ACRX For The Long Haul, CLDX Disappoints, NVIV Inspires, MRNS Awaits Data

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) is all set to initiate the extension phase of its phase III study of ARX-04 (sufentanil tablet 30 mcg) in the management of moderate-to-severe acute pain in patients in an emergency room setting this month.

A new study of ARX-04 in postoperative patients with moderate-to-severe acute pain is underway. The two studies of ARX-04 are expected to be completed by the third quarter of 2016.

If all goes well as planned, the company anticipates submitting the NDA for ARX-04 in the fourth quarter of 2016.

In July 2014, the company was issued a Complete response Letter for Zalviso (sufentanil sublingual microtablet system), a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting. AcelRx expects to resubmit the NDA for Zalviso by the end of 2016.

Zalviso was approved by the European Commission last September, and the product is expected to be available to Western European patients in the first half of 2016.

ACRX closed Monday's trading at $4.00, up 2.83%. In after hours, the stock was down 8.25% to $3.66.

Shares of Celldex Therapeutics Inc. (CLDX) plunged more than 53% on Monday, following the company's decision to pull the plug on its phase III study of RINTEGA in newly diagnosed glioblastoma patients.

The decision to discontinue the trial was based on recommendation of the independent Data Safety and Monitoring Board, which determined that the trial was unlikely to reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other.

CLDX closed Monday's trading at $3.79, down 53.72%.

Eyegate Pharmaceuticals Inc. (EYEG) has acquired privately-held Jade Therapeutics Inc., a move that enhances the company's development pipeline with addition of new ophthalmic platform technology.

Jade's lead product candidate is a cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S), which possesses unique physical and chemical properties - making it well suited for treating various ocular surface injuries. CMHA-S is already marketed as a highly efficacious veterinary product by BayerDVM under the Remend brand to treat corneal wounds.

EyeGate intends to initiate a clinical study for Jade's lead product candidate for corneal epithelial defects in late 2016.

EYEG closed Monday's trading at $3.80, down 0.78%. In after hours, the stock was up 7.89% to $4.10.

Shares of InVivo Therapeutics Holdings Corp. (NVIV) surged over 29% on Monday, following encouraging six-month neurological progress for the fifth patient in the INSPIRE Study.

The INSPIRE Study is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption application for approval. The study is expected to enroll 20 patients.

So far, three out of the first five patients treated (60%) in the INSPIRE Study have had an improvement in their AIS grade by 6 months, according to the company. The AIS grade refers to a person's functional impairment as a result of their spinal cord injury.

The pivotal INSPIRE study is expected to complete full enrollment by the end of the year, which will allow for an HDE (Humanitarian Device Exemption) submission in 2017.

NVIV closed Monday's trading at $9.80, up 29.97%.

Marinus Pharmaceuticals Inc. (MRNS) is on-track to announce top-line results from its first pivotal phase III clinical trial of Ganaxolone in adults with drug-resistant focal onset seizures in mid-2016.

An exploratory phase II, investigator-sponsored clinical trial of Ganaxolone in children with Fragile X Syndrome is underway, and top-line results are anticipated in the first half of 2016.

The company plans to announce full data from an exploratory phase II clinical trial of Ganaxolone in PCDH19 pediatric epilepsy in mid-2016.

MRNS closed Monday's trading at $5.95, up 23.44%.

Vericel Corp.'s (VCEL) Biologics License Application for MACI, an investigational autologous cellular product, intended for the treatment of symptomatic cartilage defects of the knee in adult patients has been accepted for review by the FDA.

The regulatory agency is expected to announce its decision on MACI on January 3, 2017. No advisory committee meeting will be held to discuss the Biologics License Application for MACI.

VCEL closed Monday's trading 6.09% higher at $2.09.

Xencor Inc. (XNCR) has initiated a phase II trial of XmAb5871 in patients with IgG4-Related Disease and a phase II trial of XmAb5871 in patients with Systemic Lupus Erythematosus.

The phase II pilot study in IgG4-RD is designed to enroll approximately 15 patients with active IgG4-RD, who will receive intravenous administrations of XmAb5871 every 2 weeks for 6 months. The phase II study in Systemic Lupus Erythematosus will enroll roughly 90 patients who will be randomized 1:1 to receive XmAb5871 or placebo.

XNCR closed Monday's trading 3.99% higher at $12.00. In after hours, the stock was up another 19.42% to $14.33.