Be All EARS, DVAX Gets FDA Date, JAZZ Hits Right Notes, It's A No For OPK

(RTTNews) - Auris Medical Holding AG (EARS) has completed patient enrollment in its phase III clinical trial of AM-101 in acute inner ear tinnitus.

In the trial, dubbed TACTT2, which is being conducted primarily in North America, more than 330 patients have been randomized to receive either AM-101 0.87 mg/mL or placebo in a 3:2 ratio.

Top-line results from the TACTT2 trial are expected in August 2016.

The second phase III trial of AM-101, TACTT3, which is being conducted in Europe, will enroll approximately 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). Enrollment in this trial is expected to be completed in a few months.

EARS closed Wednesday's trading at $3.50, up 4.17%.

Dynavax Technologies Corp.'s (DVAX) Biologics License Application for HEPLISAV-B, the company's vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older, has been accepted for review by the FDA. The regulatory agency is scheduled to announce its decision on HEPLISAV-B on September 15, 2016.

DVAX closed Wednesday's trading at $18.05, down 2.01%. In after hours, the stock was up 1.99% to $18.41.

Genmab A/S (GMXAY.PK) said that a phase III trial of Daratumumab in combination with Velcade and corticosteroid Dexamethasone versus Velcade and Dexamethasone, dubbed Castor Study, in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival in an interim analysis.

Daratumumab, whose brand name is Darzalex, was granted accelerated approval by the FDA last November to treat patients with multiple myeloma who have received at least three prior treatments.

Janssen Biotech Inc. had licensed Daratumumab from Genmab in 2012.

GMXAY.OB closed Wednesday's trading at $68.20, up 5.41%.

Jazz Pharmaceuticals plc's (JAZZ) Defitelio has been approved by the FDA for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.

Defitelio becomes the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.

The company revealed that shipments of Defitelio to distribution channels will commence within a week.

JAZZ closed Wednesday's trading at $124.03, up 2.55%.

Lexicon Pharmaceuticals Inc. (LXRX) has submitted a New Drug Application to the FDA seeking approval of telotristat etiprate, an oral drug for the treatment of carcinoid syndrome.

Carcinoid syndrome is a rare disease affecting thousands of cancer patients with metastatic neuroendocrine tumors (mNETs) that have spread to the liver and other organs from the gastrointestinal tract. The condition is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Lexicon has requested a Priority Review by the FDA as part of the NDA filing.

LXRX closed Wednesday's trading at $12.30, up 3.80%. In after-hours, the stock gained another 1.63% to $12.50.

Opthea Limited has completed the targeted patient enrolment of 20 patients in its ongoing phase I dose escalation clinical trial of OPT-302 as a novel therapy for wet age-related macular degeneration.

The study is designed to evaluate the safety and clinical activity of intravitreal injections of OPT-302 either in combination with standard of care Lucentis or alone as monotherapy for patients with wet AMD.

The company expects to complete the 28 day safety assessment period for the OPT-302 highest dose level (2.0 mg) subjects in April which is a primary objective of the Phase 1 study. Additional detailed evaluation of longer term patient outcomes from the study is expected in the third quarter of this year when all of the enrolled subjects have completed dosing on a monthly basis for 3 months.

OXiGENE Inc.'s (OXGN) lead drug candidate CA4P has been granted Fast Track designation by the FDA for the treatment of platinum-resistant ovarian cancer.

The company is on track to enroll patients in its phase 2/3 clinical trial of CA4P in platinum-resistant ovarian cancer, dubbed FOCUS, before mid-year.

OXGN closed Wednesday's trading at $0.8280, up 17.43%.

Shares of Opko Health Inc. (OPK) were down over 10% in Wednesday's trading as the company's request to approve RAYALDEE as a treatment for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency was turned down by the FDA.

In its complete response letter, the only concern raised by the FDA related to third-party manufacturing observations. No new clinical studies have been requested and no new safety or efficacy issues have been identified.

OPK closed Wednesday's trading at $9.90, down 10.57%.

Radius Health Inc. (RDUS) has submitted a New Drug Application to the FDA for Abaloparatide-SC 80 mcg, an investigational, once daily treatment for postmenopausal women with osteoporosis.

In clinical studies, Abaloparatide-SC demonstrated significant reduction in the risk of vertebral, nonvertebral, clinical and major osteoporotic fractures and increase in bone mineral density.

In Europe, Abaloparatide-SC is currently undergoing regulatory review.

If approved, Abaloparatide-SC would be the first new bone anabolic treatment option in Europe since 2003 and the first in the U.S. since 2002 for postmenopausal women with osteoporosis.

RDUS closed Wednesday's trading at $32.83, up 6.45%.

Roche (RHHBY.OB) is all set to initiate collection and testing of blood samples for screening with the cobas Zika assay.

The cobas Zika test for use with the cobas 6800/8800 Systems is meant to detect Zika virus in plasma specimens from individual human blood donors and ensure that potentially infected blood units are not made available for transfusion.

Zika virus disease is a disease caused by Zika virus that is spread to people primarily through the bite of an infected Aedes species mosquito. The WHO declared Zika virus a public health emergency of international concern on Feb 1, 2016.

RHHBY.OB closed Wednesday's trading at $30.64, down 0.31%.

Retrophin Inc. (RTRX) has completed enrollment in its phase II study of Sparsentan for the treatment of focal segmental glomerulosclerosis.

The study, dubbed DUET, has exceeded its enrollment target of 100 patients, and top-line results are expected in the third quarter of 2016.

Focal segmental glomerulosclerosis (FSGS) is a rare kidney disorder without an approved pharmacological treatment option that often leads to end-stage renal disease.

RTRX closed Wednesday's trading at $13.39, up 4.69%.