INGN Lifts Outlook, BCLI Awaits DSMB Review, TRVN To Report Data Next Month

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) on Tuesday announced that the independent Data and Safety Monitoring Board for its pivotal phase III trial of Zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer will complete a pre-specified second interim efficacy and safety analysis of the compound in early October 2015.

The trial, dubbed ZoptEC, reached the 500-patient target in June of this year.

AEZS closed Tuesday's trading at $0.17, up 5.95%.

Aldeyra Therapeutics Inc. (ALDX), which filed a Clinical Trial Authorization with Health Canada for a phase IIa study of NS2 ophthalmic drops in patients with allergic conjunctivitis in late July 2015, expects enrollment in the trial to be completed in 2016.

The company expects its ongoing phase II clinical trial of NS2 in Sjögren-Larsson Syndrome to be fully enrolled by the end of the first quarter of 2016, and its ongoing phase II clinical trial of NS2 in non-infectious anterior uveitis to complete enrollment in the second quarter of 2016.

ALDX closed Tuesday's trading at $8.34, up 2.71%.

BrainStorm Cell Therapeutics Inc.'s (BCLI) ongoing phase II clinical trial of NurOwn in amyotrophic lateral sclerosis has achieved the targeted enrollment of 48 subjects.

In February 2015, the Data Safety and Monitoring Board overseeing the trial completed its first safety review of the trial, and did not find any lab abnormalities, adverse events or significant protocol deviations that would be cause for concern. A second and final DSMB review is planned the fourth quarter of 2015.

BCLI closed Tuesday's trading at $2.91, up 0.69%.

Clovis Oncology Inc. (CLVS) has entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate a novel combination therapy of Genentech's investigational cancer immunotherapy Atezolizumab and Clovis' Rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer.

Earlier this month, Clovis submitted regulatory filings to the FDA and European Medicines Agency seeking approval of Rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

CLVS closed Tuesday's trading at $78.47, down 1.68%. In after hours, the stock was up 0.23% at $78.65.

Medical technology company Inogen Inc. (INGN), which reported record results for the second quarter of 2015, has raised its financial outlook for full year-2015.

The company's net income increased to $3.5 million or $0.17 per share on revenue of $44.0 million in the second quarter ended June 30, 2015. This compares with net income of $2.3 million or $0.11 per share and revenue of $30.4 million in the year-ago quarter.

Looking ahead to full year 2015, the company now expects net income to be in the range of $8.5 million to $10 million, up from its prior forecast range of $8 million to $9.5 million.

The company has also revised its revenue forecast for 2015 to a range of $145 million to $149 million from its previous revenue expectation of $133 million to $137 million.

INGN closed Tuesday's trading at $42.60, down 1.50%. In after-hours, the stock was up 3.73% at $44.19.

La Jolla Pharmaceutical Co. (LJPC) has received clearance from the FDA to begin a phase I study of LJPC-401.

The company is developing LJPC-401 for the treatment of iron overload, which occurs as a result of diseases such as hereditary hemochromatosis and beta thalassemia. The preliminary results from the phase I clinical trial of LJPC-401 are expected by the end of 2015.

LJPC closed Tuesday's trading at $24.45, down 5.38%.

Trevena Inc. (TRVN), which has completed enrollment in its phase IIb study of TRV130 for acute postoperative pain following soft tissue surgery, expects to report key results related to efficacy, safety and tolerability in September 2015.

The primary endpoint of the study is the time-weighted average change from baseline in the numeric pain rating scale scores over the 24-hour assessment interval for TRV130 compared to placebo with pre-specified secondary comparisons to morphine.

The company's phase 2b trial of TRV027 in acute heart failure patients, which is now targeted to enroll 620 patients from the initial target of 500 patients, is continuing to advance. The top-line data are now expected in the second quarter of 2016.

TRVN closed Tuesday's trading at $5.90, down 3.44%.

Zafgen Inc. (ZFGN), which has completed enrollment in a phase III trial of Beloranib in Prader-Willi syndrome patients, expects to release six-month randomized top-line results early in the first quarter of 2016.

A phase 2b clinical trial of Beloranib in patients with severe obesity complicated by type 2 diabetes is underway, and 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 Tuesday's trading at $37.52, down 1.34%. In after hours, the stock was up 9.99% at $41.27.