CLRB Gets A Breather, DRRX To PERSIST, ICPT Wins FDA Panel Vote Hands Down

(RTTNews) - Cellectar Biosciences Inc.'s (CLRB) request for continued listing of its common stock on the NASDAQ Capital Market has been accepted by the NASDAQ Listing Qualifications Panel.

The company's continued listing on NASDAQ is subject to, among other things, becoming compliant with the minimum $2.5 million stockholders' equity requirement by May 16, 2016. Cellectar must also provide the panel with updated information regarding its ability to maintain compliance for a period of one year.

CLRB closed Thursday's trading at $3.80, up 8.57%.

DURECT Corp. (DRRX) has been asked to make a number of amendments to its ongoing phase III trial of POSIMIR, a locally-acting nonopioid analgesic, known as PERSIST.

Consequently, the company has decided to implement the recommendations as a result of which, will add to the time and cost to complete the trial.

DRRX closed Thursday's trading at $1.33, down 0.75%. In after-hours, the stock fell 9.77% to $1.20.

Galapagos NV (GLPG) and MorphoSys AG have initiated a phase I study of MOR106 in healthy volunteers. MOR106, jointly discovered by Galapagos and MorphoSys, is a human IgG1 monoclonal antibody for treatment of inflammatory diseases.

The primary objective of the phase 1 study is to evaluate the safety and tolerability of single doses of MOR106. The study enables the initiation of a subsequent multiple ascending dose (MAD) study in patients, depending on the outcome of the single ascending dose study in healthy volunteers.

Topline results of the complete study, including the potential subsequent MAD part in patients, are expected in the second half of 2017.

GLPG closed Thursday's trading at $43.95, down 1.79%.

Ionis Pharmaceuticals Inc.'s (IONS) phase III study of IONIS-TTRRx in patients with transthyretin familial amyloid polyneuropathy, dubbed NEURO-TTR, is ongoing as planned, and is on track to complete in the first half of 2017.

A phase III study to evaluate IONIS-TTRRx in patients with TTR amyloid cardiomyopathy, known as CARDIO-TTR, planned by GSK has been placed on clinical hold by the FDA while GSK provides answers to questions about the protocol stemming from Ionis' ongoing NEURO-TTR study.

IONS closed Thursday's trading at $41.40, down 11.03%.

An FDA panel has voted 17 to 0 to recommend accelerated approval of Intercept Pharmaceuticals Inc.'s (ICPT) Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis.

Primary biliary cirrhosis, or PBC, is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40.

The FDA's final decision on Ocaliva is set for May 29, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.

ICPT was up 11.08% in after hours at $181.98.