Key Takeaways Ovid Therapeutics rallies 39.2% after upbeat phase I study data for its epilepsy candidate, OV329.OV329 showed strong GABAergic activity, increasing neural inhibition and boosting brain GABA levels.The therapy was well tolerated, and OVID plans a phase IIa study in drug-resistant focal onset seizures.Shares of Ovid Therapeutics (OVID) rallied 39.2% primarily driven by the encouraging top-line data readout from an early-stage study of the company’s lead investigational candidate, OV329.The cand ...

Core Viewpoint - Ovid Therapeutics Inc. has announced a private investment in public equity (PIPE) financing expected to generate gross proceeds of up to $175 million, with an initial closing of approximately $81 million to support its operating plan and clinical pipeline through 2028 [1][6]. Financing Details - The PIPE financing is anticipated to close around October 6, 2025, pending customary closing conditions [1]. - New investors participating in the PIPE include Janus Henderson Investors, RA Capital Management, and others, alongside existing investors [2]. - The company is selling 57,722 shares of Series B non-voting convertible preferred stock, Series A warrants for 38,481,325 shares of common stock, and Series B warrants for 28,861,000 shares of common stock [3]. Securities Structure - Each share of Series B Preferred Stock is convertible into 1,000 shares of common stock, subject to stockholder approval and ownership limitations [4]. - Series A and Series B Warrants have an exercise price of $1.40 per share and will be exercisable following stockholder approval [5]. Use of Proceeds - The net proceeds from the PIPE financing will be used for research and development, general corporate expenses, and working capital needs, with expectations to fund operations into 2028 [6]. Company Overview - Ovid Therapeutics is focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline that includes OV329 for treatment-resistant seizures and other compounds targeting CNS disorders [10].

Core Insights - Ovid Therapeutics Inc. announced positive topline results from its Phase 1 study of OV329, a next-generation GABA-aminotransferase inhibitor aimed at treating drug-resistant epilepsies, demonstrating a favorable safety and tolerability profile [1][2][6] Trial Design - The Phase 1 trial involved 68 healthy volunteers, with 51 receiving active treatment and 17 receiving placebo, testing doses from 1 mg to 5 mg [3] - Safety, tolerability, pharmacokinetic, and pharmacodynamic activities were assessed, including rigorous ophthalmic evaluations and extensive exploratory biomarker analyses [3][4] Biomarker and Efficacy Results - OV329 showed significant GABAergic inhibition, with a 53% increase in inhibition at the 5 mg dose as measured on the abductor pollicis brevis muscle [8] - The study confirmed OV329's ability to penetrate the brain and engage its target, achieving biological modulation consistent with elevated GABA levels [4][8] - After 7 days of dosing at 5 mg, mean GABA levels increased by 7.13% in the medial parietal lobe compared to 0.24% in placebo [8] Safety and Tolerability - The safety profile of OV329 was favorable, with all treatment-related adverse events reported as mild and transient, and no evidence of ophthalmic or retinal changes observed [6][9] - Extensive ophthalmic tests showed no adverse effects, contrasting with existing treatments like vigabatrin, which can accumulate in the retina [6] Future Development Plans - Ovid plans to advance OV329 into a Phase 2a study for drug-resistant focal onset seizures, expected to start in Q2 2026 [10] - The company is also progressing its KCC2 direct activator portfolio, with several regulatory and clinical milestones anticipated in the next 12 months [10][11]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours gains on October 1, driven by technical momentum and recent clinical updates rather than new disclosures [1] Company Summaries - Zhongchao Inc. (ZCMD) saw a 14.04% increase in after-hours trading, rising to $1.30 from $1.14, despite no new filings or press releases [2] - AbCellera Biologics Inc. (ABCL) rose 11.41% in after-hours trading, closing at $6.64, following an 18.49% gain during the regular session, attributed to recent clinical trial progress [3][4] - Vor Biopharma Inc. (VOR) surged 9.53% in after-hours trading, recovering from a 19.42% drop during the regular session, with no new updates since a recent announcement regarding clinical data presentation [5] - Incannex Healthcare Inc. (IXHL) gained 6.48% in after-hours trading, partially recovering from a 6.94% drop, with the latest update showing positive Phase 2 trial results for PSX-001 [6] - Ovid Therapeutics Inc. (OVID) shares rose 8.03% in after-hours trading, building on a 5.38% gain during the regular session, with recent earnings report indicating a narrower net loss and higher revenue [7] - Bullfrog AI Holdings Inc. (BFRG) advanced 3.44% in after-hours trading, following a 3.57% rise during the regular session, after announcing an expansion of its sales and marketing team [8]

