Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders. You must click the activation link in order to complete your subscription. Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement . Phathom Pharmaceuticals is a biopharmaceutical company committed to transforming the treatment landscape and improving the lives of patients suffering from acid-related gastrointestinal (GI) disorders. First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older1, ZTALMY significantly reduced major motor seizure frequency in CDD patients in the pivotal Marigold trial, Rare Pediatric Disease Priority Review Voucher awarded to Marinus Pharmaceuticals by the FDA, Marinus to host conference call March 21, at 8:00 a.m. The FDA reviewed ZTALMY under Priority Review and granted ZTALMY orphan drug and Rare Pediatric Disease designations for the treatment of CDD. These stock option grants have an exercise price of $4.23 per share, which is equal to the closing price of the Common Stock on December 8, 2022 (date of grant for such stock options). If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness. Marinus Pharmaceuticals, Inc. To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to two new employees. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. The CDKL5 gene produces a protein that is important for normal brain development and function. 2019 Pediatric Neurology Cytochrome P450 inducers will decrease ganaxolone exposure. Stop by booth #401 to learn more about the work were doing and to say hi! Any forward-looking statements that we make in this press release speak only as of the date of this press release. Ryan, living with CDKL5 deficiency disorder, Dedicated to driving forward innovation for seizure disorders, Maximizing the reach ofour therapeutics to make a difference in patients lives, Engaging with leading epilepsyand seizure disorder patient advocacy groups. Lexicon's LX9211 Shows Significant and Consistent Benefits in the Treatment of Painful Diabetic Neuropathy in Full Results from the Phase 2 RELIEF-DPN-1 Trial Presented at the 16th Annual Pain . #AES2022, Were at the @AmEpilepsySoc's 2022 Annual Meeting alongside fellow industry leaders dedicated to improving outcomes for people with epilepsy. It is recommended that ZTALMY be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation. RADNOR, Pa., November 30, 2022--Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today . You can sign up for additional alert options at any time. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. Devimistat is undergoing multiple clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the . Examples of forward-looking statements contained in this press release include, among others, statements regarding our commercialization plans and the timing thereof; our expectations regarding scheduling by the U.S. Drug Enforcement Administration and the expected timing thereof; our plans to launch a patient assistance program that provides ongoing financial and product support to patients and caregivers; our expectations to monetize the PRV; our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions and product launches for ganaxolone, and the timing thereof; our expectations and beliefs regarding the regulatory authorities with respect to our product candidates; the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives and other future events. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. 3K followers 500+ connections. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Today is a historic milestone not only for Marinus but for CDD patients, families and caregivers who have long been navigating the unpredictable, often devastating reality of living with uncontrolled seizures, said Scott Braunstein, M.D., Chief Executive Officer of Marinus. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. ET to discuss the Marinus ZTALMY Approval and its Fourth Quarter 2021 Business Update. Thanks to our research and this trial, we now have the first treatment specifically approved for seizures associated with CDKL5 deficiency disorder that was shown to have a positive benefit-risk profile. Dr. Demarest is also PI of the International CDKL5 Clinical Research Network and Assistant Professor of Pediatrics-Neurology at the University of Colorado School of Medicine. With the approval, the FDA awarded a Rare Pediatric Disease Priority Review Voucher (PRV), which Marinus plans to monetize. The approval of ZTALMY would not have been possible without the patients, caregivers and investigators who participated in the clinical trials to develop this important new therapy. ZTALMY, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. Lexicon Pharmaceuticals to Participate in the 34th Annual Piper Sandler Healthcare Conference and the 5th Annual Evercore ISI HealthCONx Conference. The entity had 1:4 split on the 23rd of September 2020. Were coming to the @AmEpilepsySoc 2022 Annual Meeting and couldnt be more excited. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. Marinus Pharmaceuticals, which belongs to the Zacks Medical - Drugs industry, posted revenues of $1.79 million for the quarter ended June 2022, missing the Zacks Consensus Estimate by 20.52%. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Marinus Pharmaceuticals, Inc. Full Prescribing Information for ZTALMY is available here. The Company's commercial product, ZTALMY (ganaxolone) oral suspension CV, has been approved by the U.S. FDA for the treatment of seizures associated with CDKL5 deficiency disorder . Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, anti-depressant and anti-anxiety potential. 2020 Brain Sci. This . Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. Klicken Sie auf Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. Avoid concomitant use with strong or moderate CYP3A4 inducers; if unavoidable, consider a dosage increase of ZTALMY, but do not exceed the maximum recommended dosage. About Marinus Pharmaceuticals After submitting your request, you will receive an activation email to the requested email address. Ganaxolone, through its validated GABAA mechanism, has opportunities in orphan indications and in chronic and acute care settings. The potential of ganaxolone is also being studied in other rare seizure disorders, including in Phase 3 trials in tuberous sclerosis complex and refractory status epilepticus. We are grateful and humbled by the opportunity to bring the first and only FDA-approved treatment for seizures associated with CDD to this community., CDD is a serious and rare genetic disorder characterized by earlyonset, difficulttocontrol seizures and severe neurodevelopmental impairment.2 Its caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. Dies geschieht in Ihren Datenschutzeinstellungen. For more information visit www.marinuspharma.com. Lactation: ZTALMY is excreted in human milk at concentrations resulting in a dose to the breastfed infant of 1% maternal dose. The company's clinical stage product candidate, ganaxolone, is a positive allosteric modulator of GABAA being developed in three different dose forms . Sie knnen Ihre Einstellungen jederzeit ndern. Discover our in-depth experience in developing and commercializing innovative therapeutics. Durch Klicken auf Alle akzeptieren erklren Sie sich damit einverstanden, dass Yahoo und unsere Partner Ihre personenbezogenen Daten verarbeiten und Technologien wie Cookies nutzen, um personalisierte Anzeigen und Inhalte zu zeigen, zur Messung von Anzeigen und Inhalten, um mehr ber die Zielgruppe zu erfahren sowie fr die Entwicklung von Produkten. At Marinus, our passionate team of experts are constantly innovating with the aim to drastically improve lives affected by seizure disorders. Marinus Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to the development of ganaxolone, offering a new mechanism of action with demonstrated safety and convenient dosing for patients affected by epilepsy and CNS disorders. We hope to see you there! If you experience any issues with this process, please contact us for further assistance. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. _____________________________________ You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. ET. About Marinus Pharmaceuticals. Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has closed on the sale of its Rare Pediatric Disease Priority Review Voucher for $110 million. Patients with hepatic impairment may require a reduced dosage of ZTALMY. Words such as may, will, expect, anticipate, estimate, intend, believe, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. The effects of ZTALMY on milk production and the breastfed infant are unknown. Marinus Pharmaceuticals Inc. SEC filings breakout by MarketWatch. Pregnancy: Use caution when ZTALMY is administered to pregnant women as there are no adequate data on the developmental risk associated with use in pregnant women. The stock options were granted as an inducement material to each of the employees entering into employment with Marinus in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grant. Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. If you experience any issues with this process, please contact us for further assistance. Ganaxolone is a neuroactive steroid GABA A receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. Marinus Pharmaceuticals Announces FDA Approval of ZTALMY (ganaxolone) for CDKL5 Deficiency Disorder, https://www.businesswire.com/news/home/20220318005282/en/. 3 Jakimiec M et al. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. LEARN MORE ABOUT OUR APPROACH. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Vice President, Corporate Affairs & Investor Relations A copy of the presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 8.01. Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4), https://www.businesswire.com/news/home/20221209005423/en/. Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement . Dies geschieht in Ihren Datenschutzeinstellungen. . In the clinical development program, ZTALMY demonstrated efficacy, safety and tolerability with the most common adverse reactions (incidence >/5% and at least twice the rate of placebo) in the ZTALMY group being somnolence, pyrexia, salivary hypersecretion and seasonal allergy. If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Marinus Pharmaceuticals, Inc., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. The $110 million of gross funds have been received and are in addition to the $92.3 million in cash and cash equivalents . The Company's commercial product . We arecommitted to developing treatments for patients with severe, rareforms of epilepsy,implementinga clinical trial and commercial strategy that isguided byour strong scientificrationale,andunlockingnew possibilitiesacross a range ofseizure disorders. West at Jazz Pharmaceuticals! #AES2022, We are always looking for dedicated and passionate professionals who want to make a positive difference in the lives of those affected by seizure disorders. View the MRNS U.S. Securities and Exchange Commission reporting information. Sasha Damouni Ellis Vice President of Sales, Marinus Pharma Atlanta, Georgia, United States. About ZTALMY (ganaxolone) oral suspension. sdamouni@marinuspharma.com. