NEW YORK, NY / ACCESSWIRE / March 9, 2018 / Shares of Atossa ended in the green on Thursday but fell deep into the red in after-hours trading when it announced its financial report for 2017. Shares of Jaguar Health were soaring after announcing that the FDA has indicated that its Reasonable Expectation of Effectiveness (RxE) Technical Section is complete towards conditional approval of the company's lead veterinary drug product candidate.
RDI Initiates Coverage on:
Atossa Genetics Inc.
Jaguar Health, Inc.
Atossa Genetics Inc. shares were flying high in Thursday trading, closing the day up 18.94%, but then saw all of those gains wiped out in after-hours trading when the company reported 2017 financial results and provided a Company update. For the year ended December 31st, 2017, Atossa reported total operating expenses of $7,649,171. This was a decrease from the year before. For last year and 2016 the company had no source of sustainable revenue and no associated cost of revenue. The company's President and CEO Dr. Steve Quay, stated, "In the later part of 2017, we completed a Phase 1 Study of our proprietary oral and topical Endoxifen formulations, and we were pleased to report that all study objectives were met. We are now looking forward to opening enrollment in two Phase 2 studies. One will use our oral Endoxifen to treat breast cancer patients who are not responding to tamoxifen. Tamoxifen is the current FDA-approved standard of care for the approximately one million breast cancer survivors to prevent a recurrence and new cancer. The second study will use our topical Endoxifen to determine if it can reduce a condition called mammographic breast density, or MBD. Mammographic Breast Density is an independent risk factor for developing breast cancer. "
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Jaguar Health, Inc. shares closed up 131% on Thursday with about 180 million shares traded. The stock was one of the biggest gainers on the NASDAQ after the commercial stage natural-products pharmaceuticals company announced some positive news regarding the FDA. The U.S. Food & Drug Administration's Center for Veterinary Medicine (CVM) has indicated that the company's Reasonable Expectation of Effectiveness (RxE) Technical Section is complete towards conditional approval of Canalevia™ for treatment of chemotherapy-induced diarrhea (CID) in dogs. Canalevia is the company's lead veterinary drug product candidate. The indication was based on CVM's review of the results of Jaguar's completed pilot study (CANA-001) of Canalevia™. Vice president and clinical veterinarian, Dr. Michael Guy, DVM, MS, PhD, commented, "Jaguar has now completed two of the four required technical sections of the Company's application for conditional approval of Canalevia™ for CID in dogs. With receipt of conditional approval for this indication, we would expect to conduct the commercial launch of Canalevia™ for CID in dogs in mid-2019."
Access RDI's Jaguar Health, Inc. Research Report at:
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