ARRY Hits COLUMBUS Goals, KITE Flies After-hrs, FDA Places Hold On CVM Trial

(RTTNews) - Shares of Array BioPharma Inc. (ARRY) jumped more than 81% on Monday, following positive top-line results from Part 1 of the phase III study evaluating the combination of LGX818 and MEK162 compared to Vemurafenib alone in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

In the study, dubbed COLUMBUS, the combination of LGX818 and MEK162 significantly improved progression free survival compared with Vemurafenib, a BRAF inhibitor, alone.

According to the trial results, the median progression free survival for patients treated with the combination of LGX818 and MEK162 was 14.9 months versus 7.3 months for patients treated with Vemurafenib.

Data from Part 2 of the COLUMBUS study are anticipated in mid-2017.

ARRY closed Monday's trading at $6.61, up 81.10%. In after hours, the stock was up another 11.20% to $7.35.

The Biologics License Application for Romosozumab, an investigational drug for the treatment of osteoporosis in postmenopausal women at increased risk of fracture, has been accepted for review by the FDA, with a decision slated for July 19, 2017.

Romosozumab is being co-developed by Amgen (AMGN) and UCB.

AMGN closed Monday's trading at $173.53, down 0.73%.

CEL-SCI Corp.'s (CVM) phase III clinical trial of Multikine in advanced primary head and neck cancer has been placed on clinical hold. The study has enrolled about 926 patients.

The company noted that following the new development, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will continue to be followed.

CVM closed Monday's trading at $0.45, up 6.31%.

Shares of DURECT Corp. (DRRX) and its licensee, Pain Therapeutics (PTIE) were hit hard on Monday, following FDA's refusal to approve Remoxy ER.

Remoxy ER is a long-acting abuse-resistant narcotic analgesic formulation intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is formulated with Durect Corp.'s (DRRX) SABER technology under a joint development and license agreement entered into between Pain Therapeutics Inc. (PTIE) and Durect in December 2002.

In order for Remoxy ER to be approved, the FDA has asked the company to:

- Repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter. - Repeat a volatilization study using the same thickness for each drug to increase surface area and - Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.

DRRX closed Monday's trading at $1.16, down 31.76%. PTIE was down 51.28% to $1.33.

Gemphire Therapeutics Inc. (GEMP) has enrolled the first patient in its phase 2b trial designed to investigate Gemcabene in the treatment of homozygous familial hypercholesterolemia.

In the trial, dubbed COBALT-1, patients will be treated with an initial dose of 300 mg Gemcabene, which will be increased to 600 mg at 4 weeks and then 900 mg at 8 weeks. The primary endpoint will be the percent change from baseline of LDL-C at 4, 8, and 12 weeks.

The top-line data readout from the COBALT-1 study is expected in June 2017.

GEMP closed Monday's trading at $11.14, up 5.25%.

Shares of GW Pharmaceuticals plc (GWPH) rose over 17% on Monday, following positive results from its second phase III trial of investigational medicine Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare and severe form of childhood-onset epilepsy.

During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo. Patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo.

Positive results from the pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS were reported in June 2016. The company expects to submit a New Drug Application for Epidiolex to the FDA in the first half of 2017.

GWPH closed Monday's trading at $126.06, up 17.20%.

Early results from Idera Pharmaceuticals Inc.'s (IDRA) phase 1/2 clinical trial of intra-tumoral IMO-2125 in patients with metastatic melanoma who have failed prior PD-1 therapy has demonstrated that there is promising clinical activity in the treatment arm of IMO-2125 plus Ipilimumab compared to Ipilimumab treatment alone.

IMO-2125 in combination with Ipilimumab is being generally well tolerated at all 3 dose levels studied to date. No dose limiting toxicities have been identified to date and the study is currently enrolling at the highest (32mg) dosing cohort in combination with Ipilimumab, noted the company.

IDRA closed Monday's trading at $2.66, down 3.62%.

Jazz Pharmaceuticals plc's (JAZZ) two phase III studies evaluating JZP-110 in excessive sleepiness associated with obstructive sleep apnea are now fully enrolled with approximately 654 patients.

One of the two trials, dubbed Study 14-003, evaluated four doses of JZP-110 or placebo for a 12-week period and the other trial, known as Study 14-004, was a six-week, flexible-dose, randomized withdrawal study.

The company expects to report results from the two studies in the first quarter of 2017.

JAZZ closed Monday's trading at $123.79, down 2.67%.

Shares of Kite Pharma Inc. (KITE) were up more than 10% in extended trading on Monday, following positive topline results from a pre-planned interim analysis of a pivotal trial of its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma.

The trial, dubbed ZUMA-1, has two cohorts - Cohort 1 and Cohort 2.

Cohort 1, included patients with diffuse large B-cell lymphoma, and Cohort 2 enrolled patients with transformed follicular lymphoma and primary mediastinal B-cell lymphoma.

The interim analysis of ZUMA-1 evaluated the objective response rate in the first 51 patients in Cohort 1 with at least three months of follow-up. This analysis also included an additional 11 patients in Cohort 2.

According to the trial results, KTE-C19 met the primary endpoint of objective response rate, with ORR of 76 percent, including 47 percent complete remissions (CR).

The adverse events observed in the trial included neutropenia, anemia, febrile neutropenia, thrombocytopenia, encephalopathy, cytokine release syndrome (CRS) and neurological toxicity. Two patients died from KTE-C19 related adverse events say hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS, noted the company.

KITE closed Monday's trading at $54.98, up 0.75%. In after hours, the stock was up 10.22% to $60.60.

Shares of Lipocine Inc. (LPCN) were up more than 10% on Monday, following positive top-line results from a phase 2b clinical study of LPCN 1111, a novel oral testosterone replacement therapy product candidate.

The primary objectives of the study were to determine the phase 3 dose of LPCN 1111 along with the safety and tolerability of LPCN 1111 and its metabolites following oral administration of single and multiple doses in hypogonadal males.

The study has identified the dose that is to be tested in a phase 3 study, and there was a good dose-response relationship over the tested dose range in the study.

LPCN closed Monday's trading at $4.28, up 10.03%.

Summit Therapeutics plc (SMMT) has received Fast Track designation from the FDA for Ezutromid in the treatment of Duchenne muscular dystrophy.

Ezutromid is under a phase 2 DMD clinical trial, dubbed PhaseOut DMD.

As you may know, Sarepta Therapeutics Inc.'s (SRPT) EXONDYS 51 was granted accelerated approval by the FDA on September 19, 2016, becoming the first DMD treatment to be approved in the U.S.

SMMT closed Monday's trading at $10.24, up 16.47%.