ARLZ Hands Out Pink Slips, JAZZ On A High Note, STDY On Track, TENX Abuzz

(RTTNews) - Shares of Aralez Pharmaceuticals Inc. (ARLZ) plunged more than 16% on Wednesday after the Company announced that it is reducing its U.S. sales force by 32%.

The Company is also realigning certain financial resources to support a successful phased launch of Zontivity that is expected to begin in mid-April, together with a significant decrease in marketing spend on Yosprala.

Zontivity, developed by Merck, is indicated for the prevention of cardiovascular events in high risk patients. Aralez acquired the U.S. and Canadian rights to Zontivity from Merck last September.

Yosprala is Aralez's drug approved for the secondary prevention of cardiovascular disease in patients at risk for Aspirin-associated gastric ulcers.

The Company added that the reduction in sales force is expected to reduce the current annual run rate of operating expenses by approximately $7.5 million. As a result of this sales force reduction, the Company anticipates it will incur cash severance costs of approximately $0.6 million in the second quarter of 2017. The sales force restructuring is expected to yield savings for 2017 and beyond.

ARLZ closed Wednesday's trading at $1.77, down 16.51%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) is required to conduct a single phase III study to support a New Drug Application for Anabasum for the treatment of diffuse cutaneous systemic sclerosis.

The international phase III trial is designed to enroll approximately 270 adults with systemic sclerosis. Subjects will be randomized to receive Anabasum 20 mg twice per day, Anabasum 5 mg twice per day, or placebo twice per day.

Corbus expects to enroll its first patient in the study in the fourth quarter of 2017.

CRBP closed Wednesday's trading at $7.75, down 3.73%.

Jazz Pharmaceuticals plc (JAZZ) has reached a settlement with London-based Hikma Pharmaceuticals plc related to Xyrem patent litigation.

Xyrem is Jazz Pharma's drug, which is indicated for the treatment of both cataplexy and excessive daytime sleepiness, or EDS, in patients with narcolepsy.

In 2010, Jazz sued Roxane Laboratories Inc., which is now owned by Hikma, over its bid for approval to market a generic version of Xyrem. Roxane on its part has been arguing that Jazz's patent covering Xyrem is invalid.

Xyrem generated sales of $1.10 billion in 2016 for Jazz Pharma, up from $955 million in 2015. The first generic version of Xyrem, produced by Roxane Laboratories, was approved by the FDA in January of this year.

Now that a settlement has been reached, Jazz has granted Hikma and its wholly owned subsidiary, West-Ward Pharmaceuticals Corp., the right to sell an authorized generic (AG) version of Xyrem in the U.S. under the Xyrem New Drug Application, commencing on January 1, 2023, or earlier under certain circumstances customary for settlement agreements of this nature.

The initial term of the authorized generic arrangement is six months, and Hikma has the option to continue the sale of the authorized generic product for up to a total of five years.

Jazz will receive a meaningful royalty on net sales of the authorized generic product, with the royalty rate increasing during the initial authorized generic term based on increased authorized generic sales. There will be a substantial increase in the royalty rate should the AG term be extended beyond one year, Jazz Pharma noted.

JAZZ closed Wednesday's trading at $140.65, down 1.79%. In after-hours, the stock was up 5.86% to $148.89.

Oncolytics Biotech Inc.'s (ONCYF.OB) drug candidate REOLYSIN more than doubled overall survival in patients with mutated p53 metastatic breast cancer in a phase II study.

In the phase II study that enrolled 74 patients with metastatic breast cancer, 61 patients or 82% of them had p53 mutated tumors.

According to the study results, patients with mutated p53 metastatic breast cancer that were treated with REOLYSIN in combination with paclitaxel had a median overall survival of 20.9 months versus 10.4 months in patients treated only with paclitaxel.

A registration study in metastatic breast cancer, with a focus on p53 mutations, is being designed with overall survival as the primary endpoint, the Company noted.

ONCYF.OB closed Wednesday's trading at $0.550, up 8.93%.

Prometic Life Sciences Inc. (PLI.TO) (PFSCF.OB) has completed the filing of its Biologics License Application for Plasminogen with the FDA for the treatment of patients with plasminogen congenital deficiency.

Plasminogen replacement therapy has been granted Orphan Drug and Fast Track Designations by the FDA.

Prometic has also applied for a pediatric designation as its research demonstrates that the most serious and life-threatening manifestations of the congenital plasminogen deficiency occur most commonly in pediatric patients.

PLI.TO closed Wednesday's trading at $2.19, down 0.45%.

SteadyMed Ltd. (STDY) has successfully completed a clinical validation study for its lead drug product candidate, Trevyent.

The study was meant to evaluate the essential safety and performance functions of Trevyent's proprietary delivery system, including dose accuracy and precision, as well as tolerability for on-body application of the product.

The Company remains on track to submit a New Drug Application for Trevyent to treat Pulmonary Arterial Hypertension in the second quarter of 2017.

STDY closed Wednesday's trading at $6.80, up 2.26%.

The FDA has granted final approval to Supernus Pharmaceuticals Inc.'s (SUPN) Supplemental New Drug Applications requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults and adolescents 12 years and older.

Trokendi XR, which is available as 25mg, 50mg, 100mg, and 200mg strength tablets in 100-count bottles and as 30-count blister packages, is also indicated for the treatment of epilepsy.

The net product sales of Trokendi XR in 2016 were $158.4 million compared with $110.3 million in 2015.

SUPN closed Wednesday's trading at $30.15, down 2.43%. In after-hours, the stock was up 4.31% to $31.45.

Tenax Therapeutics Inc. (TENX), which has been hit hard by the recent failure of its phase III trial of Levosimendan, is conducting a comprehensive review of strategic alternatives focused on maximizing stockholder value.

The Company announced that it has engaged Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (LTS), as its financial advisor to assist in the strategic review process.

The strategic review process, includes, and is not limited to a merger, a business combination, a strategic investment into the Company, or a purchase, license or other acquisition of assets.

Tenax noted that it does not intend to disclose additional details unless and until it has entered into a specific transaction.

Early, this year, the Company announced that its phase III trial of Levosimendan for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome failed to meet the endpoint.

TENX closed Wednesday's trading at $0.48, down 4.60%. In after-hours, the stock was up 21.59% to $0.58.