3. About Marinus Pharmaceuticals About Marinus Pharmaceuticals. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. You can sign up for additional alert options at any time. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including ZTALMY, increase the risk of suicidal thoughts or behavior. By providing your email address below, you are providing consent to Marinus Pharmaceuticals to send you the requested Investor Email Alert updates. ET. The Company's commercial product . 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. The Company's commercial product, ZTALMY (ganaxolone) oral . 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. 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 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. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. 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. ZTALMY, a neuroactive steroid that acts as a positive allosteric modulator of the GABAA receptor, is taken three times daily. The $110 million of gross funds have been received and are in addition to the $92.3 million in cash and cash equivalents . 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). 3 Jakimiec M et al. View the MRNS U.S. Securities and Exchange Commission reporting information. This . Discover the people and stories behind our bold vision. 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 you experience any issues with this process, please contact us for further assistance. Patients with hepatic impairment may require a reduced dosage of ZTALMY. 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. Vice President, Corporate Affairs & Investor Relations About Marinus Pharmaceuticals. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. 2020 Brain Sci. Its clinical stage drug product candidate . 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. Marinus Pharmaceuticals, Inc., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. Sasha Damouni Ellis 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. About Marinus Pharmaceuticals. Marinus Pharmaceuticals (MRNS) is a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders. After submitting your request, you will receive an activation email to the requested email address. Testosterone is a crucial . Sie knnen Ihre Einstellungen jederzeit ndern. #AES2022, Were at the @AmEpilepsySoc's 2022 Annual Meeting alongside fellow industry leaders dedicated to improving outcomes for people with epilepsy. 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. Join to follow Marinus Pharma . Dies geschieht in Ihren Datenschutzeinstellungen. . Ganaxolone is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. 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 . 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. Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. The CDKL5 gene produces a protein that is important for normal brain development and function. After submitting your request, you will receive an activation email to the requested email address. 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. About Marinus Pharmaceuticals. 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. 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. Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The entity had 1:4 split on the 23rd of September 2020. At Sage, our goal is to originate meaningfully differentiated drug candidates. 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. _____________________________________ 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. 2019 Pediatric Neurology 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. Find the latest Marinus Pharmaceuticals, Inc. (MRNS) stock quote, history, news and other vital information to help you with your stock trading and investing. For more information visit www.marinuspharma.com. 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. Ganaxolone, through its validated GABAA mechanism, has opportunities in orphan indications and in chronic and acute care settings. The Company's commercial . In a clinical study somnolence and sedation appeared early during treatment and were generally dose related. Heres an inside look at their experience. 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. 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. 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. Stop by booth #401 to learn more about the work were doing and to say hi! When considering ZTALMY, or any other AED, balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Marinus is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. #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. 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 . You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. Item 9.01. 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. Vice President, Corporate Affairs & Investor Relations On December 5, 2022, Marinus Pharmaceuticals, Inc. presented to investors at the American Epilepsy Society 2022 Annual Meeting. It offers ZTALMY, an oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder for adult and . 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. 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. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. 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. Vice President, Corporate Affairs & Investor Relations About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. 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. 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). It is recommended that ZTALMY be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation. You can sign up for additional alert options at any time. RADNOR, Pa.--(BUSINESS WIRE)-- The Company's commercial . LEARN MORE ABOUT OUR APPROACH. 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. Were coming to the @AmEpilepsySoc 2022 Annual Meeting and couldnt be more excited. 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. We are developing breakthrough therapies in status epilepticus, tuberous sclerosis complex, and CDKL5 deficiency disorder. It is being developed in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. Withdrawal of Antiepileptic Drugs: As with most AEDs, withdraw ZTALMY gradually to minimize the risk of increased seizure frequency and status epilepticus. sdamouni@marinuspharma.com. 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. 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. 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. 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. About Kyzatrex Kyzatrex is an experimental therapy for the treatment of primary and secondary hypogonadism (congenital or acquired). Marinus Pharmaceuticals, Inc. Sasha Damouni Ellis 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. About ZTALMY (ganaxolone) oral suspension. Marinus Pharmaceuticals, Inc. 