ARDM Awaits Data In Q4, FDA Clears TCMD Device, Newfound Interest For GLMD, GALT

(RTTNews) - Aradigm Corp.'s (ARDM) two phase III studies of its investigational drug Pulmaquin in patients with non-cystic fibrosis bronchiectasis are proceeding as planned.

The last patient has completed the final dosing visit in the two trials, dubbed ORBIT-3 and ORBIT-4. The top-line data from the two trials are expected to be available in the fourth quarter of this year.

ARDM closed Thursday's trading at $6.25, up 19.96%.

Galmed Pharmaceuticals Ltd. (GLMD) was up over 18% on Thursday, following an investigator-initiated clinical trial agreement with the University of California, San Diego to assess its product candidate Aramchol in a juvenile population with nonalcoholic fatty liver disease.

Nonalcoholic fatty liver disease, or NAFLD, is one of the most common liver disorders, and Non-Alcoholic Steato-Hepatitis (NASH) is a more severe form of NAFLD.

As per the agreement terms, a phase I/IIa trial of Aramchol in a juvenile population with NAFLD, dubbed ARTISAN Study, will be initiated. The ARTISAN Study marks the third investigator-initiated clinical trial, and the other two being ARREST and ARRIVE.

The ARREST study is a phase IIb study of Aramchol to treat NASH patients that also suffer from obesity and insulin resistance. The ARRIVE study is a phase II study of Aramchol for HIV-associated lipodystrophy and nonalcoholic fatty liver disease.

There has been considerable interest in NASH stocks ever since Allergan plc (AGN) acquired Tobira Therapeutics Inc. (TBRA) and privately-held Akarna Therapeutics Ltd. on September 20, 2016 to strengthen its research and development position in the field of nonalcoholic steatohepatitis.

GLMD closed Thursday's trading at $5.50, up 18.53%. The stock has gained nearly 50% in the last 3 days.

Galectin Therapeutics Inc. (GALT), which is also developing drug candidates for NASH, has gained nearly 72% in the last 3 days. The stock closed Thursday's trading 10.38% higher at $2.87.

Shares of Intellipharmaceutics International Inc. (IPCI) (I.TO) were up more than 23% on Tuesday. The company said it is not aware of any corporate developments that would cause a spike in the share price.

As previously reported, Intellipharmaceutics plans to file its NDA for Rexista Oxycodone XR, which is bioequivalent to Oxycontin, in the fiscal fourth quarter ending November 30, 2016.

Rexista Oxycodone XR is intended for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

IPCI closed Thursday's trading at $2.29, up 23.43%.

Tactile Systems Technology Inc. (TCMD) has received FDA clearance for the Flexitouch System in treating lymphedema of the head and neck, a common consequence of head and neck cancer.

The company may commercially launch Flexitouch System for the treatment of head and neck lymphedema in the first half of 2017.

Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. An estimated three million and five million people in the United States are affected by this chronic disease.

TCMD closed Thursday's trading at $19.20, up 0.21%.

Teva Pharmaceutical Industries Ltd.'s (TEVA) second phase III registration trial of SD-809 in tardive dyskinesia has also achieved the primary endpoint. In the trial, dubbed AIM-TD study, SD-809 demonstrated a statistically significant improvement in Abnormal Involuntary Movement Scale score.

Tardive dyskinesia is a neurological disorder that causes repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities.

The results of the first phase III trial of SD-809, known as ARM-TD trial, were announced in June 2015. Teva expects to make a regulatory submission to the FDA by the end of 2016.

TEVA closed Thursday's trading at $51.23, up 1.49%.