Expert Financial Analysis and Reporting

Key Points: Cytokinetics is likely to report results from the phase 3 VITALITY-ALS trial in early December 2017. I believe that this trial has a good chance of hitting the primary endpoint of sustained vital capacity (SVC) and gaining approval. The economic consequences for CYTK shareholders are enormous. In this report, I estimate a 2025 […]

Key Points: Amgen and Cytokinetics have begun enrolling the phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure (CHF). Topline data is not expected until January 2021. However, in the event of strong efficacy, the trial could potentially be halted at an interim look in 2020. Between now and then there will be […]

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 […]

Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for the phase 3 ADAPT trial of its cancer vaccine AGS-003 in combination with Sutent in metastatic renal cell carcinoma recommended that the trial should be discontinued. Following an interim analysis, the DMC concluded that […]

Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been raised due to some postings on message boards. Negative blogs have contended that NWBO has included the clinical data from 32 pseudo-progressors in the clinical data base of 331 patients enrolled in the phase […]

Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18 months. We may see topline data on the phase 3 trial by mid-summer or possibly in a late breaker paper at ASCO in May. Linda Liau, principal investigator on the phase 3 trial, is encouraged […]

Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]

Terms and Implications of This Deal Cytokinetics announced that it had concluded a deal to sell a portion of the future royalty stream on omecamtiv to Royalty Partners, perhaps the leading purveyor of this type of financial instrument. Omecamtiv is partnered with Amgen and recently entered the phase 3 GALACTIC HF trial which will enroll […]

Key Points: Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of AMAG, but has had only a modest effect on ATRS. I believe that this does not change the commercial opportunity for Makena SC over the next two to three years. This potentially could move the […]

The New Press Release Bristol-Myers Squibb’s stock declined from $55.49 at the close on Thursday January 19 to $49.23 at the close on Friday January 20. This was due to a terse press release on January 20th that read “Bristol-Myers Squibb Company announced today that it has decided not to pursue an accelerated regulatory pathway […]