GILD Files NDA For HCV Medicine, Canada Gets MonaLisa Touch, APRI Awaits Data

(RTTNews) - Apricus Biosciences Inc. (APRI) has completed enrollment in its phase 2b clinical trial of its novel product candidate, Fispemifene, in men with symptomatic secondary hypogonadism - reaching the target of 161 patients across 15 sites in the United States.

The company remains on track to report top-line results from this study during the first quarter of 2016.

APRI closed Wednesday's trading at $1.32, down 5.71%.

Bristol-Myers Squibb Co.'s (BMY) melanoma drug has received FDA approval for yet another indication - this time as adjuvant therapy for fully resected stage III melanoma.

Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. Today's approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery.

In a study, which compared patients who received Yervoy or a placebo as adjuvant therapy after complete surgical removal of melanoma, 49% of participants taking Yervoy had their cancer return after an average of 26 months while 62% of those receiving a placebo had their cancer return after an average of 17 months.

Early this month, Yervoy in combination with Opdivo received accelerated approval from the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer.

Yervoy is a monoclonal antibody that works by blocking CTLA-4, a molecule that may play a role in slowing down or turning off the body's immune system, and affects its ability to fight off cancerous cells.

Fatigue, diarrhea, itching, rash and nausea/vomiting are some of the common side effects associated with Yervoy while a serious, but uncommon side effect associated with the drug may be a fatal immune-mediated reaction.

Yervoy carries a black box warning of severe and fatal immune-mediated adverse reactions.

For the nine months ended September 30, 2015, Yervoy had worldwide sales of $861 million, down 9% from the year-ago period.

BMY closed Wednesday's trading at $67.59, up 1.18%.

Cynosure Inc.'s (CYNO) MonaLisa Touch for the treatment of symptoms related to Genitourinary Syndrome of Menopause has now received marketing clearance in Canada.

The symptoms of Genitourinary Syndrome of Menopause include vaginal dryness, vaginal burning, vaginal itching, pain, dysuria and dyspareunia. The condition affects approximately half of all postmenopausal women.

MonaLisa Touch received FDA clearance in September 2014.

CYNO closed Wednesday's trading at $37.81, up 3.50%.

Gilead Sciences Inc. (GILD) has submitted a New Drug Application to the FDA for SOF/VEL, an investigational, once-daily fixed-dose combination of the company's approved drug Sovaldi and investigational drug Velpatasvir, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The filing is the company's third in three years for a new HCV medicine.

The company plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year.

GILD closed Wednesday's trading at $108.13, down 2.55%.

Sanofi US, a subsidiary of Sanofi (SNY) is voluntarily recalling its product Auvi-Q, which is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions, due to potential inaccurate dosage delivery.

Auvi-Q is packaged with two active devices and one trainer device in a corrugate box, and was distributed throughout the United States via wholesalers, pharmacies and hospitals.

SNY closed Wednesday's trading at $51.49, up 1.86%.