Archive for October, 2017
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 […]