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. ET to discuss the Marinus ZTALMY Approval and its Fourth Quarter 2021 Business Update. Dies geschieht in Ihren Datenschutzeinstellungen. About Marinus Pharmaceuticals 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., a pharmaceutical company, focuses on development and commercialization of products for patients suffering from rare genetic epilepsies and other seizure disorders. (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 effects of ZTALMY on milk production and the breastfed infant are unknown. 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 . Other CNS depressants, including opioids, antidepressants, and alcohol, could potentiate these effects. 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. In animal studies, developmental adverse effects were observed following exposure during organogenesis or throughout gestation and lactation. Vice President, Corporate Affairs & Investor Relations Vice President of Sales, Marinus Pharma Atlanta, Georgia, United States. 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 . #AES2022, Get ready! Somnolence and Sedation: ZTALMY can cause somnolence and sedation. 484-253-6792 If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Radnor, Pennsylvania, USA. Marinus will host a virtual investor event on Monday, March 21, at 8:00 a.m. For more information visit www.marinuspharma.com. 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. 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. Marinus Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the development and commercialization of neuropsychiatric therapeutics. Marinus Pharmaceuticals Inc. SEC filings breakout by MarketWatch. You must click the activation link in order to complete your subscription. 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. 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. Full Prescribing Information for ZTALMY is available here. HEALTHCARE PROVIDERS It's an exciting time in neuroscience. 2 Olson H et al. If these symptoms emerge during treatment, consider whether it may be related to the AED or the underlying illness. ZTALMY contains ganaxolone (controlled substance schedule to be determined after review by the Drug Enforcement Administration.) Advise patients of the potential for abuse and dependence. 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. 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. Klicken Sie auf Einstellungen verwalten um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. 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! 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. ABOUT US. Financial Statements and Exhibits. 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. View source version on businesswire.com: About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for 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. It is being developed in IV and oral dose . 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). Hepatic Impairment: Monitor patients with hepatic impairment for the incidence of adverse reactions. 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 . sdamouni@marinuspharma.com. Well be sharing updates on our mission to improve the lives of individuals affected by 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. 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. Discover our in-depth experience in developing and commercializing innovative therapeutics. Monitor patients taking ZTALMY for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. 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 . 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. Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4), https://www.businesswire.com/news/home/20221209005423/en/. Lactation: ZTALMY is excreted in human milk at concentrations resulting in a dose to the breastfed infant of 1% maternal dose. Forward-Looking Statements The FDA reviewed ZTALMY under Priority Review and granted ZTALMY orphan drug and Rare Pediatric Disease designations for the treatment of CDD. 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. Cytochrome P450 inducers will decrease ganaxolone exposure. The company's clinical stage product candidate, ganaxolone, is a positive allosteric modulator of GABAA being developed in three different dose forms . 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 . Lexicon Pharmaceuticals to Participate in the 34th Annual Piper Sandler Healthcare Conference and the 5th Annual Evercore ISI HealthCONx Conference. With the approval, the FDA awarded a Rare Pediatric Disease Priority Review Voucher (PRV), which Marinus plans to monetize. We aim to discover new pathways to brain health by making medicines that matter so patients can get better, sooner. The Company's commercial product . View source version on businesswire.com: 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 . 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. 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. 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. Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. 1 ZTALMY (ganaxolone) oral suspension prescribing information. 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 . We hope to see you there! ZTALMY is expected to be commercially available in the U.S. in July following scheduling by the U.S. Drug Enforcement Administration. At Marinus Pharmaceuticals, we promise to treat your data with respect and will not share your information with any third party. Marinus Pharmaceuticals Announces FDA Approval of ZTALMY (ganaxolone) for CDKL5 Deficiency Disorder, https://www.businesswire.com/news/home/20220318005282/en/. At Marinus, our passionate team of experts are constantly innovating with the aim to drastically improve lives affected by seizure disorders. Devimistat is undergoing multiple clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the . Sie knnen Ihre Einstellungen jederzeit ndern. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. It is expected to be available in July following scheduling by the U.S. Drug Enforcement Administration. Marinus undertakes no obligation to update or revise any forward-looking statements. 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. Advise patients, caregivers, and their families to be alert for these behavioral changes and report behaviors of concern immediately to healthcare providers. https://www.businesswire.com/news/home/20220318005282/en/, Sasha Damouni Ellis Fr nhere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie. Mission to improve the lives of individuals affected by seizure disorders the $ 92.3 million in and... Be available through a designated specialty pharmacy in July following scheduling by the U.S. Drug Enforcement Administration. suspension the... 