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12.09.2016 08:46:24

Sweet Tidings For LXRX, CYAD To Report Data In Q4, D-Day For FOMX Today

(RTTNews) - Auris Medical Holding AG's (EARS) phase III clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, also known as sudden deafness, has now enrolled more than 125 patients out of the target of 255 patients.

The trial dubbed HEALOS, which is being conducted in Europe and Asia, has now reached the midpoint for enrollment. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28.

The company expects to report top-line results from the trial in the second half of next year, in line with previous guidance.

EARS closed Friday's trading 15.19% higher at $1.82.

Celyad (CYAD) has successfully completed 21-day safety follow-up of the last patient in its phase I clinical trial of NKR-2 T-cell therapy in Acute Myeloid Leukemia and Multiple Myeloma patients.

No safety issues or dose limiting toxicity were observed in the trial. Results of the trial are expected to be available in late Q4 2016.

CYAD closed Friday's trading at $23.55, up 8.41%.

Foamix Pharmaceuticals Ltd. (FOMX) is all set to report phase II results of FMX103, which is being tested for the treatment of papulopustular rosacea, today.

Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone.

FOMX closed Friday's trading at $8.79, up 0.46%.

Shares of Lexicon Pharmaceuticals Inc. (LXRX) were up over 16% on Friday, following positive top-line results in pivotal phase III study for Sotagliflozin in patients with Type 1 diabetes.

According to the study results, patients treated with 200mg once daily Sotagliflozin had a mean *A1C reduction from baseline of 0.43% while patients treated with 400mg once daily Sotagliflozin dose had a reduction of 0.49% compared to a reduction of 0.08% on placebo after 24 weeks of treatment, meeting the study's primary endpoint. *A1C refers to the average blood glucose level over a span of a 2 or 3 months.

A similar pivotal phase III trial predominantly in Europe, dubbed inTandem2, is also underway - with top-line results expected by the end of the year.

The third phase III clinical trial, known as inTandem3, is evaluating Sotagliflozin 400mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization.

LXRX closed Friday's trading at $17.85, up 16.59%.

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