RVNC Works It Out, ONCE Awaits Data, AKBA, VTAE Make Big Moves, TTPH Doused

(RTTNews) - AcelRx Pharmaceuticals Inc.'s (ACRX) phase III trial of ARX-04 (sufentanil sublingual tablet, 30 mcg) in patients with moderate-to-severe acute pain following ambulatory abdominal surgery has met primary and secondary endpoints.

According to the study results, patients receiving ARX-04, administered via a disposable, pre-filled, single-dose applicator (SDA), experienced significantly greater pain reduction compared to placebo.

The company expects to initiate a study of ARX-04 in emergency room patients this year.

ACRX closed Wednesday's trading at $3.93, down 3.91%.

Aduro Biotech Inc. (ADRO) has entered into a clinical trial agreement with Incyte Corp. (INCY) to evaluate the safety, tolerability and preliminary efficacy of Aduro's lead drug candidate CRS-207, in combination with Incyte's investigational cancer immunotherapy Epacadostat in patients with ovarian cancer.

Accordingly, the companies intend to initiate a phase I/II trial in early 2016. The study, which will be funded equally between the two companies, is designed to test combinations of CRS-207 with two dose levels of Epacadostat in dose escalation and then will expand to a phase II evaluating the combination at the optimal dose level compared to CRS-207 alone based on safety and tumor biomarkers.

The study plans to enroll up to 40 patients in phase I and up to 86 patients in phase II with platinum-resistant ovarian, fallopian or peritoneal cancers.

Aduro went public on April 15, 2015, priced at $17 per share. The stock closed Wednesday's trading at $19.33, up 0.47%.

Shares of Akebia Therapeutics Inc. (AKBA) zoomed more than 45% on Wednesday as investors welcomed the positive top-line results from its phase II study of Vadadustat in dialysis patients with anemia related to chronic kidney disease.

According to the trial results, treatment with Vadadustat successfully maintained mean hemoglobin levels following conversion from recombinant erythropoiesis-stimulating agent (rESA) therapy. Vadadustat also demonstrated a favorable safety profile with once daily and three times per week dosing.

AKBA closed Wednesday's trading 45.45% higher at $11.36.

Egalet Corp. (EGLT) has commercially launched in the United States OXAYDO, a product licensed from Acura Pharmaceuticals Inc. (ACUR). OXAYDO is indicated for the treatment of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Under the terms of the agreement, Egalet has to pay a milestone payment of $2.5 million upon the first commercial sale of OXAYDO in the U.S., which Acura currently expects to receive in the fourth quarter of 2015, and an additional one-time payment of $12.5 million when annual world-wide net sales of OXAYDO first reach $150 million in a calendar year.

EGLT closed Wednesday's trading at $14.19, up 5.19%.

Medgenics Inc. (MDGN) has acquired neuroFix Therapeutics LLC, bringing into its fold NFC-1, which is a phase 2/3-ready compound for the treatment of Attention Deficit Hyperactivity Disorder.

Medgenics acquired all outstanding shares of neuroFix for upfront consideration of $2 million cash, a series of performance-based milestone payments and sales royalties.

MDGN closed Wednesday's trading 1.97% higher at $7.24.

Revance Therapeutics Inc. (RVNC) has initiated a phase II clinical trial of Botulinum Toxin Type A Topical Gel, now referred to as RTT150, to treat axillary hyperhidrosisInterim (excessive underarm sweating).

A total of approximately 60 adult patients at multiple sites in the United States are expected to be enrolled in the study - with interim data scheduled for release by year end 2015.

RVNC closed Wednesday's trading at $30.03, down 1.48%.

The New Drug Application for Alectinib, filed by Roche's subsidiary Genentech, has been accepted for priority review by the FDA.

Alectinib is an oral investigational anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib).

The FDA's decision on Alectinib is scheduled for March 4, 2016.

Alectinib was granted Breakthrough Therapy Designation by the FDA in June 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

Spark Therapeutics Inc. (ONCE) expects to release top-line results from its phase III trial of its lead program, SPK-RPE65, for the treatment of RPE65-mediated inherited retinal dystrophies, next month.

An update on the SPK-RPE65 program, including a review of the final phase III Statistical Analysis Plan (SAP) will be presented during a conference call scheduled for September 10, 2015.

ONCE closed Wednesday's trading at $45.11, down 2%. In after hours, the stock shed another 1.35% to $44.50.

Shares of Tandem Diabetes Care Inc. (TNDM) were up more than 9% on Wednesday, following FDA approval of the company's t:slim G4 Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring integration, for use by people 12 years of age or older who use insulin.

The t:slim G4 Insulin Pump combines features of the t:slim Insulin Pump and Dexcom G4 PLATINUM CGM System into a single device that is simple to use. Shipments of the newly approved device are expected to begin in October 2015.

TNDM closed Wednesday's trading at $13.00, up 9.70%.

TG Therapeutics Inc. (TGTX) has initiated a phase I/II clinical study of TGR-1202 and TG-1101 in combination with Merck's skin cancer drug Keytruda (pembrolizumab) in patients with relapsed or refractory Chronic Lymphocytic Leukemia.

The phase I part of the study will evaluate the safety, tolerability, and appropriate dose of pembrolizumab when combined with TGR-1202 and TG-1101 in patients with advanced CLL. The phase II part of the study will further evaluate the safety and effectiveness of the triple combination at the recommended phase II dose.

TGTX closed Wednesday's trading at $11.01, down 3.84%.

Shares of Tetraphase Pharmaceuticals Inc. (TTPH) plunged more than 78% on Wednesday as the company's phase III clinical trial of Eravacycline for the treatment of complicated urinary tract infections, dubbed IGNITE2, failed to meet its primary endpoint.

In a phase III trial, which evaluated Eravacyclinein complicated intra-abdominal infections, dubbed IGNITE1, the results of which were announced last December, Eravacycline achieved the primary endpoint.

TTPH closed Wednesday's trading at $9.49, down 78.81%.

Shares of Vitae Pharmaceuticals Inc. (VTAE) spiked more than 89% on Wednesday following positive top-line results from the company's phase I single ascending dose clinical study of VTP-43742 in autoimmune disorders.

VTP-43742 is being developed for the treatment of a range of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and irritable bowel disease (IBD), as well as numerous orphan diseases.

The phase I trial that evaluated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of single oral doses of VTP-43742 in 53 healthy human volunteers, demonstrated that VTP-43742 was safe and generally well tolerated at all dose levels across a 60-fold dose range.

A phase I multiple ascending dose clinical trial of VTP-43742, which includes both healthy human volunteers and patients with moderate to severe psoriasis, is underway. The company plans to begin dosing psoriatic patients in the second half of 2015, with top-line clinical efficacy results expected by the end of 2015.

VTAE closed Wednesday's trading 89.16% higher at $15.00.

Zafgen Inc. (ZFGN) has completed enrollment in a phase IIb trial of Beloranib in patients with both severe obesity and type 2 diabetes. The trial enrolled 152 patients across 16 sites in Australia.

The trial aims to demonstrate efficacy and safety over a 12 month period, with an interim six-month analysis. The primary efficacy endpoint is change in total body weight at six months of randomized treatment. Key secondary endpoints include changes in glycemic control, lipid parameters and inflammatory markers.

The company remains on track to release six-month interim data in a subset of 95 patients in late 2015 or very early 2016.

ZFGN closed Wednesday's trading at $38.26, down 1.21%.