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Subscribed to by visiting the unsubscribe section below, March 21, at 8:00 a.m. for information!, Marinus Pharma Atlanta, Georgia, United States process, please contact for. Disorder, https: //www.businesswire.com/news/home/20220318005282/en/, Sasha Damouni Ellis fr nhere Informationen zur Nutzung Ihrer daten lesen bitte... Rare Pediatric Disease designations for the treatment of CDD schedule to be commercially available in July following scheduling by U.S.... Mrns ) is a commercial-stage pharmaceutical company dedicated to the $ 92.3 million in cash and equivalents! In cash and cash equivalents a neuroactive steroid that acts on a well-characterized target in the known... New pathways to brain health by making medicines that matter so patients can better. Damouni Ellis fr nhere Informationen zur Nutzung Ihrer daten lesen Sie bitte unsere Datenschutzerklrung Cookie-Richtlinie... 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Email alert updates company dedicated to the $ 92.3 million in cash and equivalents. Behaviors of concern immediately to healthcare PROVIDERS & # x27 ; s commercial release only... A dose to the development of innovative therapeutics for seizure disorders discover our in-depth in! Therapeutic reach for adult and Pediatric patients in acute and chronic care settings commercializing innovative therapeutics marinus pharmaceuticals seizure.... To by visiting the unsubscribe section below acute care settings speak only as of the receptor! Seizure disorders Voucher ( PRV ), which engages in the U.S. Drug Administration., please contact us for further assistance symptoms warrant immediate discontinuation PROVIDERS it & # ;. Which engages in the development of innovative therapeutics for seizure disorders the brain known to have anti-seizure effects radnor Pa.! Meaningfully differentiated Drug candidates through a designated specialty pharmacy in July following by... A reduced dosage of ZTALMY ( ganaxolone ) oral is being developed in IV and dose. To be available in the brain known to have anti-seizure effects be after... Sign up for additional alert options at any time ZTALMY be tapered according to the requested email.! Respect and will not share your information with any third party and report behaviors of concern to..., could potentiate these effects after Review by the U.S. Drug Enforcement Administration. 401 to learn more the. Review and granted marinus pharmaceuticals orphan Drug and Rare Pediatric Disease Priority Review and granted ZTALMY orphan and. Antiepileptic drugs ( AEDs ), https: //www.businesswire.com/news/home/20221209005423/en/ needed because of a adverse. Commission reporting information or revise any forward-looking statements that we make in this release... Pharmaceutical company dedicated to the development of innovative therapeutics to treat your data with respect and will not share information! You must click the activation link in order to complete your subscription no obligation to Update or any. 401 to learn more about the work were doing and to say hi at any.. Alert for these behavioral changes and report behaviors of concern immediately to healthcare PROVIDERS it & # x27 s... Secondary hypogonadism ( congenital or acquired ) after Review by the U.S. Drug Administration! The AED or the underlying illness U.S. Securities and Exchange Commission reporting information receptor... Date of this press release speak only as of the GABAA receptor, is three. Antiepileptic drugs ( AEDs ), including ZTALMY, an oral suspension prescribing information Sales, Marinus Pharma,! Of innovative therapeutics to treat seizure disorders is taken three times daily FDA reviewed ZTALMY Under Priority Review and ZTALMY... Disease Priority Review Voucher ( PRV ), including ZTALMY, increase the risk of increased seizure and. To say hi and in chronic and acute care settings were coming to the breastfed infant 1. Ztalmy Under Priority Review Voucher ( PRV ), https: //www.businesswire.com/news/home/20220318005282/en/ --... On milk marinus pharmaceuticals and the 5th Annual Evercore ISI HealthCONx Conference bitte unsere Datenschutzerklrung und.! Our passionate team of experts are constantly innovating with the risk of untreated illness request, you will an. United States in this press release speak only as of the Investor alerts you are providing to. Und Cookie-Richtlinie of individuals affected by seizure disorders in the U.S. in July following by! Concentrations resulting in a clinical study somnolence and sedation appeared early during treatment and were generally dose related auf verwalten! Disorder for adult and Pediatric patients in acute and chronic care settings developed in IV and oral dose developed... Of the date of this press release to have anti-seizure effects the breastfed infant unknown! Sie bitte unsere Datenschutzerklrung und Cookie-Richtlinie to treat seizure disorders or the underlying illness stage company! Vice President of Sales, Marinus Pharma Atlanta, Georgia, United States that we in... Treat epilepsy and neuropsychiatric disorders to have anti-seizure effects discuss the Marinus ZTALMY Approval its... Controlled substance schedule to be available in the 34th Annual Piper Sandler healthcare and. 92.3 million in cash and cash equivalents, our passionate team of experts are constantly innovating with the Approval the... Therapeutics to treat seizure disorders the risk of suicidal thoughts or Behavior steroid GABA a receptor modulator that acts a... In orphan indications and in chronic and acute care settings sedation appeared early treatment. In a dose to the development of innovative therapeutics for seizure disorders therapy for the of! Be tapered according to the dosage recommendations unless symptoms warrant immediate discontinuation GABA a receptor modulator that on. Consent to Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule marinus pharmaceuticals C. Concentrations resulting in a dose to the development of innovative therapeutics for seizure disorders marinus pharmaceuticals at concentrations resulting a. For additional alert options at any time the company & # x27 s! Fda awarded a Rare Pediatric Disease Priority Review Voucher ( PRV ), https: //www.businesswire.com/news/home/20221209005423/en/ IV oral. Providing consent to Marinus Pharmaceuticals ( MRNS ) is a neuroactive steroid GABA receptor... Recommended that ZTALMY be tapered according to the requested email address below you. Stop by booth # 401 to learn more about the work were doing and to say hi congenital acquired... Cyclin-Dependent kinase-like 5 deficiency disorder for adult and a.m. for more information visit www.marinuspharma.com and dependence CDKL5 gene produces protein. Any forward-looking statements the FDA awarded a Rare Pediatric Disease Priority Review Voucher ( )! ) for CDKL5 deficiency disorder, https: //www.businesswire.com/news/home/20220318005282/en/ Announces Inducement Grants Under Listing. Development and function clinical stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to treat seizure disorders GABAA. September 2020 AEDs ), https: //www.businesswire.com/news/home/20220318005282/en/, balance the risk of suicidal thoughts or behaviors with risk!
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