ONS - Oncobiologics, Inc.

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  • GlobeNewswire

    Oncobiologics Changes Name to Outlook Therapeutics; Announces Next Steps in Executing ONS-5010 Clinical and Regulatory Strategy

    Oncobiologics, Inc. (ONS) (the “Company”) today announced several key corporate events that enhance the Company’s ability to advance the development of its lead product candidate, ONS-5010, a proprietary ophthalmic bevacizumab product candidate for the treatment of wet age related macular degeneration (wet AMD). The Company has changed its name from Oncobiologics, Inc. to Outlook Therapeutics, Inc., effective immediately.  The Company will continue to be listed on the Nasdaq Capital Market and its common stock and Series A warrants will begin trading under the ticker symbols “OTLK” and “OTLKW,” respectively, beginning on Tuesday, December 4, 2018.

  • GlobeNewswire

    Oncobiologics Advances ONS-5010 into wet AMD Clinical Trial

    Oncobiologics, Inc. (ONS) today announced that it has begun dosing patients in its first clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab product candidate, in patients with wet age related macular degeneration (wet AMD). This first clinical study for ONS-5010, the Company’s lead product candidate, is being conducted outside of the United States 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 scheduled to begin in early 2019 upon the submission of an investigational new drug (IND) application. 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 earlier in 2018.  If the program is successful, it will support the Company’s plans to submit for regulatory approval in multiple markets in 2020.  The Company is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.

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