GALT Vaults, BIOD, CCXI, ESPR Await Q3 Catalysts, Watch Out For OSIR

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) expects to submit its New Drug Application for Zalviso, designed to improve the management of moderate-to-severe acute pain in patients in the hospital setting, by the end of the third quarter.

ACRX closed Monday's trading at $10.82, down 2.70%. In after-hours, the stock lost another 1.48% to $10.66.

Shares of Avanir Pharmaceuticals Inc. (AVNR) rose more than 9 percent to $4.93 in extended trading on Monday after the company announced that it has entered into an exclusive, multi-year agreement with Merck (MRK) to co-promote Merck's type 2 diabetes therapies JANUVIA (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States.

Under the terms of this agreement, Avanir will be compensated via a fixed fee plus an incentive-based payment. Merck will continue to remain responsible for the promotion of the sitagliptin family of products in all other settings and will remain responsible for all other aspects of research, manufacturing and marketing.

Biodel Inc. (BIOD) expects top-line data from a phase II clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy, this quarter (Q3, 2013).

The clinical trial is designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

BIOD lost 8.81% in Monday's trading to close at $4.45. In after-hours, the stock was up 0.90% to $4.49.

ChemoCentryx Inc. (CCXI) expects interim 12-week results from its phase II trial of CCX140 in diabetic nephropathy in the third quarter of this year.

Another event to watch out for is the data readout of Vercirnon, the company's most advanced drug candidate, being developed in partnership with GlaxoSmithKline, which is expected in early fourth quarter of 2013. Vercirnon is under phase III trial in Crohn's disease, dubbed SHIELD-1.

CCXI closed Monday's trading at $12.66, down 1.09%.

Esperion Therapeutics Inc. (ESPR) expects top-line results from a phase 2a study of ETC-1002-007 in patients with hypercholesterolemia taking a 10 mg dose of atorvastatin to be reported in the first half of September 2013.

A phase 2b clinical study of ETC-1002-008 in patients with hypercholesterolemia and either a history of statin intolerance or a history of statin tolerance is scheduled to be initiated in October of this year.

ESPR closed Monday's trading 3.24% higher at $17.23.

Galectin Therapeutics (GALT) touched a new 52-week high of $7.95 on Monday before closing at $6.78, up more than 21 percent from the previous day's close, following its drug candidate GR-MD-02 securing Fast Track status.

The FDA has granted GR-MD-O2, which is under phase I testing, Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis.

The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

GeoVax Labs Inc. (GOVX.OB) expects preliminary data of its vaccine in HIV-positive patients in a study dubbed phase 1 "treatment interruption" clinical trial to be released in the second half of 2013, and final results and evaluation of trends in the first half of 2014.

The company expects a phase I trial of its second-generation HIV vaccine, known as HVTN094, to be completed in 2013. A phase II trial of the vaccine is expected to be initiated in 2014, following successful completion of HVTN094.

GOVX.OB closed Monday's trading at $0.48, up 2.13%.

Organovo Holdings Inc. (ONVO), a developer of functional, three-dimensional human tissues for medical research and therapeutic applications, expects to launch its first commercial product in 2014.

ONVO closed Monday's trading at $5.60, up 1.82%.

Osiris Therapeutics Inc. (OSIR) will be hosting a conference call on August 13, 2013 at 9:00 a.m. ET to discuss the results of interim analysis of its multicenter, randomized, controlled trial evaluating the efficacy and safety of its approved biosurgery product Grafix for the treatment of chronic diabetic foot ulcers.

Osiris currently markets Grafix for burns and chronic wounds.

OSIR closed Monday's trading at $10.66, up 1.91%.

Response Genetics Inc. (RGDX) on Monday announced that it has signed a contract with MultiPlan Inc., the industry's most comprehensive provider of healthcare cost management solutions. The contract will allow MultiPlan's clients to have access to all of Response Genetics' molecular diagnostic testing.

Response Genetics increased its revenue by more than 38% and narrowed its loss over two-fold in the second quarter ended June 30, 2013, the results of which were announced last week.

RGDX closed Monday's trading at $2.05, up 14.53%.

Tekmira Pharmaceuticals Corp. (TKMR) has initiated a phase I/II clinical trial with TKM-PLK1, which will enroll patients with advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC), and expect results from this trial by mid-2014.

The company will also be initiating another phase I/II clinical trial with TKM-PLK1, enrolling patients with hepatocellular carcinoma in the first half of 2014.

TKMR gained 1.08% in Monday's trading to close at $5.63.

Shares of Vical Inc. (VICL) lost 57 percent of their value on Monday as a phase III trial of the company's investigational treatment for metastatic melanoma - Allovectin, did not meet either the primary or secondary efficacy endpoints. The company has decided to terminate the Allovectin program in the wake of study failure.