MDCO Gets FDA Nod For 2 Products, EXEL Awaits METEOR Data, WX To Make History

(RTTNews) - Exelixis Inc. (EXEL) now expects top-line results from its phase 3 pivotal trial of its drug candidate Cabozantinib in metastatic renal cell carcinoma to be available at the end of the second quarter or early in the third quarter of this year. Results from this study, dubbed METEOR, were previously anticipated to be available in the second quarter of 2015.

EXEL closed Thursday's trading at $2.57, down 6.50%. In after-hours, the stock gained 3.89% to $2.67.

The Medicines Co.'s (MDCO) RAPLIXA and RaplixaSpray device have received FDA approval to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques such as suture, ligature and cautery are ineffective or impractical.

RAPLIXA becomes the first and only powdered fibrin sealant ready-to-use for mild to moderate surgical bleeding.

The company has also secured FDA approval for IONSYS (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital.

The company expects IONSYS to be available in the U.S. in Q3 2015.

MDCO closed Thursday's trading at $25.61, down 1.69%.

Lipocine Inc. (LPCN) has completed the safety assessment portion of its pivotal phase 3 clinical study of LPCN 1021, an oral testosterone product, in hypogonadal men with low testosterone.

The company reported positive top line efficacy from this study, dubbed SOAR, in September 2014 and expects to announce top-line results from the 52 week safety assessment portion by mid-year as well as file the NDA in the second half of this year.

LPCN closed Thursday's trading at $6.64, down 0.90%.

OncoGenex Pharmaceuticals Inc. (OGXI) has filed an amendment with the FDA and has initiated filing with regulatory agencies in other countries, to amend the statistical design and analysis plan of its pivotal, international phase 3 ENSPIRIT trial evaluating Custirsen in the treatment of non-small cell lung cancer.

OncoGenex recently regained the rights to the investigational compound Custirsen from Teva Pharmaceuticals Ltd. (TEVA) and is currently in the process of assuming sponsorship for all clinical development related to the compound.

OGXI closed Thursday's trading at $2.01, down 3.83%.

Retrophin Inc. (RTRX) is all set to initiate a phase 1 trial of RE-024 in healthy adult subjects to evaluate safety, tolerability, and pharmacokinetics, with enrollment expected to begin in the coming weeks.

RE-024 is being developed for the treatment of pantothenate kinase-associated neurodegeneration (PKAN), a rare and lethal autosomal recessive neurodegenerative disorder believed to affect approximately one to three persons per million worldwide. There is no approved treatment for this disorder.

RTRX closed Thursday's trading at $21.54, down 5.48%.

Breo Ellipta, co-developed by Theravance Inc. (THRX) and GlaxoSmithKline plc (GSK), has won FDA approval for yet another indication - this time, for the once-daily treatment of asthma in patients aged 18 years and older.

However, the regulatory agency declined to approve the proposed use of Breo Ellipta in patients aged 12-17 stating that the data submitted do not show adequate risk-benefit to support the approval in these patients.

Breo Ellipta was initially approved by the FDA in May 2013 as a prescription medication for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

THRX closed Thursday's trading at $16.25, down 4.80%. In after-hours, the stock was up 1.78% at $16.54.

TESARO Inc. (TSRO) has completed the targeted enrollment of 490 patients in a phase III trial evaluating its drug candidate Niraparib in patients with high grade serous, platinum sensitive, relapsed ovarian cancer.

The company expects results from this trial, dubbed NOVA, to be available in the fourth quarter of 2015.

In addition, a single arm, phase II clinical trial of Niraparib, known as QUADRA, that is targeted to enroll 225 patients with high grade serous ovarian cancer who have received three or more prior lines of chemotherapy has been initiated. Initial data from this trial is anticipated in early 2016.

TSRO closed Thursday's trading at $54.47, down 10.79%.

WuXi Biologics, a wholly owned subsidiary of WuXi PharmaTech (Cayman) Inc. (WX), has begun construction of the world's largest mammalian cell culture manufacturing facility using disposable bioreactors.

The new $150 million biologics manufacturing facility in Wuxi city, which will house fourteen 2000L disposable bioreactors for fed-batch cell culture and two 1000L bioreactors for perfusion runs, is scheduled for completion by January 2017.

WX touched a new high of $45 on Thursday before closing the day's trading at $43.17, up 9.29%.