ADXS Makes It Big, ALKS Waiting To Face FDA, ITMN Snapped Up, KITE Flies High

(RTTNews) - Advaxis Inc. (ADXS) and Merck & Co. Inc. (MRK) have entered into a clinical trial collaboration agreement to evaluate the combination of two novel immunotherapy candidates for advanced prostate cancer.

Accordingly, a phase 1/2 study has been planned which will evaluate Advaxis' Lm-LLO cancer immunotherapy, ADXS-PSA as monotherapy and in combination with Merck's investigational anti PD-1 antibody, Pembrolizumab, in patients with previously treated metastatic, castration-resistant prostate cancer.

ADXS rose 23.08% on Monday to close the day's trading at $4.

Alkermes plc (ALKS) has submitted a New Drug Application to the FDA for approval of its investigational, novel, once-monthly, long-acting injectable atypical antipsychotic - Aripiprazole lauroxil - for the treatment of schizophrenia. Within 60 days, the company will know whether or not its NDA has been accepted for filing.

ALKS closed Monday's trading at $44.22, up 2.27%.

Immunomedics Inc. (IMMU) expects top-line results from its two phase III EMBODY trials evaluating Epratuzumab in patients with moderate or severe systemic lupus erythematosus to be released in the first half of calendar year 2015.

IMMU closed Monday's trading at $3.56, up 3.49%. In after-hours, the stock was down 1.69% to $3.50.

Insys Therapeutics Inc.'s (INSY) pharmaceutical Cannabidiol has been granted orphan drug designation by FDA for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor in humans.

The pharmaceutical Cannabidiol (CBD) is a synthetically produced and more than 99% pure form of cannabidiol. Cannabidiol is the antipsychotic component of Cannabinoids.

Insys' pharmaceutical CBD was earlier granted orphan drug designation for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome, both rare forms of epilepsy. The company plans to file an Investigational New Drug application for pharmaceutical Cannabidiol with the FDA in the second half of 2014 for the treatment of epilepsy.

INSY closed Monday's trading at $35.48, down 0.20%.

InterMune Inc. (ITMN) climbed more than 35 percent to $72.85 on Monday, following Roche's offer to buy the company at $74.00 per share equivalent to a total value of $8.3 billion, in an all-cash transaction.

The merger agreement has been approved by the boards of InterMune and Roche. The closing of the transaction is expected to take place this year.

Shares of Kite Pharma Inc. (KITE) surged over 28 percent to $28.70 in after-hours Monday following publication of positive findings about an anti-CD19 chimeric antigen receptor (CAR) T cell therapy in an ongoing phase 1-2a clinical trial.

The ongoing phase 1-2a clinical trial, funded by Kite and conducted by the Surgery Branch of the National Cancer Institute (NCI) demonstrated that in 12 out of 13 evaluable patients with advanced B-cell malignancies, administration of anti-CD19 CAR T cells resulted in complete remission in eight patients and partial remission in four patients, representing an overall objective response rate of 92%. Of seven evaluable patients with chemotherapy-refractory Diffuse Large B-cell Lymphoma, four achieved complete remission, three of which are ongoing with durations ranging from 9 to 22 months.

Kite Pharma's most advanced product candidate, KTE-C19, is also an anti-CD19 CAR T cell therapy. The company plans to file an IND in the fourth quarter of this year to initiate a phase 1-2 single-arm multicenter clinical trial of KTE-C19 in patients with Diffuse Large B-cell Lymphoma who have failed two or more lines of therapy. Patient enrollment in the DLBCL clinical trial is anticipated to commence in the first half of 2015.

La Jolla Pharmaceutical Co. (LJPC) has enrolled the first patient in its phase 1/2 clinical trial of LJPC-501 for the treatment of type 1 and type 2 hepatorenal syndrome (HRS). The trial is designed to enroll up to 15 patients with type 1 or type 2 HRS.

HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.

LJPC closed Monday's trading at $10.50, up 3.14%. In after-hours, the stock gained 3.62% to $10.88.

VIVUS Inc. (VVUS) has acquired a group of patents from Johnson & Johnson's subsidiary Janssen Pharmaceuticals Inc. covering uses of Topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions.

It should be noted that the only marketed product of VIVUS - Qsymia, a weight-management drug - contains Topiramate as one of its ingredients. Janssen had filed a patent suit against VIVUS on August 22, 2014 in the U.S. District Court for the District of Delaware.

Now that Janssen's Topiramate-related patents have been acquired by VIVUS, Janssen has agreed to dismiss the lawsuit.

VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of the Topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.

VVUS closed Monday's trading at $4.17, down 0.71%.