MRNS Marinus Pharmaceuticals Inc.

12.8
-1  -7%
Previous Close 13.8
Open 13.9
52 Week Low 6.56
52 Week High 20.04
Market Cap $468,969,510
Shares 36,638,243
Float 36,588,832
Enterprise Value $434,959,174
Volume 274,976
Av. Daily Volume 200,718
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Upcoming Catalysts

Drug Stage Catalyst Date
Ganaxolone
Tuberous Sclerosis Complex
Phase 2
Phase 2
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Ganaxolone (RAISE)
Refractory status epilepticus (RSE)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
NDA Filing
NDA Filing
NDA filing announced August 3, 2021.
Ganaxolone (Violet Study)
PCDH19-related epilepsy
Phase 2
Phase 2
Phase 2 trial showed a median 61.5% reduction in seizure frequency for ganaxolone compared to 24.0% for placebo (p=0.17).
Ganaxolone - Magnolia
Postpartum depression
Phase 2
Phase 2
Phase 2 negative data released July 23, 2019.
Ganaxolone
Focal onset seizures
Phase 3
Phase 3
Phase 3 data did not meet endpoints - June 2016
Ganaxolone
Fragile X Syndrome
Phase 2
Phase 2
Phase 2 data released June 2016. Primary endpoint not met but intends to advance development

Latest News

  1. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced plans to release financial results for the second quarter ended June 30, 2021 before the market opens on August 10, 2021. The company will host a conference call at 8:30 a.m. Eastern Time on August 10, 2021, to provide a business update and discuss the financial results.

    Tuesday, August 10: 8:30 a.m. Eastern Time

    Domestic: (833) 979-2765
    International: (343) 761-2590
    Webcast Link: https://event.on24.com/wcc/r/3194348/D7BBD3D17DC6E8447B1781C07F60BE82
    Conference ID: 4254409

    About Marinus Pharmaceuticals
    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced plans to release financial results for the second quarter ended June 30, 2021 before the market opens on August 10, 2021. The company will host a conference call at 8:30 a.m. Eastern Time on August 10, 2021, to provide a business update and discuss the financial results.

    Tuesday, August 10: 8:30 a.m. Eastern Time

    Domestic: (833) 979-2765

    International: (343) 761-2590

    Webcast Link: https://event.on24.com/wcc/r/3194348/D7BBD3D17DC6E8447B1781C07F60BE82

    Conference ID: 4254409

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year and is conducting a Phase 2 trial in tuberous sclerosis complex and a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.

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  2. Orion obtains rights to commercialize both the oral and IV franchises of ganaxolone in Europe

    Collaboration supports mid-2022 European launch of oral ganaxolone for CDKL5 deficiency disorder, if approved; leverages Orion's expertise in rare orphan diseases, antiepileptics and European commercialization

    Marinus to receive €25 million (~$30 million) as an upfront fee and is eligible to receive up to €97 million (~$115 million) in R&D reimbursement, development and commercialization milestone payments, as well as tiered double-digit royalties on net sales in the European Economic Area, UK and Switzerland

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure…

    Orion obtains rights to commercialize both the oral and IV franchises of ganaxolone in Europe

    Collaboration supports mid-2022 European launch of oral ganaxolone for CDKL5 deficiency disorder, if approved; leverages Orion's expertise in rare orphan diseases, antiepileptics and European commercialization

    Marinus to receive €25 million (~$30 million) as an upfront fee and is eligible to receive up to €97 million (~$115 million) in R&D reimbursement, development and commercialization milestone payments, as well as tiered double-digit royalties on net sales in the European Economic Area, UK and Switzerland

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has entered into an agreement with Orion Corporation whereby Orion received exclusive rights to commercialize the oral and intravenous (IV) dose formulations of ganaxolone in the European Economic Area, United Kingdom and Switzerland for CDKL5 deficiency disorder (CDD), tuberous sclerosis complex (TSC) and refractory status epilepticus (RSE).