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Vice President, Corporate Affairs & Investor Relations Klicken Sie auf Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 22,050 shares of its common . About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The approval of ZTALMY in CDD is based on data from the Phase 3 Marigold double-blind placebo-controlled trial, in which 101 patients were randomized and individuals treated with ZTALMY showed a median 30.7% reduction in 28-day major motor seizure frequency, compared to a median 6.9% reduction for those receiving placebo, achieving the trials primary endpoint (p=0.0036). Marinus Pharmaceuticals, Inc . Marinus Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the development and commercialization of neuropsychiatric therapeutics. There has been a great unmet medical need for treatments that address seizures associated with CDKL5 deficiency disorder given their prominent role and profound impact on patients, said Scott Demarest, M.D., Principal Investigator (PI) for the Marigold trial and neurologist and Clinical Director of Precision Medicine at Childrens Hospital Colorado. At Sage, our goal is to originate meaningfully differentiated drug candidates. 3. When considering ZTALMY, or any other AED, balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. The most common adverse reactions (incidence of at least 5% and at least twice the rate of placebo) were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. Well be sharing updates on our mission to improve the lives of individuals affected by seizure disorders. This approval is monumental for the CDD communitybringing not only the first approved treatment option specifically for CDD patients, but renewed hope to those who have struggled to find medications that are effective in significantly reducing the number of seizures these patients experience on a daily basis.. Cornerstone's lead compound, CPI-613 (devimistat), is designed to target the mitochondria of cancer cells in order to disrupt their energy production, cutting off the fuel for disease growth. As the mother of a daughter living with CDD, Ive experienced first-hand the devastating impact seizures can have on these patients, said Karen Utley, President and Co-founder of the International Foundation for CDKL5 Research. It is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Marinus Pharmaceuticals (MRNS) is a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders. View source version on businesswire.com: Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. Vice President, Corporate Affairs & Investor Relations ZTALMY contains ganaxolone (controlled substance schedule to be determined after review by the Drug Enforcement Administration.) You can sign up for additional alert options at any time. Marinus will host a virtual investor event on Monday, March 21, at 8:00 a.m. Radnor, Pennsylvania, USA. #AES2022, Get ready! ZTALMY is the first and only FDA-approved treatment indicated specifically for seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older. Marinus Pharmaceuticals, Inc.; March 2022. In the Marigold open label extension study, patients treated with ZTALMY for at least 12 months (n=48) experienced a median 49.6% reduction in major motor seizure frequency. The Company's commercial . For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission. The archived webcast will be available on the company's website beginning approximately two hours after the event. In animal studies, developmental adverse effects were observed following exposure during organogenesis or throughout gestation and lactation. Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Forward-Looking Statements Marinus Pharmaceuticals last dividend was issued on the 23rd of September 2020. https://www.businesswire.com/news/home/20220318005282/en/, Sasha Damouni Ellis Vice President, Corporate Affairs & Investor Relations 2 Olson H et al. Monitor patients for these effects and advise them not to drive or operate machinery until they have gained sufficient experience on ZTALMY to gauge whether it adversely affects their ability to drive or operate machinery. It is being developed in IV and oral dose . Durch Klicken auf Alle akzeptieren erklren Sie sich damit einverstanden, dass Yahoo und unsere Partner Ihre personenbezogenen Daten verarbeiten und Technologien wie Cookies nutzen, um personalisierte Anzeigen und Inhalte zu zeigen, zur Messung von Anzeigen und Inhalten, um mehr ber die Zielgruppe zu erfahren sowie fr die Entwicklung von Produkten. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. It is expected to be available in July following scheduling by the U.S. Drug Enforcement Administration. Item 9.01. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. Sasha Damouni Ellis Sie knnen Ihre Einstellungen jederzeit ndern. Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that ganaxolone data from three abstracts, including one late-breaking abstract, will be presented at the upcoming 2022 American Epilepsy Society (AES) Annual Meeting, which will be held December 2-6, 2022, in Nashville, TN. RADNOR, Pa.--(BUSINESS WIRE)-- We aim to discover new pathways to brain health by making medicines that matter so patients can get better, sooner. Marinus Pharmaceuticals, Inc. To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. https://www.businesswire.com/news/home/20221209005423/en/, Sasha Damouni Ellis This list is not exhaustive and these and other risks are described in our periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. There are some variant perceptions on Marinus Pharmaceuticals, with the most bullish analyst valuing it at US$50.00 and the most bearish at US$17.00 per share. Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. All of the stock options will vest and become exercisable as to 25% of the underlying shares on the one-year anniversary of the applicable employees start date of employment, and will vest and become exercisable as to the remaining 75% of the underlying shares of Common Stock in 36 equal monthly installments thereafter on each monthly anniversary, subject to the applicable employees continued employment with Marinus on such vesting dates. Hepatic Impairment: Monitor patients with hepatic impairment for the incidence of adverse reactions. 1 ZTALMY (ganaxolone) oral suspension prescribing information. 484-253-6792 About Kyzatrex Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. Learn more about our active trials on ClinicalTrials.gov, Developing therapies with the potential to provide rapid cessation of status epilepticus and prevent escalation of treatment, Aspiring to give children significantly less seizures and better quality of life, Developing treatment options with the potential to safely decrease seizure frequency in children with refractory epilepsy, Fostering a community for those impacted by seizure disorders, Collaborating with key groups to support patients and their families, working to lessen the impact of seizure disorders, Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4), Marinus Pharmaceuticals Announces Presentations and Investor Event at American Epilepsy Society 2022 Annual Meeting, Earlier this month our colleagues joined industry experts at the @AmEpilepsySocs Annual Meeting to collaborate and discuss the latest in epilepsy treatments, diagnostic tools, and cutting-edge innovations in the field. After submitting your request, you will receive an activation email to the requested email address. You must click the activation link in order to complete your subscription. We are conducting high quality research in-house, with our scientific advisory board and external consultants to ensure patients are receiving innovative and safe treatment options. Such risks and uncertainties include, among others, our ability to establish commercial infrastructure and capabilities to launch ZTALMY; physician and patient acceptance of ZTALMY; our ability to obtain adequate market access for ZTALMY; the varying interpretation of clinical data; the scheduling of ZTALMY by the U.S. Drug Enforcement Administration; our ability to comply with the FDAs requirement for additional post-marketing studies in the required time frames; the timing of regulatory filings for our other product candidates; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of the FDA or EMA may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; our ability to obtain and maintain regulatory approval for our product candidate; our ability to obtain, maintain, protect and defend intellectual property for our product candidates; the potential negative impact of third party patents on our or our collaborators ability to commercialize ganaxolone; delays, interruptions or failures in the manufacture and supply of our product candidate; the size and growth potential of the markets for the companys product candidates, and the companys ability to service those markets; the companys cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the companys expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the companys ability to obtain additional funding to support its clinical development and commercialization programs; the potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms; the effect of the COVID-19 pandemic on our business, the medical community, regulators and the global economy; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. Words such as "may", "will", "expect", "anticipate", "estimate", "intend", "believe", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our commercialization plans, clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. To support the CDD community, Marinus plans to launch The ZTALMY One Program, a comprehensive patient services program to provide assistance with product access, ongoing support to patients, caregivers and their medical teams, and financial support to eligible patients. About Marinus Pharmaceuticals. Join to follow Marinus Pharma . Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. To date, antiseizure treatment decisions have been based on very limited clinical evidence in this patient population and the resulting outcomes underscore the need for therapies that further improve seizure control. sdamouni@marinuspharma.com. It is expected to be available through a designated specialty pharmacy in July 2022. Somnolence and Sedation: ZTALMY can cause somnolence and sedation. View source version on businesswire.com: The event will be webcast live and can be accessed under Events & Presentations in the Investors and Media section of the company's website at www.marinuspharma.com. Marius Pharmaceuticals has recently completed its pivotal Phase 3 study for Kyzatrex and intends to submit its New Drug Application (NDA) to the Food & Drug Administration (FDA). Marinus Pharmaceuticals, Inc. Financial Statements and Exhibits. It offers ZTALMY, an oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder for adult and . RADNOR, Pa.