ISIS Does It Again, LXRX Shines On TELESTAR Data, ACRX Awaits EC Approval

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) expects European Commission's decision on the approval of Zalviso, proposed for the management of acute moderate-to-severe post-operative pain in adult patients in a hospital setting, in late September or early October.

The Committee for Medicinal Products for Human Use - the European equivalent to the FDA panel - adopted a positive opinion for Zalviso on July 23, 2015.

In the U.S., Zalviso is not approved by the FDA, and was issued a complete response letter last July.

ACRX closed Monday's trading at $4.05, down 1.70%. In after hours, the stock was up 1.48% to $4.11.

Shares of Chimerix Inc. (CMRX) touched a new high on Monday, following completion of enrollment of the targeted 200 patients in a phase III trial evaluating Brincidofovir for the treatment of adenovirus infection in immunocompromised patients.

The study is known as AdVise, and its primary endpoint is overall survival. Earlier this year, preliminary results from the initial 85 patients enrolled in the AdVise trial and treated with Brincidofovir showed a mortality rate of less than 40% for bone marrow transplant recipients with disseminated adenovirus disease and for the patient population overall.

CMRX touched a new high of $55.74 on Monday before closing the day's trading at $55.72, up 3.68%.

Cidara Therapeutics Inc. (CDTX) has advanced CD101 IV, its lead drug candidate to treat fungal and other infections, to a phase I trial in healthy subjects ahead of schedule.

CD101 IV is a novel, long-acting antifungal that could ultimately provide physicians with a new treatment option for their patients fighting serious, life-threatening fungal infections, according to the company.

Cidara went public in April of this year, offering its shares at a price of $16.00 each. The stock closed Monday's trading at $14.52, up 3.86%.

DURECT Corp. (DRRX), which received a Complete Response Letter from the FDA for its investigational post-operative pain relief depot Posidur last year, plans to begin a new POSIDUR phase III clinical trial in the fall of 2015.

The trial will enroll approximately 300 patients undergoing laparoscopic cholecystectomy (gallbladder removal) surgery, and the company expects that it will take approximately one year to complete enrollment.

The new phase III Posidur trial is designed to generate data necessary to support an NDA resubmission, noted the company.

DRRX closed Monday's trading 2.55% higher at $2.41.

Isis Pharmaceuticals Inc. (ISIS) has reported positive results from a phase III study of its approved product Kynamro in patients with severe heterozygous familial hypercholesterolemia, or severe HeFH.

The study, dubbed FOCUS FH, met its primary efficacy endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once weekly injections of 200 mg of Kynamro compared to placebo.

Kynamro is already approved by the FDA as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). Isis licensed Kynamroi to Genzyme in 2008.

ISIS closed Monday's trading at $53.96, down 1.77%.

Shares of Lexicon Pharmaceuticals Inc. (LXRX) soared more than 61% on Monday, following positive results from the company's phase III trial of its oral drug candidate Telotristat etiprate in cancer patients with Carcinoid syndrome.

Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors, and is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death.

The study, dubbed TELESTAR, demonstrated that patients who added Telotristat etiprate to Somatostatin analog depot injection, the standard of care, at 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period.

The 12-week study period is being followed by a 36-week open-label extension where all patients receive Telotristat etiprate 500 mg three times daily.

Lexicon plans to announce complete results from the phase 3 TELESTAR study at an upcoming scientific conference.

LXRX closed Monday's trading at $13.60, up 61.14%.

Nivalis Therapeutics Inc. (NVLS), which went public recently, expects its phase 1b study for N91115 in people who have cystic fibrosis and have two copies of the F508del mutation to be completed in the third quarter of 2015, with results presented at an appropriate scientific meeting later this year.

The company plans to initiate a phase II study of N91115 in people with CF who have two copies of the F508del mutation in the fourth quarter of 2015.

NVLS went public on June 17, 2015, pricing its shares at $14 each. The stock closed Monday's trading at $16.72, down 1.47%.

Protalix BioTherapeutics Inc.'s (PLX) phase I trial of PRX-106 in healthy volunteers has demonstrated a favorable safety and tolerability profile and biological activity in the gut.

The trial enrolled 14 subjects that were randomized to one of three dosing cohorts receiving PRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects received once daily oral administrations for 5 consecutive days, said the company.

PLX closed Monday's trading at $1.72, up 4.88%.

Zoetis Inc.'s (ZTS) Canine Atopic Dermatitis Immunotherapeutic to help reduce clinical signs associated with atopic dermatitis in dogs has received a conditional license from the U.S. Department of Agriculture.

Canine Atopic Dermatitis Immunotherapeutic will be available in a ready-to-use, sterile liquid administered as a once-monthly subcutaneous injection and will help provide sustained relief from the itching associated with atopic dermatitis in dogs of any age, the company said.

Zoetis said it will make the Canine Atopic Dermatitis Immunotherapeutic available primarily to veterinary dermatology specialists early in the fourth quarter of 2015 to gain more experience with this first antibody therapy in canine dermatology and acquire a deeper understanding of how veterinarians will use it in clinical practice. This will help the company prepare for full licensure.

ZTS closed Monday's trading at $48.48, down 1.02%.