KYTH Gets A Facelift, PSTI To Resume Study, One Up, Two To Go For NBY

(RTTNews) - Shares of KYTHERA Biopharmaceuticals Inc. (KYTH) rose 40 percent to $40 in extended trading on Monday after the company announced that two phase III trials of its drug candidate ATX-101 for the reduction of unwanted fat under the chin demonstrated statistically significant results for primary and secondary endpoints.

The two phase III trials, dubbed REFINE-1 and REFINE-2, enrolled more than 1,000 subjects with moderate to severe submental fat in 70 centers in the U.S. and Canada.

Repros Therapeutics Inc.'s (RPRX) investigational drug for male reproductive health - Androxal, has met both co-primary endpoints in its second pivotal efficacy study. The compound was also generally well tolerated in a 6 month safety study.

The company noted that its NDA filing for Androxal remains on track for mid-2014. If all goes well as planned, the drug is expected to be launched during 2015.

RPRX closed Monday's trading 6.18% down at $21.26.

Tonix Pharmaceuticals Holding Corp. (TNXP) has commenced its phase 2b trial of its lead therapeutic candidate, TNX-102 SL 2.8 mg tablets, dubbed BESTFIT, in patients with fibromyalgia.

The top-line results from the trial are expected in the second half of 2014.

TNX-102 SL is also being explored in other indications, including post-traumatic stress disorder.

TNXP shed 6.28% to close Monday's trading at $3.73.

Quidel Corp. (QDEL) has received FDA clearances for molecular diagnostic tests for use on Life Technologies Corp's (LIFE) flagship instrument QuantStudio Dx.

The newly authorized Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay add to the infectious disease menu available on the QuantStudio Dx instrument with assays for the diagnosis of some of the more common respiratory tract infections that often share similar influenza-like symptoms.

QDEL closed Monday's trading 0.19% down at $26.95.

NovaBay Pharmaceuticals Inc.'s (NBY) phase II study of its lead Aganocide compound Auriclosene, formerly known as NVC-422, to reduce urinary catheter blockage and encrustation, has demonstrated statistically significant and clinically meaningful benefits in patients with chronic indwelling urinary catheters.

Aganocides offer a broad spectrum of activity against bacteria, viruses and fungi by mimicking the body's natural defense infection.

An estimated 100,000 patients in the U.S. have indwelling catheters because of spinal cord injuries, multiple sclerosis, strokes, or other neurogenic bladder conditions. Patients who have a catheter inserted into the bladder for a long term are often prone to encrustation of catheters, arising from infection by urease-producing bacteria.

Auriclosene is also under phase II testing as potential treatments for skin infection impetigo and eye infection adenoviral conjunctivitis. The company expects data from the dermatology trial by the end of 2013 and ophthalmology trial in the first half of 2014.

NBY rose 24.64% to close Monday's trading at $1.72. In after-hours, the stock gained another 1.16% to $1.74.

NeoStem Inc. (NBS) has licensed three patent families covering its human regulatory T cell, or Treg, cells with therapeutic potential for autoimmune disorders from the University of California, San Francisco, or UCSF.

The company recently announced collaboration with UCSF and the laboratories of Drs. Jeffrey Bluestone and Qizhi Tang, to develop Tregs for the treatment of type 1 diabetes, steroid resistant asthma, and organ transplant rejection.

The clinical hold placed by FDA on Pluristem Therapeutics Inc.'s (PSTI) phase II Intermittent Claudication study of its patented PLX-PAD cells has been lifted. The company said it looks forward to resuming the trial.

PSTI closed Monday's trading 6.52% higher at $3.43.