Data Due Mid Year For CORT, New Addition To HCV Armory, EXEL Gets FDA Date

(RTTNews) - Avanir Pharmaceuticals Inc., an independent subsidiary of Otsuka America Inc., has secured FDA approval for ONZETRA Xsail, formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults.

ONZETRA Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail Breath Powered Delivery Device, according to the company.

Avanir was trading on the NASDAQ before it was acquired by Japanese drug giant Otsuka Pharmaceutical Co. for $3.5 billion or $17 per share in cash in December 2014.

Corcept Therapeutics Inc. (CORT) has a couple of clinical trial catalysts lined up for this year. The company expects results from a phase 1/2 trial of Mifepristone in combination with Eribulin in triple-negative breast cancer patients by mid-year.

The company also plans to begin two phase II studies with its next-generation, selective cortisol modulator, CORT125134, by the end of the first quarter.

CORT closed Thursday's trading at $3.28, down 6.29%.

Exelixis Inc.'s (EXEL) New Drug Application for Cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy has been granted priority review - with a decision date set for June 22, 2016.

The company completed the submission of its rolling New Drug Application for Cabozantinib to the FDA on December 23, 2015.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.

EXEL closed Thursday's trading at $4.18, down 2.79%.

Another drug has been added to the HCV armamentarium following the FDA approval of Merck's (MRK) ZEPATIER.

ZEPATIER, a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg) is indicated for the treatment of adult patients with chronic hepatitis C virus genotype 1 or 4 infection, with or without ribavirin.

In clinical studies, ZEPATIER achieved high rates of sustained virologic response ranging from 94 to 97 percent in genotype 1 patients, and 97 to 100 percent in genotype 4 patients.

The company anticipates that ZEPATIER will be available for shipping to wholesalers within seven business days.

The list price for a 12-week regimen of ZEPATIER is $54,600, according to Merck.

MRK closed Thursday's trading at $49.20, down 2.32%. In after hours, the stock was up 3.37% to $50.50.

Rigel Pharmaceuticals Inc. (RIGL) has completed enrollment in the first of two phase III clinical studies of Fostamatinib in immune thrombocytopenic purpura.

Immune thrombocytopenic purpura is a blood disorder in which the immune system attacks and destroys platelets in the blood, resulting in an abnormally low platelet count.

The phase III program of of Fostamatinib consists of two identical studies of 75 patients each. The primary efficacy endpoint of this program is a stable platelet response by week 24 with platelet counts at or above 50,000 per microliter of blood for at least four of the final six qualifying blood draws.

The results from the first phase III study are expected in the middle of 2016, followed by the second study results shortly thereafter.

RIGL closed Thursday's trading at $2.58, down 0.39%.

Sophiris Bio Inc. (SPHS) says the preliminary results from a phase 2a proof-of-concept study of PRX302 in localized prostate cancer are encouraging.

According to the company, a review of the biopsy data from the first seven men to complete the study showed that four patients experienced a response to treatment: One patient experienced complete ablation of the tumor where no evidence of the treated tumor remained on a targeted biopsy at 6 months; three patients experienced either a reduction in the maximum cancer core length or a reduction in Gleason pattern; three patients had no response to treatment.

The study has enrolled 18 patients in this study, and final data on all patients are expected by the end of the second quarter of 2016.

SPHS closed Thursday's trading at $2.04, down 1.45%.