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Expert Financial Analysis and Reporting

Post archive for ‘Smith On Stocks Blog’

Novartis Releases Three Month Interim Data for JULIET Trial of CTL-019 in r/r DLBCL

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 […]

FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Underperform, $80.25) and Cryoport (CYRX, Buy, $3.89)

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 Biotheraputics to Make Presentation at ASCO Today Monday June 5, 2017

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 […]

Key Investment Considerations Relating to Much Anticipated CAR-T Product Launches By Kite and Novartis Later This Year

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 […]

Cytokinetics: Comments on the Upside Move Today (CYTK, Buy, $12.90)

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 […]

SmithOnStocks Top Stock Picks for 2017, January 3, 2017

Purpose of this Report I last summarized my stock recommendations in a September 12, 2016 report. There has been little change in my thinking or my recommendations since then on most stocks in my universe, but I did issue a Buy on Bristol-Myers Squibb and a sell on Juno Therapeutics. You may want to revisit […]

SmithOnStocks Investment Recommendations Summarized; September 12, 2016

PURPOSE OF REPORT Biotechnology investing is characterized by long periods of steady, sometimes frightening declines followed by periods of euphoria. We have been in a deep bear market for emerging biotechnology stocks for over a year that has taken a heavy toll on stock prices. It looks like this may be starting to turn as […]

Bristol-Myers Squibb: Checkmate-026 Trial Fails to Reach Primary Endpoint (BMY, $62.85); A Buying Opportunity

Perspective Bristol-Myers Squibb Company announced today that Opdivo had failed to reach its primary endpoint of progression free survival in the CheckMate -026 trial in first line non-small cell lung cancer. This was an open-label, study that randomized 541 patients to receive either Opdivo as monotherapy or investigator’s choice of chemotherapy. Patients enrolled in the […]

A Non-Consensus, More Balanced Look at the CAR-T Development Efforts of Kite and Juno (Kite, $48.53: Juno, $30.42)

Definition of Key Terms Used in This Report Engineered Autologous T-cells (eACTS): These are T-cells that are removed from a patient and genetically engineered to increase their activity against cancer cells. They are then expanded into billions of clones that are reinfused into the patient where they continue to differentiate and attack cancer targets. Chimeric […]

Relypsa: Company Releases Veltassa Launch Metrics for May (RLYP, $18.14, Buy)

Investment Thesis Veltassa continues its slow but steady launch. The May results were in line with my projections and I think they were also generally in line with those of the Street. In the first year of a launch the new reality is that managed care sets up significant reimbursement hurdles. We are seeing this […]