FOLD Unfolds, No Pain, All Gain For NBIX, VSAR Picks Up Velocity, RVNC On Watch

(RTTNews) - Adamas Pharmaceuticals Inc. (ADMS) has received a $30 million milestone payment from Forest Laboratories Holdings Limited, a subsidiary of Actavis plc (ACT), based on the recent FDA approval of Namzaric, formerly known as MDX-8704.

In November 2012, Adamas entered into an agreement with Forest Laboratories for the development and commercialization of MDX-8704 in the United States. Namzaric was approved by the FDA on December 24, 2014 for the treatment of moderate to severe dementia related to Alzheimer's disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

ADMS closed Thursday's trading at $16.92, down 0.35%.

Amicus Therapeutics (FOLD) announced additional positive data from its first phase III study and phase III extension study of its drug candidate Migalastat in Fabry patients, which demonstrated statistically significant improvements in key cardiac parameter in patients previously naïve to therapy.

The company noted that the cardiac data from both of its phase III studies, in addition to the favourable results on disease substrate reduction and stabilization of kidney function that was previously reported, represent a very compelling data package as it prepares to seek global approval of Migalastat monotherapy.

FOLD touched a new high of $9.63 on Thursday before closing the day's trading 7.38% higher at $9.17.

Conatus Pharmaceuticals Inc. (CNAT) on Thursday announced top-line results from acute-on-chronic liver failure and organ impairment clinical trials of its drug candidate Emricasan which provided confirmatory support for the continued development of the compound.

The reported results were from a phase 2 trial in patients with acute-on-chronic liver failure (ACLF), phase 1 trial in patients with mild, moderate and severe hepatic impairment, and phase 1 trial in patients with severe renal impairment.

The company noted that it is pleased that top-line data from its ACLF and organ impairment trials showed that Emricasan was well tolerated while providing the important PK/PD (pharmacokinetic/pharmacodynamics) data needed to continue the advancement of its program in liver cirrhosis. However, investors drove the stock price down 36.11% in after-hours to $6.60.

CytRx Corp. (CYTR) has reported positive interim results from its ongoing phase II trial of Aldoxorubicin for the treatment of Kaposi's Sarcoma in HIV-infected patients.

Kaposi sarcoma, or KS, is a cancer that causes lesions to grow in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs.

The clinical results reported are from 9 patients, 6 of which carried the worst KS prognosis. Efficacy results revealed that all 9 patients exhibited a decrease in skin lesions and in the number of cancer cells expressing the KS virus DNA.

CYTR closed Thursday's trading 7.37% higher at $3.64.

GW Pharmaceuticals plc.'s (GWPH) first of three phase III trials for the investigational product Sativex in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy has failed to meet the primary endpoint.

The company has two additional pivotal phase III trials ongoing which, if positive, would still allow for the submission of New Drug Application for Sativex in the U.S. Data from the remaining Sativex phase III trials are expected later this year.

GWPH closed Thursday's trading at $80.11, up 12.74%.

Shares of Neurocrine Biosciences Inc. (NBIX) rose more than 25 per cent on Thursday following positive top-line results from a phase III study of drug candidate Elagolix in patients with endometriosis.

Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist, discovered by Neurocrine and was licensed to Abbott Labs in 2010. Elagolix came under the aegis of AbbVie, when in 2013 Abbot Labs spun-off part of its business into a new company called AbbVie.

The study, which is the first of two ongoing phase 3 clinical trials, demonstrated that after six months of treatment, both doses of Elagolix (150 mg once daily and 200 mg twice daily) met the study's co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea), associated with endometriosis, at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale.

The results from the second phase III trial of Elagolix in patients with moderate-to-severe endometriosis-related pain are expected in late 2015.

NBIX closed Thursday's trading 25.59% higher at $27.48.

Shares of Protalix BioTherapeutics Inc. (PLX) rose more than 12 per cent on Thursday after the company reported positive interim data from a phase I/II clinical trial of PRX-102 for the treatment of Fabry disease.

The company noted that its drug candidate PRX-102 demonstrated meaningful clinical benefits across all key disease parameters like major reduction in Gb3 in Renal Peritubular Capillaries, significant improvement in all pain parameters, stabilization of cardiac and kidney function with favourable trends and low level of antibody formation.

PLX closed Thursday's trading 12.50% higher at $2.34.

Pharming Group NV and Salix Pharmaceuticals Ltd. (SLXP) announced that the first patient was treated in their phase 2 clinical study of Ruconest for prophylaxis in patients with hereditary angioedema.

This phase II study of Ruconest is expected to be completed later in 2015.

Ruconest was approved by the FDA last July for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.

Ruconest is manufactured by Pharming Group NV in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize Ruconest in North America.

SLXP closed Thursday's trading at $118.93, down 1.06%.

Shares of Revance Therapeutics Inc. (RVNC) were up more than 11 per cent in extended trading on Thursday following publication of positive data from the company's phase 1/2 study of RT002 injectable botulinum toxin type A for the treatment of moderate to severe glabellar (frown) lines in the peer reviewed journal, Dermatologic Surgery.

The company had reported the positive results from RT002 phase 1/2 study last April. According to the study results, 94% of the 48 subjects enrolled in the study were rated with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment by the clinical investigator while 83% of subjects assessed themselves as achieving None or Mild wrinkles at maximum frown at the same time point.

A phase II study comparing injectable RT002, BOTOX Cosmetic and a placebo is underway. The results from the study, dubbed study BELMONT, are expected in late 2015.

The company's lead product candidate RT001 (Botulinum Toxin Type A) Topical Gel for the treatment of lateral canthal lines (crow's feet lines) in under phase III development, with results anticipated during the first quarter of 2015.

RVNC closed Thursday's trading 3.16% higher at $16.98. In after-hours, the stock was up another 11.90% at $19.00.

Versartis Inc. (VSAR) has initiated a phase III study of VRS-317 for semi-monthly dosing in children with growth hormone deficiency.

The study, dubbed VELOCITY, is expected to enroll up to 136 naïve to treatment, pre-pubertal children with growth hormone deficiency, with six month interim results anticipated in mid-2016 and final data in early 2017.

VSAR closed Thursday's trading at $22.38, up 2.08%.