CGNT Abuzz, Retrophin's DUET Hits Right Notes, Watch Out For RPRX

(RTTNews) - Arrowhead Pharmaceuticals Inc. (ARWR) has dosed the first patient in the multiple ascending dose portion of its ongoing phase 1/2 study of ARC-521 for the treatment of chronic hepatitis B virus infection.

The readouts from the study, including single dose safety data in healthy volunteers and single and multiple dose safety and antiviral activity data in HBV patients, will potentially start during the first quarter of 2017, the company said.

ARWR closed Wednesday's trading at $7.34, up 2.51%.

Shares of Cogentix Medical Inc. (CGNT) got a lift Wednesday, following a securities purchase agreement which the company entered into with Accelmed Growth Partners L.P.

As per the agreement terms, Accelmed would purchase $25 million of Cogentix Medical common stock from the company at $1.55 per share, a 29% premium over the closing price of the stock on September 6, 2016 and a premium of 36% over the average closing price over the last 30 days.

Cogentix noted that it will convert into common shares all the outstanding debt and accrued interest totaling $29.5 million owed to Lewis Pell, one of its Class I directors.

CGNT closed Wednesday's trading 50.83% higher at $1.81.

CytRx Corp. (CYTR) has reached its enrollment target of 132 patients for its global phase 2b clinical trial of Aldoxorubicin in patients with previously treated small cell lung cancer. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival, response rates and safety.

If all goes well as planned, the company intends to meet with the FDA to discuss the regulatory pathway for the submission of a New Drug Application for Aldoxorubicin based on the phase II results.

CYTR closed Wednesday's trading at $0.58, down 0.09%.

La Jolla Pharmaceutical Co. (LJPC) is all set to initiate a pivotal study of LJPC-401 in beta thalassemia patients suffering from iron overload in mid-2017, now that it has reached an agreement with the European Medicines Agency on the design of the study.

LJPC-401 is La Jolla's novel formulation of synthetic hepcidin.

In related news, the company reported positive results from its phase 1 study of LJPC-401 in patients at risk of iron overload. According to the study results, a dose-dependent, statistically significant reduction in serum iron was observed in the study. LJPC-401 was also well tolerated, and there were no dose-limiting toxicities.

LJPC closed Wednesday's trading at $16.02, down 2.38%.

Merck's (MRK) supplemental Biologics License Application for KEYTRUDA for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors express PD-L1 has been assigned priority review, with a decision date set for Dec. 24, 2016.

KEYTRUDA is already approved for the treatment of metastatic melanoma and metastatic non-small cell lung cancer, and for treating patients with recurrent or metastatic head and neck squamous cell carcinoma. The drug generated global sales of $566 million in 2015 - the first full year on market, and $563 million in the six months ended June 30, 2016.

MRK closed Wednesday's trading at $62.87, down 0.59%.

The phase II results of Repros Therapeutics Inc.'s (RPRX) oral Proellex for the treatment of premenopausal women with confirmed symptomatic endometriosis, announced Wednesday, are encouraging.

According to the company, subjects with moderate to severe endometriosis experienced relief of menstrual pain and a reduction in the use of pain medication with the use of Proellex.

More specifically, subjects treated with Proellex had a statistically significant greater reduction in menstrual pain compared to the 37.5% change from baseline achieved with placebo. Additionally, the total pain medication use decreased 56% and non-prescription pain medication use decreased 74% in subjects treated with Proellex.

RPRX closed Wednesday's trading at $1.90, down 2.56%.

Shares of Retrophin Inc. (RTRX) rose as much as 44% on Wednesday, following positive top-line results from its phase II study of Sparsentan for the treatment of focal segmental glomerulosclerosis.

Focal segmental glomerulosclerosis, or FSGS, is a rare kidney disease that scars the kidneys, causing them to lose functionality. FSGS is a common cause of proteinuria, a condition which refers to abnormal amount of protein in the urine.

In the phase II study, dubbed DUET, the mean reduction of proteinuria from baseline after eight weeks of treatment for all patients treated with 200, 400, and 800 mg/day of Sparsentan was 44.8 percent, compared to a mean reduction of proteinuria for all patients receiving 300 mg/day of Irbesartan of 18.5 percent. Irbesartan is part of a class of drugs used to manage focal segmental glomerulosclerosis in the absence of an approved pharmacologic treatment.

However, the comparison of individual Sparsentan dose cohorts to Irbesartan did not reach statistical significance. But, there were clear signals of relative improvement, said the company.

RTRX closed Wednesday's trading at $20.81, up 27.51%.