ACT Gets Its Act Right, HART Given Privileged Status, FDA Nod Fails To Lift KERX

(RTTNews) - Actavis plc's (ACT) New Drug Application for investigational antibiotic Ceftazidime-avibactam, for the treatment of patients with Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI), including those caused by multi-drug resistant Gram-negative bacterial pathogens, has been accepted by FDA for review, with a decision expected during Q1 2015.

The NDA was submitted under 505(b)(2) regulatory pathway.

ACT closed Friday's trading at $231.29, up 0.62%. In after-hours, the stock gained another 1.57% to $234.91.

Harvard Apparatus Regenerative Technology Inc. (HART) has been granted orphan drug designation by FDA for its HART-Trachea, an experimental product intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma.

A sixth human tracheal transplant was performed using the HART-Trachea product at Krasnodar Regional Hospital in Russia in June of this year on a 24-year-old male suffering from extensive tracheal damage following an automobile accident . As of August 15, 2014, four of the six patients treated with HART-Trachea are alive, and the two that did not survive died of unrelated causes (car accident, unrelated surgery), according to the company.

The orphan drug status entitles the company to seven years of marketing exclusivity if its HART-Trachea is approved by the FDA.

HART closed Friday's trading at $8, up 5.54%.

Keryx Biopharmaceuticals Inc.'s (KERX) kidney drug Ferric Citrate (formerly known as Zerenex) received FDA approval on Friday for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

Despite the good news, the company's stock closed the day's trading at $17.01, down more than 5 percent, all because of the unexpected warning on the drug label about iron overload. The label warns that iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Therefore, patients receiving iron intravenously may require a reduction in dose or discontinuation of the IV iron therapy when being treated with Ferric Citrate.

Soligenix Inc. (SNGX.OB) has acquired a novel orphan drug candidate, known as SGX301 (synthetic hypericin), which is being developed pursuant to discoveries made at New York University Medical Center together with the Yeda Research and Development Company, Ltd.

Soligenix noted that SGX301 is poised to enter pivotal phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma (CTCL). As part of the acquisition, the company acquired all rights for SGX301, including intellectual property, and preclinical and clinical data.

SNGX.OB closed Friday's trading at $2.07, up 2.99%.