EGLT Gets FDA Panel Nod, NXTM On A High, BDSI Ahead Of Schedule

(RTTNews) - Shares of Aquinox Pharmaceuticals Inc. (AQXP) were down over 14% in extended trading on Thursday, following wider-than-expected loss in the second quarter ending June 30, 2016.

The net loss for the second quarter of 2016 widened to $10.9 million or $0.63 per share from $4.8 million or $0.44 per share in the second quarter of 2015. Analysts polled by Thomson Reuters expected the company to report a loss of $0.41 per share.

The company attributed the wider loss to increased operating expenditures related to the initiation of its LEADERSHIP 301 clinical trial.

The LEADERSHIP 301 clinical trial is a phase III study investigating the ability of 200 mg and 100 mg oral, once daily AQX-1125 to reduce bladder pain in patients with moderate to severe interstitial cystitis/bladder pain syndrome (IC/BPS).

AQXP closed Thursday's trading at $9.61, up 7.13%. In after hours, the stock was down 14.67% to $8.20.

Arbutus Biopharma Corp. (ABUS) has a couple of catalysts lined up for the coming months.

The company is on track to report single dose HBsAg reduction data from a phase II trial of ARB-1467 in HBV-infected patients in the third quarter, and HBsAg reduction data from the multiple dose portion of the phase II trial testing ARB-1467 in HBV-infected patients in the fourth quarter of this year.

ABUS closed Thursday's trading at $4.37, down 0.68%.

BioDelivery Sciences International Inc. (BDSI) now expects to report topline results from its phase 2b study of Clonidine Topical Gel in the treatment of pain associated with painful diabetic neuropathy by the end of this year, six to eight weeks ahead of schedule.

If all goes well as planned, the company expects to commence a confirmatory phase 3 study in early 2017.

BDSI closed Thursday's trading at $2.45, down 0.81%.

Shares of Egalet Corp. (EGLT) were up over 27% in after-hours on Thursday, following a positive vote from the FDA panel for the company's abuse-deterrent ARYMO ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The panel voted 18 to 1 to recommend approval of ARYMO ER. The FDA's final decision is slated for October 14, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

EGLT was up 27.30% to $9.70 in extended trading on Thursday.

Momenta Pharmaceuticals Inc. (MNTA) has decided to discontinue further enrollment in its Phase II trial evaluating Necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer based on the recommendation of the independent Data Safety Monitoring Board.

An interim futility analysis has revealed that Necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment.

MNTA closed Thursday's trading at $11.16, down 4.94%.

Shares of Nxstage Medical Inc. (NXTM) touched a new 52-week high, following another strong quarter of growth and improving profitability and an upbeat outlook.

Net loss attributable to the company improved to $1.7 million or $0.03 per share on revenue of $92.2 million in the second quarter of 2016. This compared with a net loss of $5.3 million or $0.08 per share and revenue of revenue of $80.3 million in the second quarter of 2015.

The company now expects full-year revenue for 2016 to be in the range of $360 to $365 million, versus its previously increased guidance for revenue to be at the high end of its range of $355 to $360 million.

NXTM touched a new 52-week high of $24.05 on Thursday, before closing the day's trading at $ 23.84, up 8.34%.

Otonomy Inc. (OTIC) expects to report topline results from its phase III registration trial of OTIPRIO in pediatric and adult patient with acute otitis externa in the fourth quarter of 2016. If all goes well as planned, a supplemental New Drug Application is slated to be submitted in the first half of 2017.

OTIPRIO received FDA approval last December for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

The company expects to report results from an open label phase IIIb trial of OTIPRIO in expanded population of pediatric patients undergoing tympanostomy tube placement surgery this quarter.

A phase II clinical trial evaluating a single administration of OTIPRIO for the treatment of pediatric patients with Acute Otitis Media with Tympanostomy Tubes is underway, with results anticipated next quarter.

OTIC closed Thursday's trading at $15.22, up 3.61%.