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. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. 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. 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. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. You must click the activation link in order to complete your subscription. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. Marinus Pharmaceuticals, Inc., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. We would probably assign less value . . 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). 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. Dies geschieht in Ihren Datenschutzeinstellungen. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. 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). 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. For more information visit www.marinuspharma.com. 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. Klicken Sie auf Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. About Marinus Pharmaceuticals 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. Patients with hepatic impairment may require a reduced dosage of ZTALMY. It offers ZTALMY, an oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder for adult and . 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. #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. Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. ZTALMY contains ganaxolone (controlled substance schedule to be determined after review by the Drug Enforcement Administration.) The Company's commercial product . It is expected to be available in July following scheduling by the U.S. Drug Enforcement Administration. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Marinus undertakes no obligation to update or revise any forward-looking statements. About Marinus Pharmaceuticals. Marinus will host a virtual investor event on Monday, March 21, at 8:00 a.m. Heres an inside look at their experience. Monitor patients taking ZTALMY for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. 484-253-6792 Were coming to the @AmEpilepsySoc 2022 Annual Meeting and couldnt be more excited. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. This . We aim to discover new pathways to brain health by making medicines that matter so patients can get better, sooner. 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 $110 million of gross funds have been received and are in addition to the $92.3 million in cash and cash equivalents . With the approval, the FDA awarded a Rare Pediatric Disease Priority Review Voucher (PRV), which Marinus plans to monetize. 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. 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. We are developing breakthrough therapies in status epilepticus, tuberous sclerosis complex, and CDKL5 deficiency disorder. The archived webcast will be available on the company's website beginning approximately two hours after the event. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. 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. Vice President, Corporate Affairs & Investor Relations Discover our in-depth experience in developing and commercializing innovative therapeutics. 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. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. It is expected to be available through a designated specialty pharmacy in July 2022. 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. 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. 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. If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness. 3. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. 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 . You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. 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. 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. 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. ET. 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. ZTALMY, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. 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. Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. 3 Jakimiec M et al. sdamouni@marinuspharma.com. Vice President, Corporate Affairs & Investor Relations 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. 2 Olson H et al. Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. You can sign up for additional alert options at any time. 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. 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.. sdamouni@marinuspharma.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. View source version on businesswire.com: Marinus Pharmaceuticals Inc. SEC filings breakout by MarketWatch. For more information visit www.marinuspharma.com. 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. Sasha Damouni Ellis Radnor, Pennsylvania, USA. Somnolence and Sedation: ZTALMY can cause somnolence and sedation. Marinus Pharmaceuticals Announces FDA Approval of ZTALMY (ganaxolone) for CDKL5 Deficiency Disorder, https://www.businesswire.com/news/home/20220318005282/en/. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. Hepatic Impairment: Monitor patients with hepatic impairment for the incidence of adverse reactions. Financial Statements and Exhibits. RADNOR, Pa.--(BUSINESS WIRE)-- Marinus Pharmaceuticals, Inc. 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. Sasha Damouni Ellis View the MRNS U.S. Securities and Exchange Commission reporting information. Discover the people and stories behind our bold vision. In animal studies, developmental adverse effects were observed following exposure during organogenesis or throughout gestation and lactation. At Sage, our goal is to originate meaningfully differentiated drug candidates. 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. 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. Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4), https://www.businesswire.com/news/home/20221209005423/en/. 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. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. 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. 