    "Orion has a strong presence across Europe in rare neurological disorders, brings an extensive commercial infrastructure and is an ideal partner to introduce ganaxolone in Europe," said Scott Braunstein, M.D., Chief Executive Officer of Marinus. "This collaboration not only serves as an important step in our global development strategy for ganaxolone, it also represents the confidence Orion has in its potential. I believe that the collaboration allows both parties to share in the long-term success of ganaxolone."

    Under the agreement, Orion will pay Marinus €25 million (~$30 million) in cash as an upfront fee. Marinus is eligible to receive up to an additional €97 million (~$115 million) in R&D reimbursement and cash milestone payments based on specific clinical and commercial achievements, as well as tiered royalty payments based on net sales ranging from the low double-digits to high teens for the oral programs and the low double-digits to low 20s for the IV program. The upfront payment is subject to certain provisions associated with additional pre-clinical testing by Marinus, which is expected to be completed in Q1 2022.

    Satu Ahomäki, Senior Vice President, Commercial Operations of Orion Corporation said, "We are pleased to be the partner of choice for Marinus in Europe. What we have seen so far with ganaxolone is encouraging and signifies an ongoing commitment to the rare epilepsy communities. I look forward to these efforts to advance effective medicines for these disorders. Ganaxolone could be a promising treatment option for patients suffering from rare epilepsies."

    As part of the agreement, Marinus will continue to be responsible for clinical development of ganaxolone, as well as regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA). Marinus expects to file a European marketing authorization application (MAA) for ganaxolone for the treatment of seizures associated with CDD by the end of Q3 2021. Marinus will continue to manufacture and supply product to Orion pursuant to a supply agreement between the parties. Ganaxolone is expected to have at least 10 years of regulatory data protection in Europe.

    Orion will be responsible for all pricing and reimbursement approvals as well as commercialization of ganaxolone in the European Economic Area (comprised of all 27 members of the European Union, Iceland, Liechtenstein and Norway). Additional territories include the United Kingdom and Switzerland. A Joint Steering Committee, comprised of two representatives from each party, will be set up to monitor and coordinate the development and commercialization activities.

    "We believe that Orion's commercial leadership has exceptional expertise in rare orphan diseases as well as a significant hospital and ICU presence to support development of IV ganaxolone alongside our oral franchise," said Christy Shafer, Chief Commercial Officer of Marinus. "We remain committed to identifying opportunities throughout the rest of the world to help improve the lives of patients suffering from rare genetic epilepsies and seizure disorders."

    Guggenheim Securities, LLC served as the exclusive financial advisor to Marinus in connection with the collaboration transaction.

    Marinus plans to host a conference call following the company's upcoming second quarter 2021 financial results and business update on August 10, 2021, at 8:30 a.m. ET. Webcast details to follow.

    About Ganaxolone

    Ganaxolone, a positive allosteric modulator of GABAA receptors, is an investigational product being developed in intravenous and oral formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been studied in more than 1,800 pediatric and adult subjects across various indications at therapeutically relevant dose levels and treatment regimens for up to more than two years.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year and is conducting a Phase 2 trial in tuberous sclerosis complex and a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.

    About Orion Corporation

    Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is continuously developing new drugs and treatment methods. The core therapy areas of Orion's pharmaceutical R&D are neurological disorders, oncology and respiratory diseases for which Orion develops inhaled pulmonary medication. Orion's net sales in 2020 amounted to EUR 1,078 million and the company had about 3,300 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki.

    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. 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. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expected clinical development plans, our expectation regarding regulatory communications and submissions and product launches for ganaxolone, and the timing thereof, including the expectation to file a MAA with the EMA for ganaxolone for the treatment of seizures associated with CDD by the end of Q3 2021 and to have additional pre-clinical testing completed in Q1 2022; our expectations regarding the Orion collaboration, including the expected benefits of such collaboration and receipt of an upfront fee and potential R&D reimbursement and milestone and royalty payments thereunder; our expectation that ganaxolone is expected to have at least 10 years of regulatory data protection in Europe; the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications; our expectation to identify opportunities throughout the rest of the world to help improve the lives of more patients, including additional collaborations and global expanded access programs; and our strategy, business plans and focus.

