iHub News
3月前
Ovid Therapeutics secures $60M funding to advance epilepsy drug programsMarch 18, 2026 10:58 AM
IH Market News
Ovid Therapeutics Inc. (NASDAQ:OVID) said Wednesday it has raised $60 million through a private placement to support the continued development of its epilepsy drug candidate OV329, including expanding research into seizures linked to tuberous sclerosis complex and infantile spasms. The biotechnology company, currently valued at about $262 million, has seen its shares climb roughly 337% over the past year and was recently trading around $2.01.The company also released new data from the 7 mg dose cohort of OV329, a GABA-aminotransferase inhibitor. According to Ovid, no treatment-related adverse events were observed. Across both single and multiple ascending dose groups, the study recorded 19 unrelated adverse events, all described as mild and temporary.Ovid plans to begin a Phase 2 randomized, placebo-controlled trial in the second quarter of 2026 to test two dose levels of OV329 in patients with treatment-resistant focal onset seizures. Additional studies are planned, including a proof-of-concept trial targeting seizures associated with tuberous sclerosis complex expected to begin in the fourth quarter of 2026, and a separate study for infantile spasms scheduled for 2027.Meanwhile, the company’s OV4071 program—an oral KCC2 direct activator—has received approval from a Human Research Ethics Committee and acknowledgment from Australia’s Therapeutic Goods Administration. This clearance activates a 30-day window for holders of the company’s Series A Warrants to exercise their options, which expire on April 17, 2026. If all warrants are exercised, Ovid could receive up to $53.9 million in additional gross proceeds.As of December 31, 2025, Ovid reported $90.4 million in cash, cash equivalents and marketable securities, which it believes will be sufficient to fund operations into late 2028. If the outstanding warrants are fully exercised, the company said its financial runway could extend into 2029.The private placement includes the issuance of 19,154,321 common shares priced at $2.01 each, along with pre-funded warrants allowing investors to purchase up to 10,701,710 additional shares at $2.009 per warrant.For the fourth quarter ended December 31, 2025, Ovid reported net income of $9.7 million, compared with a net loss of $9.3 million in the same period a year earlier. The quarterly profit was largely driven by a $21 million gain tied to a revaluation of a long-term equity investment. Despite the positive quarter, the company remains unprofitable over the past 12 months, reporting a loss per share of $0.50, and analysts do not expect profitability this year.In other developments, Ovid recently announced the $60 million private investment in public equity (PIPE) financing led by Point72, with participation from existing investors including Adage Capital Management and RA Capital Management. The company intends to use the funds to accelerate its pipeline development.Ovid also reported encouraging results from a Phase 1 trial of OV350, described as the first KCC2 direct activator tested in humans. The study met its primary safety and pharmacokinetic goals and reported no serious treatment-related adverse events. Conducted with 16 healthy volunteers, the trial demonstrated a favorable safety profile, marking another step forward in the company’s clinical development efforts.Ovid Therapeutics stock price
Original: Ovid Therapeutics secures $60M funding to advance epilepsy drug programs
INV4
8月前
Ovid reports positive Phase I data for epilepsy therapy OV329
Oct 6, 2025
Ovid Therapeutics has released positive topline data from its Phase I trial involving healthy volunteers, evaluating OV329, a next-generation gamma-aminobutyric acid (GABA)-aminotransferase (GABA-AT) inhibitor under development for drug-resistant epilepsy.
The trial focused on assessing the pharmacodynamics, pharmacokinetics, tolerability and safety of the therapy, revealing inhibitory activity and a potential safety profile.
Ovid Therapeutics chairman and CEO Dr Jeremy Levin said: “OV329 was designed to deliver the benefits of a novel GABA-AT inhibitor while avoiding the challenges of existing medicines.
“Our Phase I trial generated the first-in-human data, supported by what we believe is the most extensive biomarker programme in early seizure drug development, showing consistent results across multiple validated measures and demonstrating a clean ocular and overall safety profile.”
The study assessed OV329 in 68 healthy participants, comprising 51 individuals receiving the active treatment and 17 receiving a placebo, across both multiple and single ascending dose cohorts.
Doses ranging from 1mg to 5mg were tested as part of the trial, safety assessments of which included ophthalmic evaluations.
Comprehensive exploratory biomarker analyses were performed in the 3mg and 5mg multiple ascending dose cohorts.
