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08.06.2016 06:30:15

ALDX Expects Data In Q3, CATB Tumbles On Study Data, Teva Gets FDA Panel Nod

(RTTNews) - Aldeyra Therapeutics Inc. (ALDX) has completed enrollment and dosing of patients in its phase II clinical trial of topical NS2 in patients with Sjögren-Larsson Syndrome.

Sjögren-Larsson Syndrome is a rare inborn error of aldehyde metabolism, which results in a severe skin disease called ichthyosis.

The company expects to provide data from the trial in the third quarter of this year.

ALDX closed Tuesday's trading at $5.93, up 5.89%.

Shares of Biogen (BIIB) dropped 12% on Tuesday after the company reported that its phase II study of Opicinumab in people with relapsing forms of multiple sclerosis missed the primary endpoint.

In the study, dubbed SYNERGY, Opicinumab missed the primary endpoint, a multicomponent measure evaluating improvement of physical function, cognitive function, and disability. The drug candidate also did not meet the secondary efficacy endpoint of slowing of disability progression.

BIIB closed Tuesday's trading at $252.86, down 12.76%.

Shares of Catabasis Pharmaceuticals Inc. (CATB) were down over 31% in extended trading on Tuesday, following failure of its phase IIa clinical trial of CAT-2054 for the treatment of hypercholesterolemia.

According to the company, four weeks of treatment with CAT-2054 in patients with hypercholesterolemia on a high-intensity statin did not result in reduction in LDL-cholesterol (LDL-C) from baseline.

CATB closed Tuesday's trading at $6.85, down 3.79%. In after hours, the stock was down 31.39% to $4.70.

CoLucid Pharmaceuticals Inc. (CLCD) announced that the last patient has been randomized in SAMURAI study, its first phase III trial of oral Lasmiditan for the acute treatment of migraine in adults.

The company continues to expect top-line data from the SAMURAI study in the third quarter of 2016.

CLCD closed Tuesday's trading at $7.16, down 7.49%.

Cytori Therapeutics Inc. (CYTX) has completed enrollment in its phase III pivotal study investigating the efficacy and safety of Cytori Cell Therapy injected subcutaneously into the fingers of patients with impaired hand function from scleroderma.

In the study, dubbed STAR, a total of 88 patients were enrolled ahead of schedule, and all procedures were completed successfully without complications.

The company expects data from the STAR study to be available mid-2017.

CYTX closed Tuesday's trading at $2.32, down 2.93%.

Galmed Pharmaceuticals Ltd. (GLMD) has expanded the clinical operations of its ongoing phase IIb clinical study of Aramchol in subjects with nonalcoholic steatohepatitis, who are overweight or obese, and who are pre-diabetic or type-II-diabetic.

A pharmacokinetic study, consisting of Part A and Part B, in Chinese subjects who are domiciled in the United States has also been initiated by the company. The results of Part A of the pharmacokinetic study are expected to be available in August 2016.

GLMD closed Tuesday's trading at $4.14, up 2.73%.

An FDA panel has voted 14 to 3 to recommend approval of Teva Pharmaceutical Industries Ltd.'s (TEVA) VANTRELA ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

VANTRELA ER is an extended-release formulation of hydrocodone bitartrate with Teva's proprietary abuse deterrence technology. The NDA for VANTRELA ER has been under FDA review since February 2015.

TEVA closed Tuesday's trading at $54.06, down 1.15%.

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Aktien in diesem Artikel

Aldeyra Therapeutics 4,62 -0,73% Aldeyra Therapeutics
Biogen Inc 152,30 0,79% Biogen Inc
Galmed Pharmaceuticals Ltd. 2,86 0,00% Galmed Pharmaceuticals Ltd.
Teva Pharmaceutical Industries Ltd. (spons. ADRs) 15,90 0,00% Teva Pharmaceutical Industries Ltd. (spons. ADRs)