NEW YORK, NY / ACCESSWIRE / October 16, 2018 / Biotech stocks Auris Medical Holding and Agile Therapeutics were both seeing big gains on Monday. Traders are waiting for an update from Auris Medical on Wednesday while Agile recently concluded its formal dispute resolution with the FDA over the complete response letter issued for the new drug application of Twirla.
RDI Initiates Coverage on:
Auris Medical Holding AG
Agile Therapeutics, Inc.
Auris Medical Holding AG shares were skyrocketing on Monday with gains of 40.82% and an additional 23.19% in after-hours trading. The stock traded about 75 million shares compared to an average trading volume of around 3.3 million shares. Wall Street seemed to be already gearing up for an update that the clinical stage company would be providing on Wednesday. The update will be on the company's intranasal betahistine program, including key results from the second Phase 1 trial. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is now in Phase 1. The company also has two Phase 3 programs under development: AM-111 for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus.
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Agile Therapeutics, Inc. shares were up 28.09% on tremendous trading volume compared to usual on Monday. Shares also continued climbing higher in after-hours trading for another 16.05% gain. It was announced recently that the company has concluded the formal dispute resolution with the U.S. Food and Drug Administration over the complete response letter that was issued for the new drug application of Twirla®. Twirla®, also known as AG200-15, is an investigational once-weekly prescription contraceptive patch. “We appreciate the constructive discussions we’ve had with the FDA during this formal dispute resolution process. We are pleased that OND has provided a path forward, and we plan to meet with the Division to discuss the specifics of the proposed wear study as soon as possible. We look forward to resubmitting the NDA for Twirla after completion of our wear trial and welcome the opportunity to discuss the potential safety and efficacy of Twirla at an Advisory Committee Meeting,” said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics, Inc. He added, “After we agree on the parameters of the wear study, we anticipate providing a further business update, which will review our cash guidance and planned resubmission timeline.”
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