    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. Such risks and uncertainties include, among others, 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 company's product candidates, and the company's ability to service those markets; the company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company's ability to obtain additional funding to support its clinical development programs; the company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the company's product candidates; the potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms; the potential for Orion to recoup a percentage of the upfront fee depending on the additional pre-clinical testing expected to be completed in Q1 2022; the effect of the COVID-19 pandemic on our business, the medical community 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. This list is not exhaustive and these and other risks are described in the company's 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. Any forward-looking statements that the company makes in this press release speak only as of the date of this press release. The company assumes 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.

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  3. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy. An NDA filing notification letter from the FDA is expected before the end of Q3 2021. If the NDA is accepted for filing by the FDA, this will enable the company to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management, L.P., on or before December 31, 2021, subject to the satisfaction of…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy. An NDA filing notification letter from the FDA is expected before the end of Q3 2021. If the NDA is accepted for filing by the FDA, this will enable the company to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management, L.P., on or before December 31, 2021, subject to the satisfaction of certain customary conditions described in the credit agreement.

    "We have been diligently focused on advancing ganaxolone's clinical development for patients suffering from CDD, a devastating disease with high unmet medical need, and are pleased to have reached this important milestone," said Joseph Hulihan, M.D., Chief Medical Officer of Marinus. "We look forward to working with the FDA in their review process and remain focused on preparing for the anticipated U.S. launch. With our European commercial partner in place, we are equally committed to advancing ganaxolone for CDD patients in markets outside the U.S. and plan to submit a marketing authorization application to the European Medicines Agency later this year."

    The NDA is supported by data from the Phase 3 Marigold trial, a double-blind placebo-controlled trial in which 101 patients treated with ganaxolone showed a 30.7% median reduction in 28-day major motor seizure frequency, compared to a 6.9% reduction for those receiving placebo, achieving the trial's primary endpoint (p=0.0036). Patients in the Marigold open label extension study treated with ganaxolone for at least 12 months (n=48) experienced a median 49.6% reduction in major motor seizure frequency. Ganaxolone was generally well-tolerated with a safety profile consistent with previous clinical trials, with the most frequent adverse event being somnolence.

    The NDA includes a request for Priority Review, which, if granted, accelerates the timing of the FDA's goal for review of the application to six months following the end of the 60-day filing review period rather than the standard 10 month review. Priority Review status is designated for drugs that may offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition.

    The NDA also includes a request for a Rare Pediatric Disease Priority Review Voucher (PRV). The PRV program is designed to encourage development of new drugs and biologics for the prevention or treatment of rare pediatric diseases. Marinus received Rare Pediatric Disease (RPD) Designation from the FDA for ganaxolone for the treatment of seizures associated with CDD in July 2020. If the ganaxolone application is approved and the PRV is granted, Marinus may use it to obtain priority review for a subsequent human drug or biologic application or can sell or transfer the PRV to a third party.

    Pipeline and Corporate Update

    Due to COVID-19 priorities in several academic medical centers participating in the Phase 3 RAndomized Therapy In Status Epilepticus (RAISE) trial, including staff turnover and the need for clinical sites to devote significant resources to patients with COVID-19, the trial has experienced site initiation and enrollment delays. Given these most recent challenges, which heightened in the second quarter of this year, Marinus is shifting its top-line data readout for the RAISE trial to 2H 2022. The company now expects the vast majority of sites to be open by end of Q3 2021.

