New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 24, 2014
09:03 EDTATRS, DCTHAntares Pharma announces resignation of CEO Wotton, names Hobbs as CEO
Antares Pharma (ATRS) announced the resignation of Paul K. Wotton, Ph.D. who informed the companys Board of Directors that he will assume the position of CEO of a development stage biotechnology company. Wotton also has resigned from the Antares Board of Directors. Antares Pharma also announced today the appointment of Eamonn P. Hobbs to the position of President and CEO of the company effective immediately. Hobbs joined the Antares Board of Directors in August 2009 and has over 30 years of experience in the pharmaceutical, medical device, and combination products industry, including the medical specialty fields of radiology, vascular surgery, interventional cardiology, oncology and gastroenterology. Hobbs was previously the President and CEO of Delcath Systems (DCTH).
News For ATRS;DCTH From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 16, 2015
10:20 EDTATRSAntares Pharma management to meet with JMP Securities
Subscribe for More Information
January 13, 2015
09:07 EDTATRSOn The Fly: Pre-market Movers
HIGHER: Apple (AAPL), up 1.4% after Credit Suisse upgraded Apple to Outperform and raised its iPhone volume estimates again... Best Buy (BBY), up 2.8% after being upgraded to Buy from Neutral at Goldman... SunPower (SPWR), up 2.6% after being upgraded to Outperform at Credit Suisse... Alcoa (AA), up 2% after Q4 results beat expectations. RISING AFTER GUIDANCE: Pharmacyclics (PCYC), up 17.5%... CTI BioPharma (CTIC), up 8.3%... Emulex (ELX), up 15.5%... ARIAD (ARIA), up 2.6%. LOWER: ChannelAdvisor (ECOM), down 42% following preliminary fourth quarter revenue guidance and after receiving multiple analyst downgrades... Antares Pharma (ATRS), down 7.7% after the FDA recommended that the company create a larger safety database for its clinical development program for QuickShot Testosterone.
07:08 EDTATRSAntares Pharma receives written recommendations from FDA on QuickShot
Antares Pharma announced that it has received written recommendations from the FDA related to its clinical development program for QuickShot Testosterone, or QS T. The recommendations received were in response to various clinical, Chemistry, Manufacturing and Controls and user study submissions made by the company through November 2014. The company believes that it has already factored many of the recommendations cited in the advice letter into the protocol of the ongoing phase 3 study and into the protocols for planned human use studies as a result of guidance provided by FDA at the May 2014 Type C meeting. Based on a single reported occurrence of hives in the companys phase 2 study, which the FDA characterized as an apparent allergic reaction, as well as the known safety experience with other parenteral testosterone products, the FDA is recommending that the company create a larger safety database, including approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. The company does not believe that the adverse event of hives reported in the phase 2 study was related to study drug. Based on the number of subjects in previous studies and in the current phase 3 study, the company anticipates that it may need approximately 70 additional subjects exposed to QS T for six months. The company is assessing the FDAs comments in the advice letter and their impact on the timing of the filing of a New Drug Application for QS T with the FDA. The timing, cost and design of the study to obtain the additional 70 subjects and data required will be determined based on further discussion with the FDA. The company continues to expect to release top-line pharmacokinetic data from the current phase 3 study in the second quarter of 2015.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use