE-C19, Juno’s JCAR-015 and JCAR-017 and Novartis’ CTL-019. There wasn’t anything really earthshaking that came out of ASH, but there were a few tidbits of […]

Key Investment Conclusions I believe that Juno will cease development of JCAR-015 and turn to JCAR-017 as its lead CAR-T product. I estimate that this will result in Juno dropping two years behind Kite and Novartis in the race to commercialize CAR-T therapy for the crucial r/r DLBCL market. I believe that this late entry will […]

Key Points; The most important data point between now and yearend 2016 is release of data from ZUMA-1 that shows whether the CR rate for KTE-C19 in r/r DLBCL remains unchanged at 33% over time. This is the expectation of key analysts and management. If it comes in meaningfully below that rate, the stock could […]