TTNP On A High, Double Blessing For NERV, AVIR In Trouble, SAGE Awaits Data

(RTTNews) - Shares of Aviragen Therapeutics Inc. (AVIR) fell more than 13% in extended trading on Thursday as the company voluntarily decided to delay further enrollment in its phase IIa trial of BTA585 for the treatment of RSV infections being conducted in the U.K.

The decision to delay further enrollment comes in the wake of lab report from one subject showing an increase of a cardiac enzyme level coupled with transient ECG changes, which led to a hospitalization of less than 24 hours.

The FDA has verbally communicated to the company that the investigational new drug application for BTA585 has been placed on clinical hold for studies being conducted in the U.S. under the IND. There are currently no trials of BTA585 being conducted under the IND, noted the company.

AVIR closed Thursday's trading at $1.59, down 0.62%. In after hours, the stock was down 13.21% to $1.38.

The Medicines Co. (MDCO) has completed patient enrollment in its phase III study of CARBAVANCE for the treatment of complicated urinary tract infections. Top-line data from this study, dubbed TANGO 1, are expected in the second half of 2016.

MDCO closed Thursday's trading at $37.22, down 0.13%.

Shares of Minerva Neurosciences Inc. (NERV) rose as much as 273% on Thursday, following positive results from two phase II trials - one in schizophrenia and the other in major depressive disorder.

In a phase IIa clinical trial in major depressive disorder, the company's drug candidate MIN-117, demonstrated a reduction in depressive symptoms, good tolerability and safety profile, and positive effect on sleep architecture.

In a phase IIb trial in schizophrenia, the drug candidate MIN-101 showed statistically significant improvement in PANSS negative symptoms and total PANSS scores, the study's primary endpoint.

NERV closed Thursday's trading at $11.80, up 233.33%.

Sage Therapeutics Inc. (SAGE) has completed enrollment in its phase II placebo-controlled, proof-of-concept clinical trial of SAGE-547 in women with severe postpartum depression.

The company now expects to report results from the study in July 2016.

SAGE closed Thursday's trading at $31.41, down 1.01%.

Shares of Titan Pharmaceuticals Inc. (TTNP) were up over 20% in extended trading on Thursday, following FDA approval of Probuphine implant for the treatment of opioid dependence.

The Probuphine subdermal implant becomes the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

Titan Pharma has a license agreement, signed in 2012, that grants Braeburn Pharmaceuticals Sprl exclusive commercialization rights in the United States and Canada to Probuphine.

Under the Braeburn license, Titan will receive a $15 million milestone payment for the FDA approval as well as double-digit tiered royalties, and is eligible for sales milestones of up to $165 million.

The product is expected to be commercially available this summer.

TTNP closed Thursday's trading at $7.07, up 1.29%. In after hours, the stock was up 20.93% to $8.55.

Vanda Pharmaceuticals Inc.'s (VNDA) Fanapt, an antipsychotic medication used to treat schizophrenia, has been approved by the FDA in the additional indication as a maintenance treatment for schizophrenia in adults.

The approval was based on data from a study, known as REPRIEVE, which showed that 79.6% of patients treated with Fanapt remained relapse free compared to 36.6% for placebo-treated patients.

Fanapt received its first FDA approval to treat adults with schizophrenia in 2009. The drug generated net product sales of $65.6 million for the full year 2015 compared to $65.0 million in 2014.

VNDA closed Thursday's trading at $9.49, down 2.37%. In after-hours, the stock was up 5.48% to $10.01.