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Expert Financial Analysis and Reporting

Post archive for ‘LinkedIn’

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, Underperform, $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 […]

Cryoport: Initiating Coverage of this Highly Unique Health Care Company with a Buy (CYRX, Buy, $2.25)

Introduction I am recommending purchase of Cryoport, which has developed a first mover, business model for providing cold chain logistics for high value life science products requiring cryogenic temperatures during shipment. This is report is divided into four sections: Investment Thesis: The first 11 pages of this report summarize the reasons why I am recommending […]

Repligen: A Business Update and Reiteration of Buy (RGEN, Buy, $34.11)

Investment Overview and Thesis A Long Buy Recommendation of Mine I first recommended Repligen in an initiation report in December 2012. At the time and on many occasions since, I have described its business model as being one of the very best I have seen. On a macro-basis its business sail is driven by the […]

Cytokinetics: Insights into Corporate Collaborations, Tirasemtiv, CK-107 and Hospitalization Caused by Heart Failure (CYTK, Buy, $11.25)

Introduction I was just going though the most recently published slide deck of Cytokinetics and found some slides that I thought were an interesting way of conveying information on corporate collaborations, the clinical status of CK-107, tirasemtiv and the serious unmet medical need for treatment of patients hospitalized with heart failure. None of these are […]

Kite Pharma: Novartis and Kite File for Regulatory Approval of Their CAR-T Products; I Do Not Believe That KITE Has a Meaningful First Mover Advantage (KITE, Underperform, $82.19)

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 […]

Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)

Acronyms Used in this Report SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by treatment with radiation and the chemotherapy drug temozolomide PFS: Progression free survival is the time from which the surgery is performed until the tumor begins to regrow mPFS: The median time at which half of […]

Antares: Pipeline is Bursting with Late Stage Products (ATRS, $2.77, Buy)

Key Points: Antares has an impressive portfolio of seven new products that could lead to explosive growth over the next four years. I am projecting that revenues of five partnered products could increase from $17.0 million in 2016 to $142.0 million in 2021 (a nearly five fold increase) and that revenues from two wholly owned […]

Cytokinetics: A Look at the Clinical Trial Programs Underway (CYTK, Buy, $13.00)

The Investment Thesis Is Based on Three Drugs in Late Stage Development In partnership with Amgen, Cytokinetics has advanced omecamtiv mecarbil into phase 3 development for congestive heart failure; topline data is projected for January 2021. Without a partner, Cytokinetics has progressed tirasemtiv into a late phase 3 ALS trial; topline data is projected for […]