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Jun 30, 2020
Ovid Therapeutics Q2 2020 Earnings Report
Reported financial results for the second quarter and provided a corporate update.
Key Takeaways
Ovid Therapeutics reported its second quarter 2020 financial results, highlighting the completion of enrollment in the pivotal Phase 3 NEPTUNE trial with OV101 in Angelman syndrome and the upcoming data readouts for soticlestat. The company also entered an exclusive license agreement with Angelini Pharma for OV101 in Europe and received Rare Pediatric Disease Designation from the FDA for OV101 in Angelman syndrome.
Completed enrollment in the pivotal Phase 3 NEPTUNE trial with OV101 in Angelman syndrome; topline results expected in Q4 2020.
Multiple data readouts for soticlestat expected in Q3 2020, including from the randomized Phase 2 ELEKTRA trial in Dravet syndrome and Lennox-Gastaut syndrome, the Phase 2 ARCADE trial in CDKL5 deficiency disorder and Dup15q syndrome and the ENDYMION open-label extension study.
Received Rare Pediatric Disease Designation by the FDA for OV101 for the treatment of Angelman syndrome, which if approved by the FDA can result in a priority review voucher.
Entered into an exclusive license agreement with Angelini Pharma to develop, manufacture and commercialize OV101 for the treatment of Angelman syndrome in Europe.
Ovid Therapeutics
Ovid Therapeutics
Forward Guidance
Ovid anticipates several clinical data readouts and continues to advance its pipeline and collaborations.
Positive Outlook
- Topline results from the Phase 3 NEPTUNE trial of OV101 in Angelman syndrome are expected in the fourth quarter of 2020.
- Data from the Phase 2 ARCADE trial in CDKL5 deficiency disorder (CDD) and Dup15q syndrome are expected in the third quarter of 2020.
- Results from the randomized Phase 2 ELEKTRA trial in patients with Dravet syndrome and Lennox-Gastaut syndrome (LGS) are expected in the third quarter of 2020.
- Updated data from the ENDYMION open-label extension study are expected in the third quarter of 2020.
- Ovid is planning to hold a second educational webinar early in the fourth quarter of 2020 to review the Company’s OV101 development program for Angelman syndrome and Fragile X syndrome.
Challenges Ahead
- Uncertainties in the development and regulatory approval processes.
- Initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials.
- The risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available.
- Potential impact of the COVID-19 pandemic on Ovid’s business and the global economy.
- Ovid assumes no obligation to update any forward-looking statements.