ARLZ Gets FDA Nod, ACRX Scores Hat Trick, OTIC On Watch, No Relief For NVAX

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) was up more than 9% on Thursday, following positive results for ARX-04 in the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment, in its third phase III registration trial, dubbed SAP303.

The primary objective of the SAP303 trial was to study the safety of ARX-04 in the post-operative management of moderate-to-severe acute pain. According to the trial results, majority of patients - including the majority of higher-risk patients - did not experience any adverse events.

The company reported positive results from a phase III study, known as SAP301, which evaluated ARX-04 for the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery in September 2015. Positive results were reported from a phase III trial, dubbed SAP302, which assessed ARX-04 in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury last month.

Now that the results of all phase III studies are out, the company intends to submit a new drug application for ARX-04 for the treatment of moderate-to-severe acute pain in medically supervised settings with the FDA by the end of 2016.

ACRX closed Thursday's trading at $3.60, up 9.76%.

Shares of Aerie Pharmaceuticals Inc. (AERI) touched an all-time high of $34.69 on Thursday, following positive phase III results of its second glaucoma drug candidate Roclatan.

Roclatan is a fixed dose combination of Aerie's most advanced drug candidate Rhopressa and Latanoprost, a widely prescribed prostaglandin analog for glaucoma.

In the first phase III trial of Roclatan, known as Mercury 1, Roclatan demonstrated statistical superiority over Rhopressa and Latanoprost.

Another phase III trial of Roclatan, named Mercury 2, is underway, and topline data readout from this trial is expected in the second quarter of 2017.

The company filed its NDA for Rhopressa last week.

AERI touched an all-time high of $34.69 on Thursday, before closing the day's trading at $30.61, up 44.87%.

Amgen's (AMGN) global phase II trial of Erenumab has demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine.

The study included 667 patients who were randomized to receive either subcutaneous placebo or subcutaneous Erenumab 70 mg once or 140 mg once a month. At week 12, there was a reduction of 50 percent or more in number of monthly migraine days in 40 percent and 41 percent (70 mg and 140 mg doses, respectively) of individuals in the Erenumab groups compared to just 24 percent of those receiving placebo.

Results from phase III studies investigating Erenumab in episodic migraine are expected later this year.

Erenumab is being co-developed by Amgen and Novartis (NVS). Amgen retains commercialization rights to Erenumab in the U.S., Canada and Japan while Novartis holds rights in Europe and rest of world.

AMGN closed Thursday's trading at $172.64, up 1.47%.

The FDA has approved Aralez Pharmaceuticals Inc.'s (ARLZ) once-daily YOSPRALA for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

YOSPRALA is the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the U.S.

Daily aspirin is a standard of care for secondary cardiovascular event prevention, but gastrointestinal symptoms are often cited as the reason patients stop taking this important therapy. YOSPRALA is designed to support both cardio- and gastro-protection for at-risk patients.

ARLZ closed Thursday's trading 5.13% higher at $5.74.

BioMarin Pharmaceutical Inc.'s (BMRN) Marketing Authorization Application for Brineura to treat children with CLN2 disease, a form of Batten disease, has been accepted for review by the European Medicines Agency.

Accordingly, the review process has been started, with the opinion of EMA's Committee for Human Medicinal Products (CHMP), and a decision from the European Commission anticipated by the third quarter of 2017.

In the U.S., the NDA for Brineura is under FDA review, and a decision is expected on April 27, 2017.

BMRN closed Thursday's trading at $95.38, up 0.08%.

Cara Therapeutics Inc. (CARA) has initiated a phase 2b trial of an oral tablet formulation of CR845 for the treatment of pain associated with osteoarthritis.

The study is designed to evaluate three tablet strengths of CR845, 1.0 mg, 2.5 mg and 5.0 mg, dosed twice a day over an eight-week treatment period in approximately 330 osteoarthritis patients experiencing moderate-to-severe pain.

The company expects to report top-line data from this trial during the first half of 2017.

CARA closed Thursday's trading at $6.23, up 2.30%.

Merck, (MRK) in partnership with Pfizer Inc. (PFE), on Thursday announced that a phase III study of Ertugliflozin, an investigational oral drug for the treatment of patients with type 2 diabetes, met its primary endpoint.

In the study, dubbed VERTIS SITA2, 5 mg and 15 mg daily doses of Ertugliflozin showed significantly greater reductions in A1C* of 0.69 percent and 0.76 percent, respectively, compared with placebo, when added to patients on a background of JANUVIA (100 mg/day) and stable Metformin (=1500 mg/day).

*A1C is an average measure of blood glucose over the past two to three months.

MRK closed Thursday's trading at $62.38, up 1.68%.

Shares of Novavax Inc. (NVAX) plunged more than 83% in extended trading on Thursday, following the failure of its phase III trial of respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate.

In the trial, dubbed Resolve, the company's respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate ((RSV F Vaccine) did not demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms.

The secondary objective of demonstrating efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD) was also not achieved.

NVAX closed Thursday's trading at $8.34, up 0.36%. In after hours, the stock was down 83.21% to $1.40.

Otonomy Inc. (OTIC) has successfully completed an open-label phase 3b clinical trial of OTIPRIO in 501 pediatric patients with a history of otitis media requiring tympanostomy tube placement surgery.

Otiprio was approved by the FDA last December for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement, and was commercially launched in March of this year. The drug has generated sales of $89 thousand year-to-date.

The phase 3b trial of OTIPRIO involved a broader pediatric patient population than the previous phase III trials by including patients undergoing common concurrent surgeries and patients without bilateral effusion on the day of surgery.

OTIC closed Thursday's trading at $18.00, up 1.24%.

TapImmune Inc. (TPIV.OB) is all set to implement a 1-for-12 reverse stock split of its common stock in preparation for its proposed uplisting to the NASDAQ Capital Market.

The reverse stock split will become effective on September 16, 2016.

TPIV.OB closed Thursday's trading at $0.43, down 1.15%.