Expert Financial Analysis and Reporting

Investment Thesis Xyosted is viewed by investors as the most important product in Antares” broad pipeline. In anticipation of approval on the PDUFA date of October 20, 2017 the stock price reached a high of $3.96 on October 10. Unexpectedly, Antares announced on October 11 that the FDA had identified deficiencies that prevented going forward […]

Perspective on Stock Price Behavior I began coverage of Portola with a Buy in a May 4, 2017 report at a price of $40.05. The basis for my recommendation was that PTLA had extremely impressive prospects based on the pending approvals in the US and Europe of two (not one) blockbuster products: Bevyexxa and AndexXa. […]

Investment Thesis By my analysis, Cryoport and its stock are coiled like a spring for future strong performance. My model is projecting over 50% per annum sales growth for the period 2017 to 2020 with sales estimated to increase from $12.1 million in 2017 to $41.8 million in 2020. The revenue mix is now shifting […]

Critical VITALITY-ALS Data Is Imminent During the 3Q conference call, Cytokinetics said that the still unknown results of the VITALITY-ALS trial of tirasemtiv in ALS have been accepted for presentation at the International Symposium on ALS/MND on December 8th at 4:20 p.m. in Boston; the presenter will be the lead investigator on the trial, Dr. Jeremy […]

The Issue Antares received a complete response letter for Xyosted that did not cite any questions relating to efficacy, manufacturing, quality control or the device used to deliver testosterone. Surprisingly, the FDA raised concerns that Xyosted could cause a clinically meaningful increase in blood pressure and might also be linked to depression and suicidality. Let […]

Overview Investors have had high confidence that Xyosted would be approved by the FDA on its October 20, 2017 PDUFA date. A press release and 8-K from Antares published on October 12 shattered this expectation. Antares’ stock promptly dropped 38% from $3.73 to $2.32 after the Company alerted investors to an issue with the Xyosted […]

Overview GE Healthcare, announced plans to launch a new chromatography resin in the first half of 2018 which will not use Repligen as the manufacturer of the associated protein A ligand. This news led to a 14% decrease in stock price from $43.22 at the close on September 25 to a closing price of $36.98 […]

Introduction Adam F-stein wrote an article on Portola on September 19, 2017 with the headline “Commercial launch of Portola’s new blood thinner could be threatened by new clinical guidelines”. This caused a 9% drop from the closing price of $56.57 of the prior day to $52.02 at the close on September 19. The analysis in […]

Overview The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS events (mPFS is a primary endpoint) and has probably surpassed 233 OS events (mOS is an independent co-primary endpoint). Reaching either or both of these events is not an automatic stopping point for the […]

The stoppage at an interim analysis of Bristol-Myers Squibb’s’ CHECKMATE-214 trial provides meaningful information into assessing the potential fro success of Northwest Biotherapeutics’ phase 3, DCVax-L trial. CHECKMATE-214 compared a combination the immunotherapy drugs Opdivo and Yervoy to Sutent (standard of care) in previously untreated, advanced or metastatic renal cell carcinoma (RCC). The trial was […]