AKBA Hits New 52-week High, PMD Launches Hair Test, Mateon Runs Out Of FOCUS

(RTTNews) - Today's Daily Dose brings you news about Akebia's phase II trial of kidney disease drug; Ascendis' progress in hypoparathyroidism trial; Avinger's receipt of CE Mark; disappointing results of Mateon's FOCUS study and Psychemedics' launch of hair test.

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Akebia Therapeutics Inc. (AKBA) has reported positive results from its phase II study of Vadadustat in Japanese patients with anemia associated with non-dialysis-dependent chronic kidney disease.

The results confirm findings from previous studies of Vadadustat.

By the end of 2017, the Company, in collaboration with Mitsubishi Tanabe Pharma Corporation, expects to announce top-line data from a phase II study of Vadadustat in dialysis patients with chronic kidney disease and initiate a Phase 3 development program in non-dialysis patients in Japan.

AKBA touched a new 52-week high of $17.99 on Tuesday, before closing the day's trading at $17.53, down 2.07%.

Ascendis Pharma A/S (ASND) has dosed subjects in a phase I trial of TransCon PTH, a long-acting prodrug of parathyroid hormone in development for the treatment of hypoparathyroidism.

The phase I trial is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of TransCon PTH in healthy adults.

Jonathan Leff, Ascendis Pharma's Chief Medical Officer, said, "Based on extensive clinical experience with PTH replacement therapies, we believe that if this phase 1 trial is successful we can advance TransCon PTH directly into a phase 3 pivotal trial with the ultimate goal of helping patients who suffer from this debilitating disease".

ASND closed Tuesday's trading at $37.10, up 2.68%.

Avinger Inc. (AVGR) has received CE marketing approval for in-stent restenosis treatment indication with the Pantheris Lumivascular atherectomy system.

In-stent restenosis occurs when a previously blocked artery treated with a stent becomes narrowed again, blocking blood flow. The current therapies for in-stent restenosis such as balloon angioplasty suffer from high rates of recurrent renarrowing within stents, according to the Company.

AVGR closed Tuesday's trading at $0.21, down 9.13%.

Catalent Inc. (CTLT) has priced its public offering of 6.39 million shares of its common stock at a price of $39.10 each to fund part of its previously announced pending acquisition of Cook Pharmica LLC.

The offering is expected to close on or about September 29, 2017. The Company has granted the underwriters an option for 30 days to purchase up to an additional 959,250 shares of its common stock.

The net proceeds from the offering are estimated to be about $242.2 million.

CTLT closed Tuesday's trading at $39.21, down 3.87%.

Forward Pharma A/S (FWP) on Tuesday reported financial results for the six-month period ended June 30, 2017.

Net income for the six-month period ended June 30, 2017 was $941.2 million or $1.91 per share compared to a net loss of $32.0 million or $0.07 per share in the year-ago same period.

During the six-month period ended June 30, 2017, the Company recognized as revenue the $1.25 billion nonrecurring non-refundable fee that was received during February 2017 in connection with the Settlement and License Agreement entered into with two wholly owned subsidiaries of Biogen Inc. (BIIB).

FWP closed Tuesday's trading at $5.62, up 0.72%.

Mateon Therapeutics Inc. (MATN) has decided to terminate its phase 2/3 study evaluating CA4P in combination with Avastin and physician's choice chemotherapy in patients with platinum-resistant ovarian cancer, dubbed FOCUS, due to lack of clear efficacy signal.

Due to the lack of a meaningful improvement in progression-free survival, combined with the unfavorable partial response data, continuation of the study is not appropriate, the Company noted.

MATN.OB closed Tuesday's trading at $0.425, down 6.68%.

Psychemedics Corp. (PMD) has launched its FDA-cleared Benzodiazepines hair test, which detects numerous Benzodiazepines, including Xanax, Valium, and Ativan.

The abuse of prescription Benzodiazepines has grown at an alarming rate in the United States, contributing to thousands of emergency room visits and overdose deaths each year, according to the Company.

Unlike urinalysis or oral fluid testing which typically detects drug use for only the previous one to three days, Psychemedics hair analysis can detect use over the previous few months, the Company added.

PMD closed Tuesday's trading at $18.16, up 4.19%.