Saturday, November 02, 2019 5:56:16 PM
2. I reviewed the company's updated presentation. The last time I'd looked, they'd been guiding for Fragile X readout in Q4 or close to year end (perhaps the riskiest but least impactful of the 4 expected readouts over the next year). However, now they are guiding for it in early 2020 and I remind members that the ARCADE readout for soticlestat in CDKL5 Deficiency Disorder / Dup15q Syndrome is expected in Q1. I have higher conviction for this second readout, considering promising results we reviewed previously for the ENDYMION open label extension trial.
Given this change, to my eyes it makes it less feasible to wait for the Fragile X readout to get in prior to ARCADE. As preclinical rationale for OV101 appears intriguing and data in FXS mice has shown normalization of certain aspects of Fragile X (anxiety, irritability, repetitive behaviors, hyperactivity), I don't mind being exposed to both readouts (with Angelman to follow midyear).
Market capitalization of around $125 million seems quite reasonable relative to substantial market opportunities being targeted and multi-faceted neurology pipeline (cash position boosted by secondary as well). This is primarily a catalyst idea, as several data events loom in the near to medium term (OV101 in Fragile X and Angelman, soticlestat in phase 2 ARCADE study and phase 2 ELEKTRA trial). OV101 is the only drug in development for Angelman Syndrome, and management appears to have much confidence in achieving the same CGI-I endpoint as the prior mid-stage study (FDA gave them green light to file for registration if they can do so). Soticlestat, 50-50 partnered with Takeda, has a unique mechanism of action that not only crushes seizures but also potentially heals the brain. The asset is both first-in-class and only-in-class, is targeting a large opportunity in rare epilepsies, and has shown impressive seizure reduction in prior trials (caveat for low N). ENDYMION extension data provided another element of derisking as a group of incredibly difficult to treat patients experienced increased seizure reduction with prolonged treatment. See my September article. Time Frame For Upside = 6 to 12 months as multiple data readouts come to pass (Catalyst Idea).
Recent OVID News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/11/2024 09:38:01 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 09/11/2024 09:36:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/11/2024 08:57:01 PM
- Meg Alexander Takes on Expanded Role as President and COO at Ovid Therapeutics, Strengthening Leadership for Future Growth • GlobeNewswire Inc. • 09/11/2024 12:00:00 PM
- Ovid Therapeutics to Present at Upcoming September Investor Conferences • GlobeNewswire Inc. • 09/04/2024 12:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 12:03:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 12:02:49 PM
- Ovid Therapeutics Reports Business Updates and Second Quarter 2024 Financial Results • GlobeNewswire Inc. • 08/13/2024 12:00:00 PM
- Ovid Therapeutics Appoints Dr. Amanda Banks, Experienced Biotech Leader & Physician as Chief Development Officer • GlobeNewswire Inc. • 08/08/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 09:22:46 PM
- Ovid Therapeutics to Present at Upcoming August Investor Conferences • GlobeNewswire Inc. • 07/30/2024 12:00:00 PM
- Ovid Therapeutics Expands Scientific Advisory Board with Appointments of Leading Neurologists, Neuroscientists and Epileptologists • GlobeNewswire Inc. • 07/23/2024 12:00:00 PM
- eNeuro Publishes Findings on the Anti-Convulsant Properties of OV329 and Its Potential Effectiveness in Treatment-Resistant Seizures • GlobeNewswire Inc. • 07/10/2024 12:00:00 PM
- Ovid Therapeutics and Graviton Bioscience Announce Topline Data from a Phase 1 Clinical Trial Studying OV888/GV101 Capsule, a Potential First-In-Class Therapy for Cerebral Cavernous Malformations • GlobeNewswire Inc. • 07/01/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 11:10:10 AM
- Ovid Therapeutics Reports on Takeda’s Announcement of Phase 3 Topline Study Results for Soticlestat • GlobeNewswire Inc. • 06/17/2024 10:55:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:22:06 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/14/2024 09:19:51 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 12:11:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 12:03:02 PM
- Ovid Therapeutics Reports Business Updates and First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/14/2024 12:00:00 PM
- Ovid Therapeutics to Present at the H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/13/2024 11:00:00 AM
- Ovid Therapeutics to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/04/2024 12:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/08/2024 01:24:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/08/2024 01:20:05 PM
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