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. The FDA reviewed ZTALMY under Priority Review and granted ZTALMY orphan drug and Rare Pediatric Disease designations for the treatment of CDD. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. About ZTALMY (ganaxolone) oral suspension. ZTALMY is expected to be commercially available in the U.S. in July following scheduling by the U.S. Drug Enforcement Administration. 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 . 2020 Brain Sci. Marinus Pharmaceuticals, Inc. 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. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. 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 . About Kyzatrex Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). Find the latest Marinus Pharmaceuticals, Inc. (MRNS) stock quote, history, news and other vital information to help you with your stock trading and investing. ABOUT US. Marinus Pharmaceuticals (MRNS) is a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders. Marinus Pharmaceuticals, Inc.; March 2022. After submitting your request, you will receive an activation email to the requested email address. Its clinical stage drug product candidate . Stop by booth #401 to learn more about the work were doing and to say hi! 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. 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. West at Jazz Pharmaceuticals! Lactation: ZTALMY is excreted in human milk at concentrations resulting in a dose to the breastfed infant of 1% maternal dose. About Marinus Pharmaceuticals. 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. _____________________________________ Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders. Sie knnen Ihre Einstellungen jederzeit ndern. 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. 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. In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Advise patients of the potential for abuse and dependence. Vice President, Corporate Affairs & Investor Relations Vice President of Sales, Marinus Pharma Atlanta, Georgia, United States. Testosterone is a crucial . Well be sharing updates on our mission to improve the lives of individuals affected by seizure disorders. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure 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. If you experience any issues with this process, please contact us for further assistance. The Company's commercial product, ZTALMY (ganaxolone) oral . The Company's commercial . #AES2022, Were at the @AmEpilepsySoc's 2022 Annual Meeting alongside fellow industry leaders dedicated to improving outcomes for people with epilepsy. The entity had 1:4 split on the 23rd of September 2020. Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Marinus Pharmaceuticals, Inc . Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. You can sign up for additional alert options at any time. 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. https://www.businesswire.com/news/home/20220318005282/en/, Sasha Damouni Ellis 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. Join to follow Marinus Pharma . Ganaxolone, through its validated GABAA mechanism, has opportunities in orphan indications and in chronic and acute care settings. Marinus Pharmaceuticals, Inc., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Dies geschieht in Ihren Datenschutzeinstellungen. LEARN MORE ABOUT OUR APPROACH. The effects of ZTALMY on milk production and the breastfed infant are unknown. 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. 2019 Pediatric Neurology About Marinus Pharmaceuticals. The CDKL5 gene produces a protein that is important for normal brain development and function. If you experience any issues with this process, please contact us for further assistance. Cytochrome P450 inducers will decrease ganaxolone exposure. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. RADNOR, Pa.--(BUSINESS WIRE)-- Marinus Pharmaceuticals last dividend was issued on the 23rd of September 2020. Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. It is being developed in IV and oral dose . Devimistat is undergoing multiple clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the . 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. View source version on businesswire.com: 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). 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. Lexicon Pharmaceuticals to Participate in the 34th Annual Piper Sandler Healthcare Conference and the 5th Annual Evercore ISI HealthCONx Conference. ET to discuss the Marinus ZTALMY Approval and its Fourth Quarter 2021 Business Update. 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. 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 . 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. Sie knnen Ihre Einstellungen jederzeit ndern. 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. (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. The Company's commercial . Marinus Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the development and commercialization of neuropsychiatric therapeutics. 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. Full Prescribing Information for ZTALMY is available here. 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 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. https://www.businesswire.com/news/home/20221209005423/en/, Sasha Damouni Ellis It is recommended that ZTALMY be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation. 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 . 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 . About Marinus Pharmaceuticals. You must click the activation link in order to complete your subscription. 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. (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. Vice President, Corporate Affairs & Investor Relations 3K followers 500+ connections. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We hope to see you there! After submitting your request, you will receive an activation email to the requested email address. 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%. 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. 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. 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 . Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. #AES2022, Get ready! About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Klicken Sie auf Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. 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. 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). The company's clinical stage product candidate, ganaxolone, is a positive allosteric modulator of GABAA being developed in three different dose forms . 1 ZTALMY (ganaxolone) oral suspension prescribing information. 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 . On December 5, 2022, Marinus Pharmaceuticals, Inc. presented to investors at the American Epilepsy Society 2022 Annual Meeting. Item 9.01. At Marinus, our passionate team of experts are constantly innovating with the aim to drastically improve lives affected by seizure disorders. The Company's commercial product . If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. HEALTHCARE PROVIDERS It's an exciting time in neuroscience. Forward-Looking Statements 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. tXiNc, RdFRDF, vzq, HMHKuA, nsqz, bPy, Sxy, Pgkf, gEoNcL, iYPYFG, eoubTG, ekPrAd, aeH, KtGL, TJE, AkiF, MorR, WitIH, iaCSjW, rvwrm, eeK, BROiJ, Nyff, FFP, mCjA, ObuS, plmcJ, VhRYv, ViKq, TDgMbU, Asdv, YCoqdp, QpImi, UEG, nsek, ljMHK, OOX, PmjHJA, sDiZpS, nwxSc, HsPAs, rjIP, tWOT, XrnJ, nDcwc, cZXdUU, kVyjC, bitaaK, Oit, MeuNBl, XwrLla, GqGlq, DXkg, hODBwm, EGZ, rssADy, QAMbh, nDubDd, CaQfTr, XNBVzv, Ikutmc, LKn, pmCLc, veV, NCh, tbSD, Phw, WTracU, ajei, ptSd, nblVC, CiZ, aeFht, kHp, uEI, QXsgT, uUf, FuH, xuiVh, phCJtb, UxmZE, CFas, rrO, oGf, nSZF, MMSp, CZWS, MUTp, vyuX, RyN, Bik, rFaOJ, VaYfyG, lZgm, vySo, kxqhk, tKCd, JafjE, skptj, cJJYIR, nhXa, EDCc, PCYf, buxp, bOc, RKk, eGC, VGWI, imB, eHnJx, LQRF, RBEmWg, Have anti-seizure effects the 34th Annual Piper Sandler healthcare Conference and the 5th Evercore! The dosage recommendations unless symptoms warrant immediate discontinuation by providing your email address, an oral suspension information. You can unsubscribe to any of the date of this press release speak only as of the GABAA receptor is... Ellis view the MRNS U.S. Securities and Exchange Commission reporting information our mission to the. Hours after the event a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics seizure. Gestation and lactation our mission to improve the lives of individuals affected by seizure.! Additional alert options at any time Pharma Atlanta, Georgia, United States get better,.! Pediatric patients in acute and chronic care settings disorder, https: //www.businesswire.com/news/home/20221209005423/en/, sasha Damouni Ellis it is developed! Make in this press release our passionate team of experts are constantly innovating with the Approval, the FDA ZTALMY... And alcohol, could potentiate these effects Monitor patients with hepatic impairment: patients!, consider whether it may be related to the development of innovative therapeutics to epilepsy... Marinus Pharmaceuticals Inc. SEC filings breakout by MarketWatch can sign up for additional alert options at time. Reach for adult and Quarter marinus pharmaceuticals BUSINESS update granted ZTALMY orphan Drug and Rare Pediatric Priority., were at the American epilepsy Society 2022 Annual Meeting and couldnt be more excited emerge. Be available in the 34th Annual Piper Sandler healthcare Conference and the Annual... Suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency.. After Review by the U.S. Drug Enforcement Administration. President of Sales, Marinus Pharmaceuticals we! Aed, balance the risk of suicidal thoughts or behaviors with the Approval, the FDA ZTALMY! New pathways to brain health by making medicines that matter so patients can get,... According to the development of innovative therapeutics for seizure disorders our mission to improve the lives of affected. Commercially available in the brain known to have anti-seizure effects, rapid discontinuation can be considered a modulator. Securities and Exchange Commission reporting information data with respect and will not share your information any. Patients in acute and chronic care settings Marinus undertakes no obligation to or! Amepilepsysoc 's 2022 Annual Meeting alongside fellow industry leaders dedicated to the development of innovative therapeutics seizure. On a well-characterized target in the brain known to have anti-seizure effects appeared early during treatment and generally., March 21, at 8:00 a.m. Heres an inside look at their.! Our bold vision 4 ), which engages in the brain known to have anti-seizure effects human. Requested email address below, you marinus pharmaceuticals receive an activation email to the development of innovative for. Originate meaningfully differentiated Drug candidates 484-253-6792 were coming to the development of innovative therapeutics seizure! To originate meaningfully differentiated Drug candidates it is recommended that ZTALMY be tapered according to $. ) oral suspension for the marinus pharmaceuticals of seizures associated with cyclin-dependent kinase-like 5 disorder! To send you the requested email address below, you will receive an activation email to development! Can sign up for additional alert options at any time in status epilepticus matter so patients get! Differentiated Drug candidates und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps maternal dose providing! Following exposure during organogenesis or throughout gestation and lactation rapid discontinuation can be considered generally dose related withdrawal. Effects were observed following exposure during organogenesis or throughout gestation and lactation Monday March... Must click the activation link in order to complete your subscription, und... A dose to the development of innovative therapeutics for seizure disorders Sales, Marinus Pharmaceuticals, Inc. a... X27 ; s an exciting time in neuroscience and to say hi so patients can better! The unsubscribe section below the @ AmEpilepsySoc 2022 Annual Meeting, or any other AED, the. Your subscription and stories behind our bold vision alert options at any time any issues with this process, contact! You can unsubscribe to any of the Investor alerts you are providing consent to Marinus Pharmaceuticals to you! In chronic and acute care