These analyses utilised transcranial magnetic stimulation, as measured by electromyography, to implement established metrics for assessing anti-seizure medications, including long-interval intracortical inhibition and the cortical silent period.
Furthermore, electroencephalography and magnetic resonance spectroscopy were examined to investigate markers of target engagement and inhibitory activity.
OV329 showed a favourable tolerability and safety profile in the trial and all potentially adverse events related to the treatment were observed to be mild and transient.
Additionally, Ovid is planning to launch a Phase IIa randomised placebo-controlled trial of OV329.
This trial, set to be initiated in the second quarter of 2026, will evaluate the therapy in adults with drug-resistant focal onset seizures, with completion anticipated in mid-2027.
Link article
$OVID
INV4
8月前
$2+ 😃
==================
Ovid Therapeutics Announces Pricing of Private Placement Totaling up to $175 Million in Gross Proceeds
Oct 3, 2025
Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today announced that it has entered into a securities purchase agreement for a private investment in public equity (“PIPE”) financing that is expected to result in gross proceeds of up to $175 million to the Company, including initial gross proceeds of approximately $81 million, in each case before placement agent fees and offering expenses. The PIPE financing is expected to close on or about October 6, 2025, subject to satisfaction of customary closing conditions.
The PIPE financing included participation from new investors Janus Henderson Investors, RA Capital Management, Eventide Asset Management, Coastlands Capital, Blue Owl Healthcare Opportunities, Balyasny Asset Management, Saturn V Capital and Ally Bridge Group, alongside existing investors including ADAR1 Capital Management and Affinity Healthcare Fund, LP, as well as new and existing large investment management firms.
Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of (i) 57,722 shares of its Series B non-voting convertible preferred stock (the “Series B Preferred Stock”), (ii) Series A warrants (the “Series A Warrants”) to purchase 38,481,325 shares of its common stock and/or pre-funded warrants (the “Pre-Funded Warrants”) and (iii) Series B warrants to purchase 28,861,000 shares of its common stock and/or Pre-Funded Warrants (the “Series B Warrants”). Each share of Series B Preferred Stock is being sold together with a Series A Warrant to purchase 666.66 shares of common stock and/or Pre-Funded Warrants (rounded down to next whole share based on each investor’s aggregate purchase) and a Series B Warrant to purchase 500 shares of common stock and/or Pre-Funded Warrants, referred to collectively as a “Security.” The Security will be sold at a purchase price of $1,400.00 per Security. The Series A Warrants and Series B Warrants will each have an exercise price of $1.40 per share.
The shares of Series B Preferred Stock are convertible into an aggregate of 57,722,000 shares of the Company’s common stock, with each share of Series B Preferred Stock being convertible into 1,000 shares of common stock, subject to the approval of the Company’s stockholders and certain beneficial ownership limitations set by each holder.
The Series A Warrants will be exercisable following receipt of approval by the Company’s stockholders and will terminate upon the earlier of (a) the 30th calendar day following the date on which the Company publicly announces the clearance of the first of any investigational new drug application, clinical trial application or other foreign equivalent with respect to the clinical development of the Company’s OV4071 product candidate and (b) October 6, 2030. The Series B Warrants will be exercisable following receipt of Ovid stockholder approval and will terminate on October 6, 2030, subject to the mandatory exercise requirement, which requires the holder to exercise of Series A Warrants upon achievement of certain stock trading prices of the Company’s common stock. Subject to the satisfaction of the applicable conditions precedent and assuming the exercise of all the Series A Warrants and Series B Warrants for cash, the Company will receive aggregate gross proceeds of $94.3 million. Assuming the satisfaction of the applicable conditions precedent, the conversion of all shares of Series B Preferred Stock and the exercise of all of the Series A Warrants and Series B Warrants for cash, the Company will issue an aggregate of 125,064,325 shares of its common stock in connection with the PIPE financing.
The Company intends to use the net proceeds from the initial closing of the PIPE financing, together with the Company’s existing cash, cash equivalents and marketable securities, to provide financing for research and development, general corporate expenses, and working capital needs. The Company expects that its cash will fund its operating plan into 2028.