Core Insights - Biotech stocks experienced strong after-hours gains, driven by Pfizer's announcement of U.S. drug price cuts and a $70 billion investment in domestic manufacturing [1] Group 1: Ovid Therapeutics Inc. (OVID) - Ovid Therapeutics saw a 7.69% increase in after-hours trading, reaching $1.40 after a regular session decline of 7.14% to $1.30 [2] - The stock's regular session selloff was marked by elevated trading volume of over 2.93 million shares, significantly above the average of 2.07 million shares [2] - Recent coverage from Lucid Capital initiated a Buy rating with a price target of $5.50, highlighting Ovid's pipeline assets in Phase 1 trials for drug-resistant epilepsies [3] Group 2: NeuroOne Medical Technologies Corp. (NMTC) - NeuroOne Medical Technologies rose 6.98% in after-hours trading to $0.9506 after a modest decline of 1.27% during the regular session [4] - The trading volume was relatively light at 134,720 shares, below the average of 315,000 shares [4] - The company announced a virtual roadshow webinar scheduled for October 7 to discuss operations and recent FDA clearance [5] Group 3: PepGen Inc. (PEPG) - PepGen experienced a 3.03% rise in after-hours trading, reaching $4.76 after closing at $4.62 [6] - The stock has surged over 120% in the past week due to positive clinical and financial updates [6] - A recent $100 million public offering was completed, expected to support the development of PGN-EDODM1 and PGN-EDO51 [9] Group 4: Reviva Pharmaceuticals Holdings Inc. (RVPH) - Reviva Pharmaceuticals rose 5.81% in after-hours trading to $0.3900 after a 19.56% surge during the regular session [10] - The trading volume was significantly elevated at over 26 million shares, well above the average of 3.9 million shares [10] - The company recently announced a $9 million public offering priced at $0.30 per share [11] Group 5: Anika Therapeutics Inc. (ANIK) - Anika Therapeutics saw a 5.53% increase in after-hours trading, reaching $9.92 after closing at $9.40 [11] - The stock's regular session strength followed a quiet news cycle, with no new filings or press releases [12] - Anika is in focus ahead of its scheduled earnings report on October 30, 2025 [12]

Core Insights - Several small-cap stocks experienced significant gains in after-hours trading due to corporate updates, clinical developments, and strategic shifts Company Summaries MEDIROM Healthcare Technologies Inc. (MRM) - Shares surged 282.8% to $5.55 after announcing plans to double the installation of its biometric authentication device "Orb" to 200 stores in collaboration with "World" [2] - Closed at $1.45 during regular trading, down 7.05%, with a trading volume of over 31.5 million shares [3] - The stock has a 52-week range of $0.34 to $5.30, highlighting the scale of its overnight move [3] Lexaria Bioscience Corp. (LEXX) - Shares rose 45.75% to $2.23 following renewed interest in its DehydraTECH drug delivery platform, which enhances GLP-1 drug delivery [4] - Closed at $1.53, up 7.75%, with a volume exceeding 7.5 million shares [5] - The stock's 52-week range is $0.775 to $3.392, with Thursday's close near the midpoint [5] Safety Shot, Inc. (SHOT) - Shares increased 12% to $0.28 after announcing a partnership with Monarq Asset Management to manage its BONK Holdings Treasury [6] - Closed at $0.25, down 9.06%, with a trading volume of over 15.4 million shares [7] - The stock has a 52-week range of $0.23 to $1.35, with the after-hours price near the lower end [7] Aquestive Therapeutics, Inc. (AQST) - Shares rose 11.41% to $5.86 following favorable regulatory news regarding its oral epinephrine candidate, Anaphylm [8] - Closed at $5.26, down 2.95%, with a volume of over 3.6 million shares [9] - The stock's 52-week range is $2.12 to $6.00, with the after-hours price near the upper end [9] Ovid Therapeutics Inc. (OVID) - Shares increased 4.26% to $1.47 after reaching a 52-week high during regular trading, driven by progress in its neurological pipeline [10] - Closed at $1.41, up 0.71%, with a trading volume of over 2.4 million shares [11] - The stock has a 52-week range of $0.2430 to $1.47, with Thursday's close at the top end of its recent performance band [11]

