IPCI Continues To Move Up, NBIX To Face FDA In April, Good Tidings From NYMX

(RTTNews) - Shares of Intellipharmaceutics International Inc. (IPCI) (I.TO) have been on the move upwards ever since winning FDA tentative approval for its generic version of schizophrenia and bipolar disorder drug Seroquel XR, on October 7, 2016.

In extended trading on Tuesday, the company's stock gained more than 16%, following a 10-year license and commercial supply agreement with Mallinckrodt LLC.

As per the agreement terms, Mallinckrodt has been granted an exclusive license to market, sell and distribute in the United States the following namely,

- Quetiapine fumarate extended-release tablets (generic Seroquel XR) — ANDA Tentatively Approved by FDA - Desvenlafaxine extended-release tablets (generic Pristiq) — ANDA under FDA Review - Lamotrigine extended-release tablets (generic Lamicta XR) — ANDA under FDA Review

The agreement entitles Intellipharmaceutics to receive a non-refundable upfront payment of US$3 million in October 2016, and also sets a long-term profit sharing arrangement with respect to the licensed products.

IPCI closed Tuesday's trading at $2.83, down 0.35%. In after-hours, the stock was up 16.25% to $3.29.

Shares of Nymox Pharmaceutical Corp. (NYMX) jumped over 12% on Tuesday after the company reported that its new phase III long-term results of prostate enlargement drug Fexapotide has shown dramatic decrease in prostate cancer and that there was a major reduction in need for BPH prostate surgery.

The results were based on the 7-year follow-up of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement who received Fexapotide or placebo.

In the Fexapotide treated arm, rate of prostate cancer incidence after 7 years was as low as 1.3%. According to a U.S. study, the results of which were published in the Journal of Urology, in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5%.

NYMX closed Tuesday's trading at $3.67, up 12.92%.

Neurocrine Biosciences Inc.'s (NBIX) New Drug Application for INGREZZA for the treatment of tardive dyskinesia has been accepted for priority review by the FDA, and the decision date has been set for April 11, 2017.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips. These symptoms are rarely reversible and there are currently no FDA approved treatments.

NBIX closed Tuesday's trading at $45.00, down 3.39%.

Roka Bioscience Inc. (ROKA) is implementing a 1-for-10 reverse stock split of its common stock, which will come into effect on October 12, 2016, in order to help it regain compliance with NASDAQ $1.00 minimum bid price requirement.

The reverse split will reduce the number of outstanding shares of the company's common stock from approximately 17.8 million to approximately 1.8 million.

ROKA closed Tuesday's trading at $0.65, down 12.16%.

Shares of Supernus Pharmaceuticals Inc. (SUPN) fell more than 6% on Tuesday, despite reporting positive results from its phase IIb dose-ranging clinical trial of SPN-812 in children for the treatment of attention deficit hyperactivity disorder.

The trial involved a total of 222 patients who were randomized to receive placebo or any of the four doses of SPN-812 (100/200/300/400mg). The primary outcome measure was the change from baseline to the end of the study in the ADHD-RS-IV total score.

According to the trial results, SPN-812 400 mg, 300 mg and 200 mg doses were statistically significant compared to placebo in the primary endpoint. But patients receiving SPN-812 100 mg had a -16.7 point change from baseline in the primary endpoint and a median effect size of 0.46, which did not quite reach statistical significance.

SUPN closed Tuesday's trading at $23.00, down 6.84%.