|Clinical and Regulatory|
|Event Type:||NDA Submission|
This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
|Disease and Treatment|
|Treatment Name:||QuickShot Testosterone|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Antares Pharma|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
ANALYSIS OF 26 WEEK SAFETY DATA FROM STUDY QST-15-005 COMPLETED, NDA SUBMISSION REMAINS ON TRACK FOR FOURTH QUARTER 2016
EWING, NJ, September 22, 2016 -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.