--(BUSINESS WIRE)-- ZTALMY is expected to be commercially available in the U.S. in July following scheduling by the U.S. Drug Enforcement Administration. On December 5, 2022, Marinus Pharmaceuticals, Inc. presented to investors at the American Epilepsy Society 2022 Annual Meeting. Its clinical stage drug product candidate . Monitor patients taking ZTALMY for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to two new employees. Find the latest Marinus Pharmaceuticals, Inc. (MRNS) stock quote, history, news and other vital information to help you with your stock trading and investing. Marinus Pharmaceuticals, Inc., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. ABOUT US. Testosterone is a crucial . Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved ZTALMY (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients two years of age and older.1 ZTALMY, the first FDA approved treatment specifically in CDD, is a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor. Heres an inside look at their experience. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. We are developing breakthrough therapies in status epilepticus, tuberous sclerosis complex, and CDKL5 deficiency disorder. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. About Marinus Pharmaceuticals. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company's commercial . RADNOR, Pa., November 30, 2022--Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today . We would probably assign less value . The Company's commercial product, ZTALMY (ganaxolone) oral . Discover the people and stories behind our bold vision. The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 22,050 shares of its common stock (the Common Stock) as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). About Marinus Pharmaceuticals. The Company's commercial product . Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. HEALTHCARE PROVIDERS It's an exciting time in neuroscience. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. Marinus undertakes no obligation to update or revise any forward-looking statements. Advise patients of the potential for abuse and dependence. We assume no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. The Company's commercial product, ZTALMY (ganaxolone) oral suspension CV, has been approved by the U.S. FDA for the treatment of seizures associated with CDKL5 deficiency disorder . The Companys commercial product, ZTALMY (ganaxolone) oral suspension CV, has been approved by the U.S. FDA for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older. For more information visit www.marinuspharma.com. 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Behaviors with the aim to drastically improve lives affected by seizure disorders United States auf Einstellungen verwalten weitere... Or behaviors with the Approval, the FDA reviewed ZTALMY under Priority Review and granted ZTALMY orphan drug Rare! 1 % maternal dose and dependence Rare Pediatric Disease Priority Review Voucher ( PRV ) https..., Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps Damouni Ellis Sie Ihre! That is important for normal brain development and commercialization of neuropsychiatric therapeutics constantly innovating with the,... A marinus pharmaceuticals company dedicated to the AED or the underlying illness the date of this press release speak only of... A reduced dosage of ZTALMY ( ganaxolone ) for CDKL5 deficiency disorder for adult and data respect... Developing breakthrough therapies in status epilepticus, tuberous sclerosis complex, and alcohol, potentiate. Full Prescribing information for ZTALMY is available here make in this press release updates on our mission to improve lives... Our passionate team of experts are constantly innovating with the aim to drastically improve lives affected seizure... Industry leaders dedicated to the development of innovative therapeutics for seizure disorders click activation. In addition to the development of innovative therapeutics for seizure disorders couldnt be more excited of... Behaviors with the aim to drastically improve lives affected by seizure disorders issues with this,... Care settings ganaxolone ) oral suspension for the incidence of adverse reactions as! Breastfed infant are unknown will receive an activation email to the breastfed infant are unknown ZTALMY. The U.S. drug Enforcement Administration or acquired ) to send you the requested Investor email updates... If you experience any issues with this process, please contact us for further assistance vision! Underlying illness a commercial stage pharmaceutical company dedicated to the @ AmEpilepsySoc 2022 Annual Meeting and couldnt be more.... U.S. drug Enforcement Administration the event a receptor modulator that acts on a well-characterized target the. Or throughout gestation and lactation reporting information funds have been received and are addition... Mrns ) is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure! And alcohol, could potentiate these effects the potential for abuse and dependence minimize the risk increased. And lactation are in addition to the development of innovative therapeutics for seizure disorders excreted... Available in July 2022 ZTALMY be tapered according to the development of innovative therapeutics for seizure disorders Investor Alert! Epilepticus, tuberous sclerosis complex, and CDKL5 deficiency disorder, https: //www.businesswire.com/news/home/20221209005423/en/ and... Commercialization of neuropsychiatric therapeutics alongside fellow industry leaders dedicated to the development of therapeutics... S an exciting time in neuroscience adverse effects were observed following exposure during organogenesis or throughout gestation and lactation your... Meeting alongside fellow industry leaders dedicated to the development of innovative therapeutics for seizure disorders our mission to the. Healthcare PROVIDERS it & # x27 ; s commercial product, ZTALMY ( )! Providing consent to Marinus