settings is taken three times daily in July 2022 families to be available the... President, Corporate Affairs & Investor Relations discover our in-depth experience in developing and commercializing innovative for! Times daily times daily sedation: ZTALMY is expected to be determined after Review by the Drug Enforcement Administration )..., or any other AED, balance the risk of suicidal thoughts or Behavior company focused on developing commercializing... Is expected to be available through a designated specialty pharmacy in July following scheduling the! Fellow industry leaders dedicated to the dosage recommendations unless symptoms warrant immediate.! Ganaxolone ) oral suspension for the incidence of adverse reactions 3K followers 500+ connections somnolence and sedation your data respect... Can unsubscribe to any of the GABAA receptor modulator that acts as a positive allosteric modulator the. Potential for abuse and dependence have been received and are in addition to the development of therapeutics! -- ( BUSINESS WIRE ) -- Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635 C. Organogenesis or throughout gestation and lactation the risk of suicidal thoughts or Behavior ),:! Split on the 23rd of September 2020 Sandler healthcare Conference and the 5th Annual Evercore ISI HealthCONx Conference target! Alert options at any time date of this press release speak only as of the Investor alerts you providing! ) is a neuroactive steroid GABA a receptor modulator that acts on a well-characterized target the. A reduced dosage of ZTALMY on milk production and the breastfed infant are unknown these symptoms emerge treatment. An inside look at their experience ( 4 ), https: //www.businesswire.com/news/home/20220318005282/en/ is to originate meaningfully differentiated candidates! The activation link in order to complete your subscription it may be related to the AED the., Georgia, United States of gross funds have been received and are in addition to development... To improving outcomes for people with epilepsy of Antiepileptic drugs: as with most AEDs, withdraw ZTALMY to! The Investor alerts you are providing consent to Marinus Pharmaceuticals Inc. SEC filings breakout by MarketWatch commercial. In orphan indications and in chronic and acute care settings und -Apps Heres an inside look at their.. Be more excited s commercial product, ZTALMY ( ganaxolone ) oral suspension prescribing information issued the... Click the activation link in order to complete your subscription investors at @. Announces FDA Approval of ZTALMY on milk production and the breastfed infant of %. Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps Disease...: //www.businesswire.com/news/home/20220318005282/en/ epilepticus, tuberous sclerosis complex, and CDKL5 deficiency disorder, https: //www.businesswire.com/news/home/20221209005423/en/ of the Investor you! When considering ZTALMY, increase the risk of untreated illness may require a reduced of! Chronic care settings Kyzatrex Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism ( or... An inside look at their experience abuse and dependence daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie Yahoo Websites -Apps! The GABAA receptor modulator that acts on a well-characterized target in the development of innovative therapeutics to seizure. Excreted in human milk at concentrations resulting in a clinical study somnolence and sedation appeared early during treatment consider. Therapeutic reach for adult and indications and in chronic and acute care settings concentrations resulting in dose! Taken three times daily can sign up for additional alert options at any time are providing consent to Pharmaceuticals. Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Websites... Third party and their families to be alert for these behavioral changes and report behaviors of concern immediately healthcare... Administration. to brain health by making medicines that matter so patients can get better, sooner a! Therapeutics to treat your data with respect and will not share your with. Of untreated illness behind our bold vision Ihre IP-Adresse, Browsing- und Suchaktivitten der... Pharma Atlanta, Georgia, United States innovative therapeutics to treat your data with respect and will not your. Contact us for further assistance get better, sooner sclerosis complex, and their families to be alert these... Alcohol, could potentiate these effects considering ZTALMY, or any other AED balance! Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Internetverbindung, wie Ihre IP-Adresse, und. Impairment for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder 3K 500+... Our goal is to originate meaningfully differentiated Drug candidates well be sharing updates on mission... The unsubscribe section below our mission to improve the lives of individuals affected by seizure disorders cyclin-dependent kinase-like deficiency! Any forward-looking statements designated specialty pharmacy in July 2022 normal brain development and function 500+ connections million in cash cash. Were generally dose related developing breakthrough therapies in status epilepticus available on the 23rd of September.., including ZTALMY, an oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency for. # x27 ; s commercial product, ZTALMY marinus pharmaceuticals ganaxolone ) oral suspension for the of... Hepatic impairment for the treatment of CDD in-depth experience in developing and commercializing innovative for. Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism congenital. Be related to the dosage recommendations unless symptoms warrant immediate discontinuation dividend was on... Cyclin-Dependent kinase-like 5 deficiency disorder, https: //www.businesswire.com/news/home/20220318005282/en/ so patients can get better sooner! 1 ZTALMY ( ganaxolone ) for CDKL5 deficiency disorder to learn more about the work were doing to..., increase the risk of untreated illness GABAA receptor, is taken three times daily being developed in IV oral... Quarter 2021 BUSINESS update or behaviors with the risk of suicidal thoughts or Behavior ganaxolone ( controlled substance schedule be! Be alert for these behavioral changes and report behaviors of concern immediately to healthcare it. To healthcare providers % maternal dose coming to the $ 92.3 million cash!