Expert Financial Analysis and Reporting

Key Points of the GALACIC-HF Trial Cytokinetics declined sharply after it announced topline results in the huge 8,500 patient phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure. The study successfully reached the primary endpoint of time to cardiovascular death or first heart failure event with a p-value of 0.025 and a hazard […]

Cryoport’s stock has been on a roller coaster ride over the past ten days as shown in daily closing prices below: November 6 $45.69 November 12 $60.31 November 13 $59.00 November 16, current $51.86 I think that this price action centers around the market’s perception of the degree of involvement that Cryoport will have in […]

Key Investment Points I continue to be very bullish on the long term outlook for Cryoport. Listed below are some of the key points that investors should focus on. In past reports, I have emphasized that Cryoport sales stemming from support of commercial products was key to my projections for rapid sales growth. Almost all […]

There has been frenetic trading in Northwest Biotherapeutics stock as investors await the release of topline data from the DCVax-L phase 3 trial followed by the release of the full data set. There was speculation that the data could be presented at the Society for Immunotherapy of Cancer (SITC) in a poster session on either […]

Investment Opinion Data presented at the upcoming American Heart Association meeting on the phase 3 GALACTIC-HG trial on omecamtiv mecarbil could cause a sharp swing in the stock. The data could make investors more positive on the commercial potential of omecamtiv mecarbil in which case we could see a sharp upward move. Also possible is […]

Overview Northwest Biotherapeutics stock was on fire yesterday as the price increased 35% to $1.12. The strength appears to be  attributable to two posts on the investor website iHub. Thoughts on First Post The first post was as follows: “In the EU Clinical Trial register, it shows that the primary endpoint for the DCVax-L trial […]

Cytokinetics reported that the results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (HR: […]

Bristol-Myers Squibb has announced that it will acquire MyoKardia for $13.1 billion in cash and this has important implications for Cytokinetics. These companies have technologies that activate or inhibit muscle activation. To my knowledge they are the only two companies that have products in clinical development based on this technology. Interestingly, MyoKardia acquired technology from […]

Purpose of Note This note comments on two news events for Cryoport. The Company reported that it has completed the acquisitions of CRYOPRD and MVE Biological Systems as of October 1. This was somewhat faster than I expected. The stock  also was impacted by the news that Mesoblast’s Ryoncil had received a Complete Response Letter […]

Sales Projections for Xyosted Xyosted just completed its sixth full quarter of sales since its launch in 4Q, 2018. Almost all product launches are difficult in this managed care environment. It often takes a year or so to get reimbursement issues partially resolved. Just as Xyosted got through this, the launch ran smack into the […]