NLNK Fails To Impress, TBPH Gets FDA Nod, It's A Make Or Break Month For TNXP

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) has a couple of catalysts to watch out for in the coming months.

The company's lead product candidate Zoptrex, a targeted cytotoxic therapy for endometrial cancer, is under a pivotal phase III study, which is on track for completion in Q3 2016. Top-line results from this study are anticipated by this year-end.

Another product candidate is Macrilen, an oral ghrelin agonist, which is being explored for Adult Growth Hormone Deficiency, in a phase III trial. This trial is also on track for completion in Q3 2016 and top-line results are expected as soon as possible following trial conclusion.

AEZS closed Monday's trading at $3.48, up 1.75%. In after hours, the stock was up another 12.07% to $3.90.

Aldeyra Therapeutics Inc.'s (ALDX) topical ocular NS2 has demonstrated activity comparable to standard-of-care topical ocular corticosteroids in reducing anterior chamber cell count in patients with active noninfectious anterior uveitis in a phase II trial.

Topical corticosteroids are often associated with ocular toxicity, including cataract formation and glaucoma (elevated intra-ocular pressure). The phase II data suggest that NS2 has the potential to reduce or replace corticosteroid use in noninfectious anterior uveitis, said the company.

Looking ahead, the company expects data from a phase II clinical trial of dermatologic NS2 for the treatment of ichthyosis in Sjögren-Larsson Syndrome in the third quarter of 2016.

ALDX closed Monday's trading at $6.20, up 0.16%.

Anthera Pharmaceuticals Inc. (ANTH) has completed enrollment in its phase II study of Blisibimod in IgA Nephropathy, called BRIGHT-SC, and a proof-of-concept efficacy analysis is expected to be conducted this quarter.

A phase III study of Blisibimod in systemic lupus erythematosus, dubbed CHABLIS-SC1, is underway, with results expected to be released later this year.

ANTH closed Monday's trading at $3.12, up 3.31%.

Shares of NewLink Genetics Corp. (NLNK) plunged over 30% in after-hours Monday, following the company's failure of phase III study of algenpantucel-L for patients with resected pancreatic cancer to achieve its primary endpoint.

In the study, dubbed IMPRESS, overall survival from time of randomization was 29.3 months for both groups combined. There was no statistically significant difference between the two groups. The median survival was 30.4 months and 27.3 months for the control and study groups, respectively. There was also no statistical difference for long-term survival. Three year survival was 41.4% and 42.1% and four year survival was 32.6% and 32.7% for the control and study groups, respectively, according to the company.

NLNK closed Monday's trading at $16.50, up 6.11%. In after hours, the stock was down 34% to $10.89.

Otonomy Inc. (OTIC) is all set to initiate a phase III trial for OTIPRIO in pediatric and adult patients with acute otitis externa during the second quarter of 2016. The topline results from this study are expected in the fourth quarter of 2016.

If the results are positive, the company expects to submit a supplemental New Drug Application for OTIPRIO to the FDA during the first half of 2017.

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 the U.S. in March 2016.

A phase II trial of OTIPRIO in pediatric patients with Acute Otitis Media with Tympanostomy Tubes is underway, with topline results expected in the second half of 2016.

OTIC closed Monday's trading at $12.26, up 0.99%.

Sorrento Therapeutics Inc. (SRNE) is exploring and evaluating strategic alternatives to maximize shareholder value.

The company does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the evaluation will result in any strategic alternative being announced or consummated.

SRNE closed Monday's trading 7.76% higher at $6.25.

TRACON Pharmaceuticals (TCON) has initiated a phase 1/2 clinical trial evaluating TRC105 in combination with Afinitor and Femara to treat patients with breast cancer prior to surgery.

The study is designed to enroll about 35 patients, and top-line data are expected in 2017.

TCON closed Monday's trading at $6.55, down 0.91%.

Theravance Biopharma Inc. (TBPH) has received FDA approval for expanded label of its antibiotic VIBATIV.

VIBATIV is already approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable, and for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

The expanded approval means VIBATIV can be used against concurrent Bacteremia in the 2 already approved indications.

TBPH closed Monday's trading at $18.63, up 3.79%.

Tonix Pharmaceuticals Holding Corp. (TNXP) expects to report top-line data from its phase II trial of TNX-102 SL for the management of PTSD, a serious mental health problem, dubbed AtEase, in the last half of this month.

Post-Traumatic Stress Disorder, or PTSD, affects approximately 8.4 million Americans and is a chronic and debilitating condition.

A placebo-controlled, 12-week phase III trial of TNX-102 SL in fibromyalgia, dubbed AFFIRM, is underway, with topline results anticipated in the third quarter of 2016.

TNXP closed Monday's trading at $2.17, up 11.86%.