BIND Extends Agreement Terms, HRTX Awaits MAGIC, CBRX Renamed

(RTTNews) - Shares of BIND Therapeutics Inc. (BIND) rose more than 9% in extended trading on Thursday after the company announced an extension of the terms of its global collaboration with Pfizer Inc. (PFE) to create Accurins that optimize the therapeutic potential of two molecularly targeted oncology drugs in Pfizer's pipeline.

Accurins represent the next stage in the evolution of targeted therapies and nanomedicine.

The collaboration was originally established in April 2013 and the timeline for Pfizer to exercise its option to acquire the exclusive license for the first program continues to be September 2015. Both companies agreed to an extension of the timeline for the second program through March 2016.

BIND received an upfront payment of $4.0 million in 2013, a $1.0 million preclinical development milestone in December 2014, and has the potential to receive payments up to $88.5 million upon the achievement of additional specified development and regulatory events. BIND may also receive additional payments up to $110 million for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of each Accurin commercialized, if any.

BIND closed Thursday's trading 2.41% higher at $5.52. In after-hours, the stock was up 9.60% at $6.05.

Columbia Laboratories Inc. (CBRX) is all set to take on a new name "Juniper Pharmaceuticals Inc." effective April 10, 2015, and the company's common stock will begin trading on the Nasdaq Stock Exchange under the new ticker symbol - "JNP" - on April 13, 2015.

The company expects to initiate a phase II clinical trial lCOL-1077, a 10% lidocaine bioadhesive gel, later this quarter. This study will evaluate the efficacy of COL-1077 for use as an acute anesthetic for women undergoing transvaginal pipelle-directed endometrial biopsy.

CBRX closed Thursday's trading at $6.18, up 0.65%.

Heron Therapeutics Inc. (HRTX) has reached its enrollment target in a phase III study evaluating the efficacy of SUSTOL in the prevention of delayed-onset CINV following administration of highly emetogenic chemotherapy agent.

The study, dubbed MAGIC, has enrolled approximately 900 patients, and top-line results from the study are expected in May 2015.

Heron expects to resubmit the NDA for SUSTOL around the middle of this year, and it will include data from the MAGIC study.

The SUSTOL NDA, which was initially filed in May 2009, was issued a Complete Response Letter in March 2010. In September 2012, the company resubmitted its NDA for SUSTOL only to be issued a Complete Response Letter again in March 2013.

HRTX closed Thursday's trading at $14.07, down 1.05%.

Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson (JNJ), has completed the divestiture of its U.S. license rights to NUCYNTA, NUCYNTA ER extended-release tablets and NUCYNTA oral solution to Depomed Inc. (DEPO) for $1.05 billion.

However, Janssen Pharma will retain license rights to the above-mentioned products in Canada, Japan, and a number of other countries outside the United States.

JNJ closed Thursday's trading at $99.64, up 0.49%.

SAGE Therapeutics (SAGE) plans to begin enrollment of its phase 3 clinical trial of its drug candidate SAGE-547 for the treatment of patients with super-refractory status epilepticus mid-year.

The phase 3 clinical trial will assess the efficacy and safety of SAGE-547 in approximately 126 patients with super-refractory status epilepticus, aged two years or older, at up to 150 sites in the U.S. and Europe.

The company anticipates reporting clinical data from its phase 1/2 open-label clinical trial of SAGE-547 at the Antiepileptic Drug and Device Trials XIII Conference, which is taking place May 13-15.

SAGE closed Thursday's trading at $46.87, down 7.85%.

Thoratec Corp. (THOR) has received final approval from the FDA to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites, following the regulatory agency's evaluation of safety data from the first ten HeartMate III implants performed in recent months during a limited enrollment phase at five sites.

HeartMate III is a centrifugal-flow chronic left ventricular assist system designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size.

The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with FDA-approved HeartMate II including a primary endpoint of survival free of device replacement and debilitating stroke.

Outside of the U.S., Thoratec completed enrollment of the HeartMate III CE Mark study in late 2014 and continues to expect a commercial approval and launch in European markets during late 2015.

THOR closed Thursday's trading at $41.77, up 0.34%.