CERC Data Due Dec., SAMURAI Brings Cheer To CLCD, TNXP Slumps As Study Fails

(RTTNews) - Aerie Pharmaceuticals Inc. (AERI) has submitted its New Drug Application for Rhopressa 0.02%, a novel once-daily eye drop designed to lower intraocular pressure in patients with glaucoma or ocular hypertension.

Another major event awaited by the company this month is the topline 90-day efficacy readout from the first phase III trial of its investigational drug Roclatan, known as Mercury 1.

Mercury 1 is testing Roclatan, a novel once-daily, quadruple-action eye drop for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

AERI closed Tuesday's trading at $19.57, down 0.15%.

Aeolus Pharmaceuticals Inc.'s (AOLS.OB) investigational compound AEOL 10150 doubled survival at 28 days after exposure to lethal sulfur mustard gas in an animal study. The median survival time for animals treated with AEOL 10150 was 4.5 times greater than untreated animals, according to the results.

AEOL 10150 is being developed as a treatment for chemical vesicant and nerve gas exposure under funding by the National Institutes of Health's Countermeasures Against Chemical Threats ("CounterACT") program.

Aeolus is also developing AEOL 10150 as a treatment for the lung syndrome of Acute Radiation Syndrome under a five year contract with the Biomedical Advanced Research and Development Authority (BARDA).

AOLS.OB closed Tuesday's trading at $0.20, unchanged from the previous day's close.

Aquinox Pharmaceuticals Inc. (AQXP) has initiated dosing in a phase III clinical trial of AQX-1125 for the treatment of interstitial cystitis/bladder pain syndrome.

The trial, dubbed LEADERSHIP 301, will enroll a minimum of 300 female patients and up to 300 male subjects at clinical research centers in Canada, the United States and Europe and will investigate 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.

Top-line data from the LEADERSHIP 301 trial is anticipated in the fourth quarter of 2017.

AQXP closed Tuesday's trading at $11.86, down 2.31%.

The FDA decision on BioMarin Pharmaceutical Inc.'s (BMRN) Biologics License Application for Brineura for the treatment of CLN2 disease, a form of Batten disease, has been extended by three months to April 27, 2017.

The decision date has been extended following submission of additional data by the company upon FDA request. The FDA is also planning to hold an advisory committee meeting at a date to be confirmed per their usual practice of notification in the Federal Register.

BMRN closed Tuesday's trading at $95.59, down 0.15%.

Cerecor Inc. (CERC) has completed patient enrolment in its phase II clinical trial of CERC-501 for smoking cessation.

The primary objective of the study is to evaluate the effect of CERC-501 compared to placebo on symptoms of tobacco withdrawal and smoking behaviors. The company expects to report top-line data from this trial in the beginning of December 2016.

CERC closed Tuesday's trading at $3.99, up 2.05%.

Shares of CoLucid Pharmaceuticals Inc. (CLCD) leapt as much as 131% on Tuesday, following positive results from its phase III pivotal trial of Lasmiditan in migraine, dubbed SAMURAI.

In the SAMURAI trial, the safety and efficacy of Lasmiditan 100 mg and 200 mg were evaluated in up to 2,231 migraine patients compared to placebo two hours after dosing.

According to the trial results, both the primary endpoint of freedom from migraine headache pain and the key secondary endpoint of freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia) were achieved.

CLCD touched a new high of $24.65 on Tuesday before closing the day's trading at $23.83, up 123.55%.

Exelixis Inc.'s (EXEL) phase III trial of investigational drug Cabozantinib in patients with advanced hepatocellular carcinoma, dubbed CELESTIAL, is all set to continue without modifications, following the first planned interim analysis by an Independent Data Monitoring Committee.

The CELESTIAL trial is evaluating Cabozantinib against placebo in patients with advanced hepatocellular carcinoma who have been previously treated with Sorafenib.

A second interim analysis will be conducted once 75 percent of events have been observed.

EXEL closed Tuesday's trading 4.68% higher at $12.08.

Shares of Karyopharm Therapeutics Inc. (KPTI) fell as much as 18% on Tuesday despite positive data from its phase 2b study evaluating the activity of Selinexor in multiple myeloma.

In the study, dubbed STORM, Selinexor achieved promising response rates in patients with multiple myeloma, including 20.8% in quad-refractory and 20.0% in penta-refractory disease.

The company is expanding the phase 2b STORM study to include approximately 120 additional patients with penta-refractory myeloma to support seeking accelerated approval.

The company plans to initiate a pivotal randomized phase III study, known as BOSTON, in early 2017 to evaluate Selinexor in combination with Bortezomib and Dexamethasone versus Bortezomib and Dexamethasone in previously treated myeloma patients.

KPTI closed Tuesday's trading at $8.97, down 15.54%.

Shares of Navidea Biopharmaceuticals Inc. (NAVB) were up over 135% on Tuesday, following the Letter of Intent, which the company entered into with Cardinal Health Inc, for the sale of Lymphoseek in North America.

Navidea's Lymphoseek is approved by the FDA to help identify lymph nodes closest to a primary tumor in patients with breast cancer or melanoma, and to help determine the extent of head and neck cancer in the body.

Under the terms of the Letter of Intent, Navidea would receive $80 million at closing, with future consideration tied to annual sales of the Lymphoseek product and certain sales-based milestones. Total consideration to Navidea would be capped at $310 million.

NAVB closed Tuesday's trading at $0.80, up 135.57%.

Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) slumped more than 57% on Tuesday as the company's phase III trial of TNX-102 SL in patients with fibromyalgia failed to meet the primary endpoint.

Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue, and disability.

The study, dubbed AFFIRM, did not achieve statistical significance in the primary efficacy endpoint namely, the proportion of patients who reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period. TNX-102 SL was generally well tolerated, and no new safety signals were observed.

TNXP closed Tuesday's trading at $0.92, down 57.69%.

Zynerba Pharmaceuticals Inc. (ZYNE) has initiated a phase II clinical trial of ZYN002 CBD Gel for the treatment of osteoarthritis.

The study, dubbed STOP, will enroll up to 300 patients, and topline results are expected in the first half of 2017.

ZYNE closed Tuesday's trading at $9.45, up 11.57%.