TENX Awaits Data In Jan, GBIM Hit Hard, FDA Says No To SPPI

(RTTNews) - Shares of Apricus Biosciences Inc. (APRI) were down over 15% on Friday after the company announced that its re-submission of Vitaros NDA is likely to be delayed until the second half of 2017. The company was initially planning to re-submit the Vitaros NDA in the fourth quarter of this year.

Vitaros is a topical vasodilator cream in development for the treatment of erectile dysfunction. It was turned down by the FDA in 2008, with the regulatory agency raising concerns about the carcinogenic effects of Vitaros on transgenic mice in a study that was conducted in 2002.

APRI closed Friday's trading at $1.71, down 15.35%.

Shares of GlobeImmune Inc. (GBIM.OB) plunged more than 42% on Friday after the company announced that a collaboration and license agreement with Gilead Sciences Inc. (GILD), related to GS-4774, has been terminated.

Gilead has returned the rights to GS-4774, a therapeutic vaccine candidate against hepatitis B infection.

GlobeImmune has terminated the lease for 40,000 gross square feet of office, laboratory and manufacturing space which formerly served as the company's corporate headquarters.

GBIM.OB closed Friday's trading at $0.40, down 42.45%.

Spectrum Pharmaceuticals Inc. (SPPI) on Friday revealed that its New Drug Application for Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors has been turned down by the FDA.

In September of this year, an FDA panel voted against recommending Qapzola saying that it has not shown substantial evidence of a treatment effect over placebo.

SPPI closed Friday's trading at $4.27, unchanged from the previous day's close.

Tenax Therapeutics Inc. (TENX) has completed patient enrollment in its phase III trial evaluating Levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome and associated morbidity and mortality.

The trial, dubbed LEVO-CTS, has enrolled a total of 880 patients, and top-line results from this study are expected in January 2017.

TENX closed Friday's trading at $1.55, up 7.64%.