"Our first fiscal quarter of 2023 continued to demonstrate solid execution toward the potential commercialization of ONS-5010. With the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023, and review of our MAA in the EU underway with a decision date expected in early 2024, we are well on our way toward our goal of becoming a commercial-stage company," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "Looking ahead, we remain focused on execution and positioning ourselves for a commercial launch of ONS-5010 to enhance the standard of care in the retinal anti-VEGF space."
Published first on TheFly
See the top stocks recommended by analysts >>
Read More on OTLK:
- Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update
- Outlook Therapeutics® to Present at the SVB Securities Global Biopharma Conference
- Outlook Therapeutics initiated with an Overweight at Cantor Fitzgerald
- Outlook Therapeutics appoints Surendra Sharma as SVP, medical affairs
- Outlook Therapeutics® Strengthens Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs and Glen Olsheim, Executive Director of Commercial Excellence