Core Insights - Ovid Therapeutics Inc. reported business updates and financial results for Q2 2025, highlighting advancements in its drug pipeline and financial performance [1][19]. Pipeline and Business Updates - The company is advancing its pipeline with key readouts expected soon, including Phase 1 data for OV329, a potential treatment for conditions driven by excess neuronal excitation [2][3]. - OV329 is designed to be a safer GABA-aminotransferase inhibitor, aiming to replace vigabatrin, which has serious safety concerns [4][5]. - The Phase 1 study for OV329 is on track for topline results in late Q3 2025, with plans for a Phase 2a trial in adults with treatment-resistant focal onset seizures [9][16]. - Ovid is also progressing its KCC2 direct activator programs, with OV350's safety data expected in Q4 2025 and OV4071's first-in-human studies anticipated in early 2026 [10][11][12]. Financial Performance - As of June 30, 2025, Ovid had cash, cash equivalents, and marketable securities totaling $38.3 million, expected to support operations into early H2 2026 [7][22]. - Revenue from royalty agreements increased to $6.3 million in Q2 2025, compared to $169,000 in the same period of 2024 [22]. - Research and development expenses decreased to $6.5 million in Q2 2025 from $12.6 million in Q2 2024, reflecting organizational restructuring [22]. - The company reported a net loss of $4.7 million for Q2 2025, compared to a net income of $8.5 million in Q2 2024 [22]. Strategic Developments - Ovid entered a $7.0 million agreement with Immedica Pharma AB to monetize ganaxolone royalties, strengthening its balance sheet and extending its operational runway [14][15]. - The company plans to explore strategic options to accelerate development and offset costs, including partnerships and monetizing intellectual property [17][18].

Company Overview - Ovid Therapeutics Inc. is a biopharmaceutical company based in New York, focused on developing small molecule medicines for brain conditions with significant unmet needs [2] - The company is advancing a pipeline of novel, targeted small molecule candidates that address neuronal hyperexcitability associated with various neurological and neuropsychiatric disorders [2] Product Pipeline - Ovid is developing OV329, a next-generation GABA-aminotransferase inhibitor, aimed at treating treatment-resistant seizures and other undisclosed indications [2] - The company is also working on OV350, OV4071, and additional compounds that activate the KCC2 transporter for multiple central nervous system disorders [2] Upcoming Events - Company management will participate in the BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025 [1]

Core Viewpoint - Ovid Therapeutics has entered into a definitive agreement with Immedica Pharma for the sale of future royalties related to ganaxolone sales outside of China, providing Ovid with a non-dilutive capital infusion of $7 million to support its ongoing operations [1][2]. Group 1: Transaction Details - Immedica will pay $7 million in cash to acquire 100% of the royalty rights held by Ovid, enhancing Immedica's focus on ganaxolone by gaining control of additional intellectual property rights [1]. - The transaction includes royalties associated with a previous agreement Ovid had with Marinus Pharmaceuticals regarding ganaxolone for CDKL5 deficiency disorder [4]. - Ovid recorded approximately $566,000 in ganaxolone royalty revenues in 2024, indicating the current revenue scale from this asset [2]. Group 2: Company Backgrounds - Ovid Therapeutics is a biopharmaceutical company focused on developing small molecule medicines for brain conditions with significant unmet needs, advancing a pipeline of novel candidates targeting neurological disorders [7]. - Immedica is a pharmaceutical company dedicated to the commercialization of medicines for rare diseases, with a global distribution network serving patients in over 50 countries [6].

Core Insights - Ovid Therapeutics Inc. is hosting an event on June 12, 2025, to discuss the application of biomarkers in epilepsy and the pharmacodynamic activity of its OV329 program [1][2] - The event will feature Dr. Alexander Rotenberg, a leading expert in neurology, who will discuss the emerging use of biomarkers in anti-seizure medicine development [1][3] Company Overview - Ovid Therapeutics is focused on developing small molecule medicines for brain conditions with significant unmet needs, including treatment-resistant epilepsy [5] - The company is advancing a pipeline that includes OV329, a next-generation GABA-aminotransferase inhibitor designed to provide a novel approach for patients with treatment-resistant seizures [3][5] Clinical Development - OV329 is currently completing a Phase 1 study that evaluates its effects on pharmacodynamic biomarkers, safety, tolerability, and pharmacokinetics [3] - The program is expected to have a topline readout in Q3 2025, indicating progress in its clinical development [2]