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Outlook Therapeutics Provides Business Update and Reports Financial Results for Fiscal Year 2018
Dec. 18, 2018 09:50AM PST
Life Science Investing NewsOutlook Therapeutics (NASDAQ:OTLK) reported financial results and business highlights for its fiscal year ended September 30, 2018. As quoted in the press release: The Company’s wet AMD clinical program was reviewed at a successful end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted in 2018. The Company initiated its …
Outlook Therapeutics (NASDAQ:OTLK) reported financial results and business highlights for its fiscal year ended September 30, 2018.
As quoted in the press release:
The Company’s wet AMD clinical program was reviewed at a successful end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted in 2018. The Company initiated its first clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab product candidate, in patients with wet age related macular degeneration (wet AMD). The study is being conducted outside of the U.S. and is designed to serve as the first of two adequate and well controlled studies for wet AMD. The U.S. portion of the second study is expected to begin in early 2019 upon the submission of an investigational new drug (IND) application. If the clinical program is successful, it will support the Company’s plans to submit for regulatory approval in multiple markets in 2020.
The Company appointed two new executives to its leadership team, including Jeff Evanson as Chief Commercial Officer and Terry Dagnon as Chief Operating Officer. Mr. Evanson joins the Company with more than 25 years of commercial expertise, most notably with Novartis (Alcon) between 2010 and 2014 where he was most recently the Vice President and Global Commercial Head of the Pharmaceutical Franchise where he was responsible for all aspects of strategy, portfolio (both internal and external opportunities), global brands, launches and campaigns.
As the Company’s new Chief Operating Officer, Mr. Dagnon brings more than 20 years of regulatory experience with domestic and global investigational and marketing approvals in the pharmaceutical and medical device industries, including serving as the North America Head of Regulatory Affairs at Alcon, a Novartis company. He is also experienced in quality and compliance and working with R&D, marketing, sales, legal, and manufacturing, quality and supply chain organizations.