EXEL Shines On Meteor Impact, GILD Gets FDA Date, VCEL Moving Ahead

(RTTNews) - Shares of Exelixis Inc. (EXEL) were up more than 8% in extended trading on Monday, following positive updated results from a subgroup analysis of the company's phase III pivotal trial of Cabozantinib in advanced renal cell carcinoma, dubbed METEOR.

The updated results are the first to include progression-free survival, or PFS, from the METEOR trial's entire 658-patient study population. The median PFS across all enrolled patients was 7.4 months for the Cabozantinib arm versus 3.9 months for the Eeverolimus arm. This corresponds to a 48% reduction in the rate of disease progression or death for Cabozantinib compared to Everolimus.

Last July, the company announced that the METEOR trial met its primary endpoint of demonstrating a statistically significant increase in PFS for Cabozantinib compared to Everolimus. That analysis was based on the first 375 patients and the rate of disease progression or death for Cabozantinib was 42% compared to Everolimus.

Exelixis completed the submission of its rolling New Drug Application with the FDA for Cabozantinib as a treatment for patients with advanced renal cell carcinoma last month.

Cabozantinib in capsule form is marketed under the brand name COMETRIQ in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. But Cabozantinib that was investigated in the METEOR trial is in tablet formulation, and is distinct from the COMETRIQ capsule form.

EXEL closed Monday's trading at $5.49, down 2.99%. In after-hours, the stock was up 8.93% at $5.98.

Gilead Sciences Inc.'s (GILD) New Drug Application for combo drug SOF/VEL as a treatment of all genotypes of chronic Hepatitis C infection has been granted priority review - with a decision date set for June 28, 2016.

SOF/VEL, which is designated a Breakthrough Therapy, is a combination of approved drug Sovaldi and investigational pan-genotypic NS5A inhibitor velpatasvir.

A marketing application for SOF/VEL is also under review in the European Union. Known chemically as sofosbuvir, Sovaldi was approved as a component of a combination antiviral treatment regimen for chronic HCV infection in December 2013. Sovaldi is taken in combination with ribavirin or in combination with pegylated interferon and ribavirin.

The price of Sovaldi for a 12-week course of treatment is $84,000.

The first combination drug for HCV is Harvoni, containing Sovaldi and Ledipasvir, which is also from Gilead's stable. Harvoni is also the first interferon-free and ribavirin-free hepatitis C treatment option to be green-lighted by the FDA.

A 12-week course of treatment with Harvoni costs $94,500, according to reports.

It remains to be seen what price tag Gilead will be putting on SOF/VEL if it gets approved.

GILD closed Monday's trading at $98.01, down 3.14%.

InVivo Therapeutics Holdings Corp. (NVIV) has received approval from FDA that will convert its ongoing pilot study of its biodegradable Neuro-Spinal Scaffold into a pivotal probable benefit study.

Accordingly, the trial will be known as INSPIRE study, and is currently approved to enrol up to 12 patients. But the company expects that the FDA will approve the full 20 patients following the review of the complete 6-month data package for the first five patients. The company plans to submit these data in the second quarter of 2016.

NVIV closed Monday's trading at $7.27, up 0.97%.

MabVax Therapeutics Holdings Inc. (MBVX.OB) has received authorisation from FDA to initiate a phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer.

The company may begin patient enrolment in the phase I clinical trial at multiple investigational sites in early 2016.

MBVX.OB closed Monday's trading at $0.74, up 8.03%.

Merck KGaA (MKGAY.OB), Pfizer Inc. (PF) and privately-held Syndax Pharmaceuticals Inc. have teamed up to evaluate Avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Entinostat, an investigational oral small molecule that targets immune regulatory cells, in patients with heavily pre-treated, recurrent ovarian cancer.

Financial terms of the agreement were not disclosed.

Avelumab is being co-developed by Merck KGaA and Pfizer while Entinostat is Syndax's proprietary lead molecule.

Syndax will be responsible for conducting the phase Ib/II clinical trial of Avelumab and Entinostat combination in ovarian cancer.

Syndax had filed for an IPO in June 2014, but withdrew its proposal last January.

PFE closed Monday's trading at $31.95, down 1.02%.

United-Guardian Inc. (UG) has received the go-ahead from the FDA to market Renacidin, the company's proprietary irrigating solution that is used to prevent and dissolve calcifications in indwelling catheters, in a new single-dose form.

The newly-approved drug product will be supplied in a 30mL single-use plastic bottle, and will replace the company's 500mL glass bottle.

The more user-friendly bottle of Renacidin will be available for distribution in March or April 2016, according to the company.

UG closed Monday's trading at $20.30, up 6.01%.

Vericel Corp. (VCEL) has submitted a Biologics License Application to the FDA for MACI, an investigational autologous cellular product intended for the treatment of symptomatic cartilage defects of the knee in adult patients.

MACI had been commercially available in the European Union since 1998. But it was only in 2013 did it receive marketing authorization in Europe. However due to low utilization and an unfavorable pricing environment, the sales of MACI were temporarily suspended in August 2014.

VCEL closed Monday's trading at $2.53, down 1.94%. In extended trading, the stock was up 2.77% at $2.60.