ADXS Plunges On Clinical Hold, AVXL Prepares For Uplisting, Nu Skin Peeling Off

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) has initiated an open-label phase III study of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury.

The study is expected to be completed in early 2016.

ACRX closed Tuesday's trading at $3.48, up 4.19%.

Shares of Advaxis Inc. (ADXS) plunged more than 25% in after-hours on Tuesday, following clinical hold on Axalimogene filolisbac, its immunotherapy candidate for the treatment of HPV-associated cancers.

The company has completed a phase II study of Axalimogene filolisbac in recurrent/refractory cervical cancer. Axalimogene filolisbac is also being evaluated in 3 additional clinical trials for HPV-associated cervical cancer.

The other clinical trials of Axalimogene filolisbac are a phase 1/2 study in head and neck cancer; phase 2 study in head and neck cancer and two phase 2 studies in anal cancer.

The clinical hold was issued in response to Advaxis' recent submission of a safety report to the FDA, involving the death of one patient with end-stage cervical cancer who last received Axalimogene filolisbac in early 2013 in an investigator-initiated trial. The investigator ruled that the cause of death was due to progression of her cervical cancer.

The FDA has requested additional information to support a determination that Axalimogene filolisbac did not contribute to the patient's death. Advaxis expects the clinical hold to be resolved expeditiously and without significant interruption to its HPV clinical development program.

ADXS closed Tuesday's trading at $10.31, down 8.19%. In after hours, the stock cratered 25.80% to $7.65.

Akebia Therapeutics Inc. (AKBA) has reached agreement with both the FDA and EMA regarding key elements for its phase III trial of its lead product, Vadadustat, for patients with anemia related to non-dialysis dependent chronic kidney disease.

The trial, dubbed PRO2TECT, is expected to be launched later this year.

In addition, Akebia discussed with the FDA and EMA a parallel phase 3 program, known as the INNO2VATE program, for Vadadustat in patients with anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD). The company expects to formalize its phase 3 program in DD-CKD patients after presenting the results from its recently completed phase 2 study to both regulatory agencies.

AKBA closed Tuesday's trading at $10.34, up 2.48%.

Anavex Life Sciences Corp. (AVXL.OB) has announced a 1-for-4 reverse stock split to meet the conditions of a NASDAQ listing. The reverse stock split will reduce the authorized shares of common stock from 400 million prior to the split to 100 million after the reverse stock split, according to the company.

The company's lead product candidate is ANAVEX 2-73, an oral treatment for Alzheimer's, which is under a phase 2a trial.

The ongoing phase 2a trial, which has enrolled 32 patients, is a two-part trial - PART A, lasting up to 36 days for each patient, with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration and PART B, an open-label extension for an additional 52 weeks, with daily oral dosing so as to establish a longer drug effect.

Anavex expects to release topline data for PART A before the end of the year.

AVXL.OB closed Monday's trading at $1.45, down 23.48%.

Axovant Sciences Ltd. (AXON) has started a confirmatory global phase 3 study of its lead product candidate, RVT-101, in patients with mild-to-moderate Alzheimer's disease.

The trial, dubbed MINDSET, is designed to confirm the results of a 684-patient international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg RVT-101 demonstrated statistically significant improvements in cognition and function in mild-to-moderate Alzheimer's disease patients.

If all goes well, the company intends to submit a New Drug Application to FDA by the end of 2017.

The company went public as recently as June 11, 2015, priced at $15 per share. AXON closed Tuesday's trading at $13.21, down 1.20%.

Shares of Nu Skin Enterprises Inc. (NUS) were down over 10% in extended trading on Tuesday after the company forecast lower-than expected revenue for the third quarter.

The company estimates third-quarter revenue in a range of $570 to $573 million, which is well below the analysts' revenue expectation of $621.55 million.

"Third-quarter results were impacted by lower-than-expected sales of our new cosmetic oils in China during August and September, which may be a reflection of economic conditions in China," said Truman Hunt, president and CEO.

NUS closed Tuesday's trading at $46.57, up 1.57%. In after hours, the stock was down 10.89% at $41.50.

Robotic surgical arm maker Corindus Vascular Robotics Inc. (CVRS) has received FDA clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions performed via radial access.

The company's stock was uplisted to the NYSE MKT on May 29, 2015.

CVRS closed Tuesday's trading at $3.16, down 1.86%.

Sage Therapeutics (SAGE) has initiated dosing in a Phase 1 single ascending dose trial evaluating SAGE-217 in healthy volunteers. Initial top-line results from the study are expected in the first half of 2016.

SAGE-217 is being developed for high frequency seizures associated with select neurological disorders, including orphan epilepsies, and other GABAA dysfunction-related disorders, such as essential tremor.

SAGE closed Tuesday's trading at $41.98, down 7.68%.