BMY To Face FDA, XON Springs A Surprise, AERI Awaits Rocket To Deliver

(RTTNews) - Aerie Pharmaceuticals Inc. (AERI) expects to report three-month efficacy data from its phase 3 registration trial, dubbed Rocket 1, which is intended to demonstrate non-inferiority of IOP (intraocular pressure) lowering for the company's investigational product Rhopressa compared to FDA-approved Timolol, by mid-second quarter of 2015.

AERI closed Monday's trading 2.88% higher at $28.93.

Aquinox Pharmaceuticals Inc. (AQXP) has completed enrollment in its phase II trial of AQX-1125 for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC).

The study, dubbed LEADERSHIP trial, is investigating the ability of AQX-1125 to reduce pain in 68 female patients with BPS/IC. The company expects reporting of top line data near mid-year.

AQXP closed Monday's trading 4.86% higher at $10.22.

Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection has been accepted for review by the FDA. The regulatory agency's decision is slated for October 28, 2015.

The initial FDA approval for Yervoy was in 2011 for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.

BMY closed Monday's trading at $62.30, up 2.27%.

Intrexon Corporation (XON) was up more than 6% in extended trading after the company reported a surprise profit and better-than-expected revenue for the fourth quarter ended December 31, 2014.

The company reported a net income of $18.8 million or $0.18 per share on revenue of $31.1 million in Q4, 2014. Analysts polled by Thomson Reuters were expecting a loss of $0.16 per share and revenue of $26.11 million. Net loss was $12.2 million or $0.13 per share on revenue of $7.1 million in Q4, 2013.

XON closed Monday's trading at $40.22, down 2.05%. In after-hours, the stock was up 6.59% at $42.87.

IGI Laboratories Inc. (IG) has reported better-than expected results for the fourth quarter and full year ended December 31, 2014.

The company now has 22 ANDAs pending approval by the FDA. For this year, IG Labs expect to file at least twenty more ANDAs.

IG touched a new high of $12.05 on Monday before closing the day's trading at $11.45.

NeoStem Inc. (NBS) expects randomization of the first patient for its phase 3 trial of its drug candidate NBS20 in stage III recurrent and stage IV metastatic melanoma patients in the second quarter of 2015.

The company is also planning to release one-year data from its phase 2 trial of NBS10 for acute myocardial infarction on March 15, 2015 at the Annual Scientific Sessions of the American College of Cardiology.

NBS closed Monday's trading at $3.80, up 1.06%.

Portola Pharmaceuticals (PTLA) touched a new high on Monday after announcing that the first part of its phase III trial, dubbed ANNEXA, evaluating the safety and efficacy of its drug candidate Andexanet alfa with the Factor Xa inhibitor XARELTO in healthy volunteers met all primary and secondary endpoints with high statistical significance compared with placebo.

In the first part of the ANNEXA-R study, 41 healthy volunteers were given XARELTO 20 mg once daily for four days to steady state. They were then randomized to receive either andexanet alfa administered as an 800 mg IV bolus or placebo.

According to the trial results, Andexanet alfa reduced the anti-Factor Xa activity of XARELTO from baseline to nadir by more than 90 percent, a highly significant difference.

PTLA closed Monday's trading 7.04% higher at $40.76. In after hours, the stock was up another 3.29% at $42.10.