AQXP Leads, ESPR To Meet With FDA, RPTP On Watch, CLSN Heating Up

(RTTNews) - Pet therapeutics company Aratana Therapeutics Inc. (PETX) is planning to seek approval for a couple of its drug candidates in 2016.

AT-002 in dogs with reduced appetite from a variety of causes and AT-003 (extended-release bupivacaine liposome injectable suspension) in dogs with post-operative pain are the drug candidates for which the company anticipates submitting an administrative New Animal Drug Application in 2016.

PETX closed Thursday's trading at $16.89, down 4.25%.

Shares of Aquinox Pharmaceuticals Inc. (AQXP) were up more than 13% in extended trading on Thursday, following encouraging secondary endpoint results from a phase II trial of AQX-1125 in patients with bladder pain syndrome/interstitial cystitis (BPS/IC).

While the trial, dubbed LEADERSHIP, did not reach statistical significance in its primary endpoint of reduction in pain, as already reported in June of this year, there has been a clinically meaningful improvement in pain in a high proportion of patients treated with AQX-1125 compared to placebo.

According to the company, positive results from secondary endpoints included a statistically significant 1.3 point greater reduction over placebo on maximum daily pain at six weeks and a statistically significant 4.4 point greater reduction over placebo on the O'Leary Sant Symptom Scale at six weeks compared to placebo.

A phase II trial of AQX-1125 in atopic dermatitis, dubbed KINSHIP, is underway, and top line data from this trial are now expected in Q4 2015, earlier than previously guided.

AQXP closed Thursday's trading at $1.79, up 1.70%. In after hours, the stock was up another 13.41% to $2.03.

Shares of Celsion Corp. (CLSN) rose more than 5% on Thursday after the company announced that updated data from HEAT study of ThermoDox in primary liver cancer showed a statistically significant improvement in overall survival, translating to a greater than two-year survival benefit following treatment with ThermoDox plus optimized radiofrequency ablation.

A phase III study of ThermoDox in combination with optimized radiofrequency ablation in newly diagnosed hepatocellular carcinoma patients, dubbed OPTIMA Study, is currently enrolling patients in 12 countries globally.

CLSN closed Thursday's trading at $2.34, up 5.90%. In after-hours, the stock was up 2.99% at $2.41.

Esperion Therapeutics Inc. (ESPR) is scheduled to have an End-of-Phase 2 meeting with the FDA in the first half of August to discuss the planned phase 3 program for ETC-1002 for the treatment of patients with hyperlipidemia and mixed dyslipidemia.

The company plans to initiate a comprehensive phase III clinical development program for ETC-1002 in Q4, 2015.

Esperion expects that its current cash resources will be approximately $290 million at December 31, 2015, which will be sufficient to fund the company through 2018 and the expected approval of ETC-1002.

ESPR closed Thursday's trading at $55.61, down 7.75%.

Flexion Therapeutics Inc. (FLXN) now expects to report topline data from a phase III trial of FX006 in patients with moderate to severe osteoarthritis knee pain in the first quarter of 2016, ahead of schedule.

As previously announced, the topline clinical data readout from the company's ongoing phase 2b clinical trial of FX006 is expected in September 2015, approximately two months ahead of schedule.

FLXN closed Thursday's trading at $22.54, down 5.81%.

Raptor Pharmaceutical Corp. (RPTP) has a few catalysts to watch out for in the reminder of this year.

The FDA decision related to the label expansion for PROCYSBI to include nephropathic cystinosis patients aged 2-6 years is set for August 14, 2015. PROCYSBI is already approved in the U.S. for the management of nephropathic cystinosis in adults and children ages 6 years and older. The global net product sales for PROCYSBI were $69.5 million in 2014.

A phase 2b trial of RP103 for pediatric non-alcoholic steatohepatitis (NASH) is underway, and data is expected in the third quarter of 2015.

An update on the regulatory pathway in Huntington's disease, along with data from the 36-month time-point for a phase 2/3 study of RP103 in Huntington's disease is expected in the fourth quarter of 2015.

RPTP closed Thursday's trading at $13.75, down 3.71%.

Revance Therapeutics Inc. (RVNC) expects safety, efficacy and 24-week duration results from a phase II study comparing RT002 Botulinum Toxin Type A to Botox Cosmetic for the treatment of glabellar (frown) Lines to be reported before this year end.

In the third quarter, the company expects to initiate a US phase 2 dose-escalating study to evaluate the safety and preliminary efficacy of RT002 for the treatment of cervical dystonia, with interim data scheduled for release before the end of 2015.

RVNC closed Thursday's trading at $31.21, down 4.41%.