    Marinus recently announced an agreement with Finland-based pharmaceutical company, Orion Corporation, in which Orion received exclusive rights to commercialize the oral and intravenous (IV) dose formulations of ganaxolone in Europe for CDKL5 deficiency disorder, tuberous sclerosis complex and refractory status epilepticus. Under the agreement, Orion will pay Marinus €25 million (~$30 million) in cash as an upfront fee. Marinus is eligible to receive up to an additional €97 million (~$115 million) in R&D reimbursement and cash milestone payments based on specific clinical and commercial achievements, as well as tiered royalty payments based on net sales that could reach the high teens for the oral programs and low 20s for the IV program. Further details are available in Marinus' press release distributed August 3, 2021 (Marinus Pharmaceuticals Announces Exclusive Collaboration with Orion Corporation for European Commercialization of Ganaxolone).

    About CDKL5 Deficiency Disorder

    CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder that is caused by a mutation of the cyclin‑dependent kinase‑like 5 (CDKL5) gene, located on the X chromosome. CDD is characterized by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment. Most children affected by CDD cannot walk, talk, or feed themselves. Currently, there are no therapies approved specifically for CDD.

    About Ganaxolone

    Ganaxolone, a positive allosteric modulator of GABAA receptors, is an investigational product being developed in intravenous and oral formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone exhibits anti-seizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been studied in more than 1,800 pediatric and adult subjects across various indications at therapeutically relevant dose levels and treatment regimens for up to more than two years.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year and is conducting a Phase 2 trial in tuberous sclerosis complex and a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.

    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. 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. Examples of forward-looking statements contained in this press release include, among others, statements regarding the potential timeline for FDA review of the NDA for ganaxolone in CDD, including whether and when the FDA will determine that the NDA is acceptable for filing; the timing of submission of an MAA for ganaxolone to the EMA; the potential for the receipt of Priority Review from the FDA; our expectation regarding the opening of clinical trial sites by the end of Q3 2021; our expectations regarding the Orion collaboration, including the expected benefits of such collaboration and receipt of an upfront fee and potential R&D reimbursement and milestone and royalty payments thereunder; our expectations with respect to our clinical development plans, regulatory communications and submissions and product launches for ganaxolone, and the timing thereof; and the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications.

    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. Such risks and uncertainties include, among others, the risk that the timing of FDA's review of the NDA will be delayed or that the NDA is not accepted for filing by the FDA; the risk that the FDA will require additional clinical trials or data; any delays in acceptance and review of the NDA submission by the FDA for any reason, including the COVID-19 pandemic; the timing of regulatory filings, including the timing of filing the ganaxolone MAA with the EMA; the potential that regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidate; 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 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 company's product candidates, and the company's ability to service those markets; the company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company's ability to obtain additional funding to support its clinical development programs; the company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the company's product candidates; the potential for Orion to breach the collaboration or terminate the agreement in accordance with its terms; the potential for Orion to recoup a percentage of the upfront fee depending on the additional pre-clinical testing expected to be completed in Q1 2022; 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. This list is not exhaustive and these and other risks are described in the company's 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. Any forward-looking statements that the company makes in this press release speak only as of the date of this press release. The company assumes 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.

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  4. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Santiago Arroyo, M.D., Ph.D., to its Board of Directors. Dr. Arroyo brings more than 30 years of experience in academic neurology and pharmaceutical research and development.

    "Santiago's expansive background in leadership roles at global biopharmaceutical companies, along with his expertise as a neurologist in the hospital setting and serving as principal investigator on multiple late-stage drug trials, will be instrumental as Marinus continues to grow its pipeline," said Scott Braunstein, M.D., Chief Executive Officer of Marinus. "With his deep understanding…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Santiago Arroyo, M.D., Ph.D., to its Board of Directors. Dr. Arroyo brings more than 30 years of experience in academic neurology and pharmaceutical research and development.

