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Post archive for ‘LinkedIn’

FDA Announces July 12 AdCom Meeting for CTL-019: Thoughts on How This Might Affect Investor Perceptions of Kite (KITE, Neutral, $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 […]

Windtree Therapeutics: Thinking About the Stock Price After Phase 2b Results for Aerosurf in RDS Are Released In July (WINT, $0.92)

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. […]

Cryoport: Observations on 1Q, 2017 Results (CYRX, Buy, $3.05)

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 […]

Cytokinetics: What Are the Implications for Tirasemtiv Following the Approval of Radicava (Edaravone) for ALS? (CYTK, Buy, $15.40)

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 […]

Portola Pharmaceuticals: Initiating Coverage with a Buy (PTLA, $40.05)

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 […]

Thoughts on the Probable Launches of the First CAR-T Drugs; Cryoport is a Novel Way to Invest In This: Cryoport (CYRX, Buy, $2.36) and Kite (KITE, Neutral, $83.37)

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: 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 […]

Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)

AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance.  AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares. AMAG revealed that it will […]