Auris Medical AG
139 articles with Auris Medical AG
Closes acquisition of Orphan Drug Designation for betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS)
Auris Medical Announces Acquisition of Orphan Drug Designation and Secures Rights to In-License Additional Patents Related to Betahistine
Acquires Orphan Drug Designation for betahistine for the treatment of obesity associated with Prader-Willi syndrome (PWS)
Auris Medical Announces Results of Pre-IND Meeting With FDA For AM-201 Program in Olanzapine-Induced Weight Gain
Auris Medical Holding AG today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the Company's questions and provided guidance on its AM-201 program with intranasal betahistine for the prevention of olanzapine-induced weight gain.
Positive outcomes from second Phase 1 trial with intranasal betahistine
Auris Medical to Report Third Quarter 2018 Financial Results and Provide Business Update on Thursday, November 15, 2018
Auris Medical Holding AG today announced that it will provide a business update and report its financial results for the third quarter of 2018 on Thursday, November 15, 2018.
Auris Medical Announces Positive Results From Second Phase 1 Clinical Trial With Intranasal Betahistine
Bioavailability significantly higher than with oral administration
Auris Medical Receives FDA Guidance at Type C Meeting for AM-111 in the Treatment of Sudden Sensorineural Hearing Loss
Auris Medical Holding AG announced today feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for sudden sensorineural hearing loss.
Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today announced financial results for the second quarter ended June 30, 2018 and provided a business update.
Shares of Switzerland-based Auris Medical Holding AG shot up nearly 10 percent Monday after the company announced it received clearance to begin a new Phase III trial for AM-111, the company’s investigational treatment for acute inner ear hearing loss.
Auris Health Unveils the FDA-Cleared Monarch Platform, Ushering in a New Era of Medical Intervention
Company’s First Application of Its Innovative Flexible Robotics Platform Is Bronchoscopy
Auris Medical has gone down swinging again in attempting to develop a treatment for tinnitus after it announced its Phase III trial failed to meet endpoints.
Auris Medical Reports New Data Highlighting Superior Bioavailability of AM-125 Compared to Oral Betahistine
The results show markedly higher blood plasma concentrations when betahistine administered intranasally rather than orally.
The Company also agreed to issue warrants to purchase up to an aggregate of 7,499,999 common shares to the investors in a concurrent private placement.
Further analyses on the basis of the full data set provide additional confirmation of and support for AM-111's otoprotective effects in the profound acute hearing loss subpopulation.
Following the announcement, Auris Medical's management team will host a live conference call and webcast at 8:00 AM ET.
AM-111 failed to meet its primary endpoint, although the company is putting a positive spin on it by noting it was effective in a subpopulation.
Cash and cash equivalents at September 30, 2017, totaled CHF 20.2 million.
Auris Medical to Report Third Quarter 2017 Financial Results and Provide Business Update on Tuesday, November 28, 2017
Following the announcement, Auris Medical's management team will host a live conference call and webcast at 8:00 am Eastern Time.