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Post archive for ‘LinkedIn’

Antares Pharma: My Hypothesis on Issues that Resulted in the CRL for Xyosted and Potential Timing of Approval (ATRS. Buy, $1.63)

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 […]

Portola: Management Guides to a Highly Probable US Launch of Bevyexxa in the December to February Timeframe (PTLA, Buy, $50.52)

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. […]

Cryoport: This Unique Company is Poised for Explosive Sales Growth; Price Weakness is a Buying Opportunity (CYRX, Buy, $6.68)

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 […]

Cytokinetics: Even if Tirasemtiv Were to Fail in Vitality-ALS. There is Great Long term Stock Potential (CYTK, $14.25, Buy)

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 […]

Antares: Approval of Xyosted is a Matter of When, Not If (ATRS, $2.12, Buy)

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 […]

Antares Pharma: FDA Action to not Approve Xyosted on its October 20, 2017 PDUFA Date is Perplexing (ATRS, Buy, $2.23)

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 […]

Repligen: More Detailed Analysis on GE Decision to Manufacture Protein A

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 […]

Update on Currently Recommended Stocks of SmithOnStocks.com

Report Overview I periodically update my recommendations and that is the objective of this report. I also spend some time on my analytical approach and investment philosophy. If your investment style is frequent trading, you should not waste your time reading this report. I have four Buy recommendations for stocks that have very significant near […]

Portola: Reiterating Buy and Refuting Recent Negative Blog by Adam F-stein (PTLA, Buy, $54.12)

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 […]

Northwest Biotherapeutics: Thoughts on Why the Phase 3 Trial of DCVax-L is Ongoing (NWBO, BUY, $0.17)

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 […]