IMMU Chugs Along, MNKD Decision Delayed, QCOR Bought Out, Another First For ISR

(RTTNews) - Bristol-Myers Squibb Co. (BMY) has submitted new drug applications with FDA for its investigational products Daclatasvir and Asunaprevir seeking approval for their combined use in patients with genotype 1b hepatitis C.

The Daclatasvir NDA also seeks approval for its in combination with other agents for multiple genotypes.

BMY closed Monday's trading at $50.28, up 0.78%.

Gilead Sciences Inc.'s (GILD) New Drug Application for a once-daily fixed-dose combination Ledipasvir 90 mg and Sofosbuvir 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults has been granted priority review by FDA, and a decision date has been set for October 10, 2014.

GILD closed Monday's trading at $72.23, up 0.04%.

Helix BioPharma Corp. (HBP.TO) has initiated the eighth dose level cohort in its ongoing phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland. The first treatment cycle in the three patients enrolled in the seventh dose level cohort has been completed, and according to the company, L-DOS47 therapy was well tolerated as reviewed by the Trial Steering Committee.

A more detailed update on the status of the first seven patient cohorts is expected to be provided by the end of the second calendar quarter of 2014.

HBP.TO closed Monday's trading at $C$1.41, unchanged from the previous day's close.

Immunomedics Inc.'s (IMMU) investigational antibody-drug conjugate IMMU-130 has proven to be more therapeutically active in patients with metastatic colorectal cancer when administered once or twice-weekly for 2 weeks followed by a week off than when administered every other week in phase I trials.

A phase II trial evaluating once or twice-weekly dosing for 2 weeks in a 21-day cycle is ongoing in metastatic colorectal cancer.

IMMU closed Monday's trading 1.80% higher at $3.95.

IsoRay Inc. (ISR) announced that the world's first human prostate implant utilizing its Cesium-131 seeds with C4 Imaging's Sirius positive signal MRI markers has been performed.

Steven Frank of MD Anderson Cancer Center, who performed the implant, said that IsoRay's Cesium-131, with its short half-life, offers rapid resolution of the acute side effects that can be associated with prostate treatment with brachytherapy.

Last month, the company announced the successful completion of the world's first pediatric Cesium-131 seeded mesh treatment for metastatic Wilms Tumor.

Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body.

ISR closed Monday's trading at $3.16, up 4.29%.

MannKind Corp. (MNKD) said that the FDA decision on its New Drug Application for inhalable insulin AFREZZA has been postponed by three months to July 15, 2014. The extension is to provide time for the FDA for a full review of information submitted by MannKind in response to the regulatory agency's requests.

Last week, an FDA panel, which reviewed the AFREZZA NDA, recommended its approval to treat diabetes.

MNKD closed Monday's trading at $6.32, down 8.01%.

Questcor Pharmaceuticals Inc. (QCOR) is all set to be acquired by Mallinckrodt pharmaceuticals in a deal valued at approximately $5.6 billion.

According to the terms of the deal, Questcor shareholders will receive $30.00 in cash and 0.897 Mallinckrodt shares for each share of Questcor common stock they own. Subject to customary closing conditions, the transaction is currently expected to be completed in the third calendar quarter of 2014.

RedHill Biopharma Ltd. (RDHL) is planning to submit a Marketing Authorization Application for its drug candidate RHB-102 in Europe during the second half of the year.

RHB-102 is a patent-protected, extended-release (24 hours) oral pill formulation of ondansetron, the active ingredient in GlaxoSmithKline's Zofran for the prevention of radiotherapy-induced nausea and vomiting and chemotherapy-induced nausea and vomiting.

TherapeuticsMD Inc.'s (TXMD) drug candidate for the treatment of Vulvar Vaginal Atrophy - TX 004-HR - has proven to be a "non-irritant" following a 28-day repeated application to the vaginal mucosa in a rabbit irritation study.

Now that TX 004-HR has passed the toxicity hurdle, it will move forward to late phase clinical testing, said the company.

TXMD closed Monday's trading at $5.04, down 3.63%.