TD Cowen, Leerink Partners and Oppenheimer & Co. are acting as joint placement agents for the PIPE financing.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, Ovid and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issuable upon conversion of the Series B Preferred Stock and the shares of common stock issuable upon exercise of each of the Series A Warrants, the Series B Warrants and/or Pre-Funded Warrants, in each case sold in the PIPE financing.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Ovid Therapeutics
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. The Company is advancing a pipeline of novel, targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; OV350, OV4071 and others within a library of compounds that directly activate the KCC2 transporter, for multiple CNS disorders.
https://investorshub.advfn.com/stock-market/NASDAQ/ovid-therapeutics-OVID/stock-news/96944695/ovid-therapeutics-announces-pricing-of-private-pla
=================
Ovid announces positive topline results for the next-generation GABA-aminotransferase inhibitor, OV329, that demonstrate strong inhibitory activity and a potential best-in-category safety profile
Oct 3, 3025
Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today announced positive topline results from its Phase 1 healthy volunteer study evaluating the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) activity of OV329, a next generation GABA-aminotransferase (GABA-AT) inhibitor being developed for drug-resistant epilepsies.
“OV329 was designed to deliver the benefits of a novel GABA-AT inhibitor while avoiding the challenges of existing medicines. Our Phase 1 trial generated the first-in-human data, supported by what we believe is the most extensive biomarker program in early seizure drug development, showing consistent results across multiple validated measures and demonstrating a clean ocular and overall safety profile,” said Dr. Jeremy Levin, DPhil, MB BChir, chairman and chief executive officer of Ovid Therapeutics. “We believe these results reinforce OV329’s therapeutic potential, and we are excited to advance it further in development alongside our rapidly progressing KCC2 direct activator portfolio, as we continue our commitment to developing innovative therapies for patients that address diseases and symptoms caused by excessive neural excitation.”
“The results from this study provide unequivocal evidence that support the advancement of OV329 into further studies in patients with epilepsy,” said Alexander Rotenberg, MD, PhD, Director of Neuromodulation at Boston Children’s Hospital, professor of neurology at Harvard Medical School, and world-leading expert in the application of TMS biomarkers for the study of ASMs. “These early data confirm that OV329 is getting into the brain and exerting concentration-dependent inhibition, as shown by the highly significant correlation between OV329 blood exposure and long-interval intracortical inhibition (LICI).”
TRIAL DESIGN
The Phase 1 trial evaluated OV329 in 68 healthy volunteers, including 51 participants taking active treatment and 17 participants receiving placebo, across single and multiple ascending dose cohorts. Doses tested ranged from 1 mg – 5 mg. The study assessed safety, tolerability, pharmaco-kinetic and pharmacodynamic activity, with safety evaluations including rigorous ophthalmic evaluations. Extensive exploratory biomarker analyses were conducted in the 3 mg (active n=6; pbo n=2) and 5 mg (active n=15; pbo n=5) MAD cohorts. These analyses leveraged transcranial magnetic stimulation (TMS) as measured with electromyography (EMG) to apply established measures for evaluating anti-seizure medicine such as LICI and the cortical silent period (CSP), which have been previously used to assess the inhibition of therapeutic doses of vigabatrin (VGB).1,2,3 All TMS biomarkers were studied across two muscle groups; including the first dorsal interosseous (FDI), a muscle in the hand located between the thumb and index finger and the abductor pollicis brevis (APB), a thumb muscle at the base of the palm.
Additionally, magnetic resonance spectroscopy (MRS) and electroencephalography (EEG) were studied to explore markers of target engagement and inhibitory activity, respectively. MRS measured GABA levels in the medial parietal lobe and EEG assessed brainwave activity.
Active participants received OV329 via a once-daily oral capsule at 3 mg or 5 mg doses. All biomarker results compared participant findings from their pre-treated baseline on Day 1 to their post-treatment findings on Day 7 and relative to placebo. Where methods were reproduceable, OV329 outcomes were compared to previously published studies of VGB as measured in healthy volunteers at confirmed therapeutic doses.
https://investorshub.advfn.com/stock-market/NASDAQ/ovid-therapeutics-OVID/stock-news/96944602/ovid-announces-positive-topline-results-for-the-ne
$OVID
Hot Features
プレミアム
登録してリアルタイムのアラート、カスタムポートフォリオ、市場の動きを入手してください。
glenn1919
2月前
KeepOn
8月前
Monksdream
2年前
RNsidersbuying
5年前
MfridgeV2
5年前
ClayTrader
5年前
Actualfactual
5年前
FROZENFLAME
5年前
stoner422
6年前
メールアドレスで登録