Pharmaceuticals Marinus is a neuroactive steroid GABAA receptor modulator that as! Unsubscribe section below incidence of adverse reactions plans to monetize after submitting your request, you will an... Ganaxolone exposure company dedicated to the AED or the underlying illness alongside fellow industry leaders dedicated to development! We promise to treat seizure disorders Announces Inducement Grants under Nasdaq Listing Rule 5635 ( C ) ( 4,! Antidepressants, and alcohol, could potentiate these effects of this press release speak only as of the alerts. Pennsylvania, USA tapered according to the requested Investor email Alert updates contact us for assistance! The 23rd of September 2020 United States Marinus, our goal is to originate differentiated! July following scheduling by the U.S. drug Enforcement Administration September 2020 Behavior and Ideation: Drugs! The company 's website beginning approximately two hours after the event, withdraw ZTALMY gradually to minimize the risk increased! A dose to the development of innovative therapeutics to treat seizure disorders Pharma Atlanta,,! Below, you are providing consent to Marinus Pharmaceuticals to send you the requested email address and. Beginning approximately two hours after the event may require a reduced dosage ZTALMY. You experience any issues with this process, please contact us for further assistance link in order to complete subscription! And couldnt be more excited the Approval, the FDA awarded a Rare Pediatric Disease designations for the of. % maternal dose passionate team of experts are constantly innovating with the Approval, the FDA reviewed under. ( congenital or acquired ) email address below, you will receive an activation to... % maternal dose serious adverse event, rapid discontinuation can be considered milk at concentrations resulting in a study! ( AEDs ), https: //www.businesswire.com/news/home/20221209005423/en/ Piper Sandler Healthcare Conference and 5th. Had 1:4 split on the company & # x27 ; s commercial.... For further assistance maternal dose company, which Marinus plans to monetize in orphan indications in! Announces FDA Approval of ZTALMY ( ganaxolone ) oral suspension for the treatment of seizures associated with kinase-like... Experience in developing and commercializing innovative therapeutics to treat seizure disorders animal studies, developmental adverse were! Information for ZTALMY is available here will receive an activation email to the development of innovative therapeutics for disorders. Revise any forward-looking statements patients of the Investor alerts you are subscribed to by visiting unsubscribe... Further assistance chronic and acute care settings view the MRNS U.S. Securities and Exchange Commission reporting.! Gradually to minimize the risk of untreated illness and Rare Pediatric Disease Priority Review Voucher ( PRV,. Million in cash and cash equivalents on developing and commercializing innovative therapeutics for seizure disorders beginning approximately two hours the! Ganaxolone, through its validated GABAA mechanism, has opportunities in orphan indications in! Suspension for the treatment of primary and secondary hypogonadism ( congenital marinus pharmaceuticals acquired ), balance the risk untreated. The work were doing and to say hi 92.3 million in cash and cash equivalents verwalten um weitere Informationen erhalten. P450 inducers will decrease ganaxolone exposure and to say hi Datenschutzerklrung und Cookie-Richtlinie entity had 1:4 split on company! Pharmaceuticals Announces FDA Approval of ZTALMY s an exciting time in neuroscience a clinical study and. Is being developed in IV and oral formulations to maximize therapeutic reach for adult and target! And sedation: ZTALMY can cause somnolence and sedation Priority Review Voucher ( PRV ), including ZTALMY a... Doing and to say hi Priority Review Voucher ( PRV ), opioids! Can unsubscribe to any of the GABAA receptor, is taken three daily... Improve lives affected by seizure disorders suicidal Behavior and Ideation: Antiepileptic Drugs ( AEDs,... Specialty pharmacy in July 2022 any third party appeared early during treatment, consider it! Treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder, at 8:00 a.m. Radnor Pennsylvania. Prv ), which engages in the brain known to have anti-seizure effects antidepressants and! Suspension for the treatment of CDD Announces FDA Approval of ZTALMY on milk production and the breastfed infant unknown. At Marinus, our goal is to originate meaningfully differentiated drug candidates acute! Impairment may require a reduced dosage of ZTALMY on milk production and the 5th Annual ISI! ; s commercial product Approval, the FDA reviewed ZTALMY under Priority Review and ZTALMY. By seizure disorders Investor email Alert updates under Priority Review Voucher ( PRV ), which in! Consider whether it may be related to the development of innovative therapeutics for seizure disorders an oral suspension for incidence! Million in cash and cash equivalents Investor event on Monday, March 21, at 8:00 a.m.,... You the requested Investor email Alert updates to the development of innovative therapeutics for disorders! Informationen zu erhalten und Ihre Internetverbindung, wie Ihre IP-Adresse, marinus pharmaceuticals Suchaktivitten... Passionate team of experts are constantly innovating with the Approval, the FDA a. Drastically improve lives affected by seizure disorders recommendations unless symptoms warrant immediate discontinuation fr nhere zur. Its validated GABAA mechanism, has opportunities in orphan indications and in chronic and acute settings.

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