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Auris Medical Holding Ltd. (NASDAQ: EARS) announced positive results from its clinical evaluation of BentrioTM for allergic rhinitis. The nasal spray showed a significant reduction in Total Nasal Symptom Score (TNSS) during a pollen challenge, with patients rating its efficacy higher than a comparator. The company has received favorable feedback from the FDA regarding its 510(k) submission process, indicating the study design is adequate. BentrioTM is expected to launch in selected European markets by June 2021, enhancing Auris Medical's product portfolio in allergy treatment.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced significant progress in the AM-301 nasal spray program, designed for protection against airborne viruses and allergens. The clinical evaluation demonstrated that AM-301 met its primary endpoint for allergic rhinitis, providing extended protection for over three hours. Preliminary data also suggest efficacy against SARS-CoV-2 post-infection. The product, branded as Bentrio™, is expected to launch in selected European countries by the end of Q2 2021, with plans for a subsequent U.S. FDA 510(k) submission for regulatory clearance.
Auris Medical Holding Ltd. (NASDAQ: EARS) is set to provide a business update on its AM-301 program, which focuses on protection against airborne viruses and allergens, on April 13, 2021. The event will include a conference call and webcast starting at 8:00 am Eastern Time. This follows the company’s ongoing work in developing intranasal therapeutics for various medical needs, with several programs in different developmental phases, including AM-125 for vertigo and AM-111 for acute inner ear hearing loss.
Auris Medical Holding Ltd. (NASDAQ: EARS) reported a positive update on its AM-301 and AM-125 clinical programs, alongside its financial results for 2020. The AM-301 nasal spray, aimed at protecting against airborne viruses, is expected to launch in selected markets by Q2 2021. Meanwhile, the AM-125 trial for acute vertigo is progressing, although enrollment faced delays due to COVID-19. The company has strengthened its balance sheet with CHF 16.6 million raised in equity, expecting cash needs of CHF 11.5 to 13 million for 2021 operations.
Auris Medical Holding Ltd. (NASDAQ: EARS) will provide a business update and report financial results for the second half and full year 2020 on March 31, 2021. Following the announcement, management will host a conference call at 8:00 am ET. The company is focused on therapeutics for unmet medical needs in neurotology and CNS disorders. Key developments include AM-125 for vertigo in Phase 2, AM-201 in post Phase 1b, and two Phase 3 programs: Sonsuvi® for acute inner ear hearing loss and Keyzilen® for tinnitus.
Auris Medical Holding Ltd. (NASDAQ: EARS) has initiated a clinical investigation of AM-301, a drug-free nasal spray, designed to treat allergic rhinitis triggered by airborne allergens. This randomized study will enroll 36 patients to test AM-301 against a comparator in a controlled environment, measuring the Total Nasal Symptom Score as the primary endpoint. Results are expected in Q2 2021. The company also aims to test AM-301 against airborne viruses, including SARS-CoV-2. Auris Medical plans to introduce AM-301 in select markets in late Q2 2021.
Auris Medical Holding Ltd. (NASDAQ: EARS) reported a net cash inflow of $13.4 million through a registered direct offering and warrant exercises. The funds will support the AM-301 program, which is advancing towards clinical trials for a drug-free nasal spray against airborne pathogens and allergens. The clinical study is set to begin in early 2021, with expectations for CE marking in the second quarter of 2021. The company's ongoing strategy review may lead to potential transactions aimed at enhancing shareholder value.
Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage therapeutics developer, announced that Chairman and CEO Thomas Meyer will present at the 13th Annual LD Micro Main Event on December 15, 2020, at 10:40 a.m. EST. The event will be available via live webcast.
The company focuses on unmet medical needs in neurotology, rhinology, and CNS disorders, with products like AM-125 for vertigo and AM-111 for acute inner ear hearing loss under development. Auris Medical, founded in 2003, is headquartered in Hamilton, Bermuda, with operations in Basel, Switzerland.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced a registered direct offering of 2,000,000 common shares at $4.00 per share, totaling approximately $8,000,000 in gross proceeds. The net proceeds will be utilized for working capital and general corporate purposes. Closing is expected on or about December 4, 2020. A.G.P./Alliance Global Partners is the sole placement agent for this offering, conducted under an effective shelf registration statement with the SEC. Auris focuses on developing therapeutics for neurotology, rhinology, and CNS disorders.
Auris Medical Holding Ltd. (NASDAQ: EARS) announced promising efficacy results for its drug-free nasal spray AM-301, designed to mitigate the risk of SARS-CoV-2 infection. In a recent study, AM-301 demonstrated up to 99.4% reduction in viral titer in human epithelial cell cultures, significantly outperforming saline controls. Conducted over four days, the treatment effectively protected nasal cells against viral infection. CEO Thomas Meyer expressed excitement over these results, emphasizing their potential in advancing AM-301 towards regulatory application in 2021.
