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Company Description (as filed with the SEC)
We are a clinical-stage biopharmaceutical company focused on the development of novel products for the treatment of inner ear disorders. Our most advanced product candidate, AM-101, is in Phase 3 clinical development for acute inner ear tinnitus under a special protocol assessment, or SPA, from the FDA. In two recently completed Phase 2 clinical trials, AM-101 demonstrated a favorable safety profile and statistically significant improvement in tinnitus loudness and other patient reported outcomes. We expect to have top-line Phase 3 clinical data for AM-101 in early 2016. We are also developing AM-111 for acute inner ear hearing loss. The FDA held a pre-IND meeting with us in September 2014 and provided formal feedback and guidance on our pre-clinical and CMC development and specifically on HEALOS. In response to this feedback, we are in the process of finalizing the design of HEALOS. In addition, we obtained an open IND from the FDA for REACH. ... More ...
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|Annual EPS Est:||$-0.66|
|Quarterly EPS Est:||-0.28|