NEW YORK - Takeda Pharmaceutical Company (NYSE:TAK) Limited and Ovid Therapeutics (NASDAQ:OVID) Inc. disclosed mixed results from their Phase 3 clinical trials for soticlestat, a treatment for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), two rare forms of epilepsy. The SKYLINE study for DS narrowly missed its primary endpoint, while the SKYWAY study for LGS failed to meet its primary goal.
In the SKYLINE trial, soticlestat, when added to standard care, did not achieve a statistically significant reduction in convulsive seizure frequency compared to placebo. However, it showed significant effects in multiple secondary efficacy endpoints, including responder rate and improvements in caregiver and clinician global impression, with p-values ≤ 0.008.
The SKYWAY trial, which focused on LGS, did not see a reduction in major motor drop seizure frequency with soticlestat compared to placebo. Despite these outcomes, the drug maintained a consistent and favorable safety and tolerability profile across both studies.
Following the sale of rights back to Takeda three years ago, Ovid Therapeutics has been building a pipeline with novel programs. These include two clinical programs, OV888 entering Phase 2 and OV329 completing a Phase 1 with efficacy biomarkers, and a preclinical program, OV350, expected to move into the clinic in 2025.
Ovid's cash runway is projected to last into the first half of 2026, during which several clinical milestones are anticipated. The company's strategy is to advance its pipeline with financial discipline, independent of soticlestat's outcomes.
The unmet need in DS and LGS remains significant, with approximately 85% of individuals with these conditions continuing to experience refractory seizures and other challenges despite available treatments. Soticlestat's novel mechanism of action and lack of clinically meaningful drug-to-drug interactions had positioned it as a potential breakthrough therapy.
This article is based on a press release statement and provides a summary of the recent developments in the clinical trials of soticlestat for the treatment of rare epilepsies.
In other recent news, Ovid Therapeutics has been making significant strides in its development journey. BTIG has maintained a Buy rating and an $11.00 price target for the company, following insights gained from discussions with experts in the field. The company's approach to drug development, particularly the unique characteristic of its molecules that do not directly bind to GABA receptors, remains a key point of interest for BTIG.
Oppenheimer, meanwhile, has reiterated an Outperform rating and a price target of $8.00, following Ovid's first-quarter 2024 financial results. The company reported earnings per share (EPS) of ($0.17), surpassing the anticipated ($0.24) and ($0.22) projected by Oppenheimer and consensus estimates, respectively.
Ovid has completed Phase 3 trials for Soticlestat in treating Dravet Syndrome and Lennox-Gastaut Syndrome, with top-line readout expected by September 2024. These developments, along with the company's progress in developing its pipeline, including treatments such as OV888, OV329, and OV350, have contributed to Oppenheimer's positive outlook for the company.
InvestingPro Insights
Ovid Therapeutics Inc . has shown resilience in its share performance, with a 20.96% return over the last three months, which is a positive sign for investors amidst the recent clinical trial setbacks. This aligns with the "InvestingPro Tips" that highlight the company's strong return in the short term. Additionally, Ovid's financial health seems sturdy with more cash than debt on its balance sheet, an important metric for investors considering the company's ability to fund ongoing research and development without the immediate need for external financing.
Investors should note, though, that Ovid is trading at a high revenue valuation multiple, and analysts do not expect the company to be profitable this year. These factors, combined with the "InvestingPro Tips" pointing out the company's quick cash burn and anticipation of a sales decline, could suggest caution for those looking at the long-term picture.
For those interested in a deeper dive into Ovid's financials and future outlook, there are additional "InvestingPro Tips" available that could provide further insights into investment decisions. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
InvestingPro Data metrics further inform us about the company's financial situation:
- Market Cap (Adjusted): $233.41M USD
- P/E Ratio (Adjusted) for the last twelve months as of Q1 2024: -4.47
- Revenue Growth for the last twelve months as of Q1 2024: 283.93%
These metrics, particularly the substantial revenue growth, could be indicative of the company's potential to overcome current challenges and capitalize on future opportunities in its pipeline. Keep in mind that Ovid does not pay dividends, which is typical for companies focused on growth and reinvestment into their business.
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