The Phase 1 study for OV888/GV101 capsule met its objective, demonstrating a favorable safety and tolerability profile with no serious adverse events Secondary endpoint results indicate that the target pharmacokinetic profile was achieved at the targeted clinical dose, supporting once daily dosing OV888/GV101 capsule was shown to be biologically active in participants and elicited dose-dependent pharmacodynamic effects within the planned therapeutic dose range A Phase 2 study for the treatment of cerebral c ...

NEW YORK, June 30, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ovid Therapeutics Inc. ("Ovid" or the "Company") (NASDAQ: OVID). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. [Click here for information about joining the class action] On this news, Ovid's stock price fell $2.50 per share, or 75.99%, to close at $0.79 per share on June 17, 2024. Attorney advertising. Prior results do not guarantee similar ...

CONTACT: Danielle Peyton Pomerantz LLP dpeyton@pomlaw.com 646-581-9980 ext. 7980 NEW YORK, June 22, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ovid Therapeutics Inc. ("Ovid" or the "Company") (NASDAQ: OVID). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Ovid and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practic ...

Shares of Ovid Therapeutics (OVID) plunged 76% on Monday after it announced that treatment with soticlestat, its Takeda (TAK) -partnered investigational epilepsy drug, failed to meet the primary endpoint of two pivotal late-stage studies. Image Source: Zacks Investment Research Ovid's partner Takeda evaluated soticlestat for treating two rare and severe forms of epilepsy, namely Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), in the late-stage SKYLINE and SKYWAY studies, respectively. While the SKYL ...

Takeda Pharmaceutical Company Limited announced the results of its trial of soticlestat as a treatment for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). The bad news is that the treatment narrowly missed its primary endpoints in both of these cases. Dr. Jeremy Levin, chairman and CEO of Ovid Therapeutics, said the following about the news. Heavy trading is pulling down OVID stock on Monday. That has more than 13 million shares changing hands as of this writing. This is well above the company's dai ...

"After selling our rights back to Takeda three years ago, we have built an exciting and differentiated pipeline, which we believe will generate multiple value-creating opportunities in the near-term. Our R&D and financial strategy is independent of soticlestat's outcome. We will advance our pipeline thoughtfully and continue to apply the fiscal discipline to achieve our goals," remarked Dr. Levin. Takeda's Skyline study in Dravet syndrome narrowly missed its primary endpoint of reduction in convulsive seizu ...

Ovid Therapeutics (OVID) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 26.09%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.22, delivering a surprise of -29.41%. Over the last four quarters, the company has sur ...

Financial Performance - Total revenue for the three months ended March 31, 2024, was $148,000, an increase of 124% compared to $66,000 for the same period in 2023[142] - The net loss for the three months ended March 31, 2024, was $11.7 million, a decrease of 12.5% compared to a net loss of $13.4 million for the same period in 2023[142] - The company recorded other income of $5.7 million for the three months ended March 31, 2024, compared to $1.5 million for the same period in 2023[142] - General and administrative expenses decreased to $7.2 million for the three months ended March 31, 2024, down from $8.3 million in 2023, reflecting a reduction in force and strategic cost-reduction initiatives[145] - The company recorded net losses of approximately $11.7 million for the three months ended March 31, 2024, compared to $13.4 million for the same period in 2023, with an accumulated deficit of $289.6 million[148] - Net cash used in operating activities was $16.7 million for the three months ended March 31, 2024, compared to $12.1 million in 2023, reflecting a net loss offset by non-cash charges[155] - The company anticipates continued losses and negative operating cash flows for at least the next several years, with no products approved for commercial sale to date[148] Research and Development - Research and development expenses increased to $10.4 million for the three months ended March 31, 2024, from $6.6 million in the same period in 2023, reflecting a 57% increase[142] - Total research and development expenses for the three months ended March 31, 2024, were $10.4 million, an increase of $3.8 million from $6.6 million in the same period of 2023, primarily due to accelerated clinical development expenses[144] - The company expects to submit an investigational new drug (IND) application for its third program in the second half of 2024[122] - The company plans to develop an intravenous formulation of OV329, with an IND application expected in the second half of 2024[130] - The Phase 1 study for OV888 is anticipated to be completed in the first half of 2024, with plans to initiate a signal-finding trial in the second half of 2024[128] Cash and Investments - As of March 31, 2024, the company had total cash, cash equivalents, and marketable securities of $90.3 million, sufficient to fund projected operating expenses for at least the next 12 months[147] - Net cash provided by investing activities was $20.2 million for the three months ended March 31, 2024, down from $30.2 million in 2023, primarily due to the maturity of marketable securities[156] Capital and Debt - The company has raised net proceeds of $275.4 million from the sale of its capital stock as of March 31, 2024[124] - The company has no long-term debt and no material non-cancelable purchase commitments as of March 31, 2024, and has agreed to make milestone payments up to $279.3 million under various license agreements[150] - The company filed a shelf registration statement allowing the sale of up to $250.0 million of common stock, including $75.0 million available under an at-the-market offering program[153] Milestones and Agreements - The company is eligible to receive up to $660 million in regulatory and commercial milestones and tiered royalties up to 20% under the RLT Agreement with Takeda[127]

Ovid pipeline programs are advancing on track. Multiple data and regulatory milestones are expected before year-end. These include: • Takeda has completed two Phase 3 trials studying soticlestat as a treatment for Lennox-Gastaut syndrome and Dravet syndrome; topline data are anticipated in Takeda's H1 2024 fiscal year • A Phase 1, double-blind, multiple-ascending dose trial evaluating OV888 (GV101) is complete; topline safety data are expected in H1 2024 • Ovid expects to initiate a Phase 2 clinical program ...

Wall Street expects a year-over-year decline in earnings on higher revenues when Ovid Therapeutics (OVID) reports results for the quarter ended March 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the st ...