    "Santiago's expansive background in leadership roles at global biopharmaceutical companies, along with his expertise as a neurologist in the hospital setting and serving as principal investigator on multiple late-stage drug trials, will be instrumental as Marinus continues to grow its pipeline," said Scott Braunstein, M.D., Chief Executive Officer of Marinus. "With his deep understanding of successful clinical development and insights in pediatric and adult epilepsy and electrophysiology, we believe he will provide a valuable perspective to our Board and will be a tremendous asset as we expand into new indications."

    Dr. Arroyo has had an extensive career in academic neurology and clinical research and development. Before joining the pharmaceutical industry, Dr. Arroyo was an instructor in neurology at The Johns Hopkins Hospital and helped set up and run the epilepsy programs at the Medical College of Wisconsin and Hospital Clinic of Barcelona, Spain. Most recently, he served as Chief Medical Officer of Momenta Pharmaceuticals (acquired in 2020 by Johnson & Johnson). Prior to his role at Momenta Pharmaceuticals, Dr. Arroyo served as Chief Medical Officer of Boston Pharmaceuticals, focusing on the therapeutic areas of immunology, oncology, and infectious diseases. Dr. Arroyo also held the roles of Senior Vice President, Head of Clinical Research and Chief Medical Officer of Biotherapeutics and Pharmatherapeutics at Pfizer Inc., in the areas of pain and neuroscience, cardiovascular and metabolic disease, regenerative medicine and rare diseases. He was therapeutic area head for neurosciences, discovery medicine and clinical pharmacology at Bristol-Myers Squibb and neurology global therapeutic area head for Eisai Global Clinical Development. Dr. Arroyo currently sits on the Board of the Danish biopharmaceutical company, Lundbeck. He received his medical degree from the Autonomous University of Madrid and his Ph.D. from the University of Barcelona, Spain.

    "I'm delighted to join Marinus' Board of Directors at this exciting juncture, as Marinus establishes its footprint in epilepsy, and ahead of its first potential launch next year," said Dr. Arroyo. "With compelling clinical data and a strong leadership team in place, I look forward to contributing to the next phase of the company's evolution, with the execution of several early-to-late-stage development activities that have the potential to change patients' lives."

    Concurrent with Dr. Arroyo's appointment, Enrique J. Carrazana, M.D. has stepped down from the Board, effective as of June 30, 2021. Dr. Carrazana served on the Marinus Board of Directors for eight years and was instrumental in the company's current pursuit of therapies for both rare genetic disorders and status epilepticus.

    "We are grateful for Dr. Carrazana's service and valuable contributions to Marinus over the last several years," said Dr. Braunstein. "His commitment and guidance have been instrumental in growing the company to where we are today, and I look forward to his continued success."

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder last year, is conducting a Phase 2 trial in tuberous sclerosis complex and has recently disclosed top-line results from its Phase 2 proof-of-concept trial in PCDH19-related epilepsy. The company has initiated a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.

    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. 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. Examples of forward-looking statements contained in this press release include, among others, statements regarding 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 regarding the Oaktree credit facility and its effects on our cash runway and business plans; our expectations that our cash and cash equivalents combined with the net upfront proceeds of the Oaktree credit facility will be sufficient to fund our operating expenses and capital expenditures through the second quarter of 2022; and the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications.

    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. Such risks and uncertainties include, among others, 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 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 company's product candidates, and the company's ability to service those markets; the company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the company's ability to obtain additional funding to support its clinical development programs; the company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the company's product candidates; the effect of the COVID-19 pandemic on our business, the medical community 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. This list is not exhaustive and these and other risks are described in the company's 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. Any forward-looking statements that the company makes in this press release speak only as of the date of this press release. The company assumes 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.

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  5. 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 five new employees. The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 29,063 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).

    These stock option grants have an exercise price of $18.50 per share, which is equal to the closing price of the Common Stock on June 18, 2021 (date of grant for such stock options). All of the…

    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 five new employees. The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 29,063 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).

    These stock option grants have an exercise price of $18.50 per share, which is equal to the closing price of the Common Stock on June 18, 2021 (date of grant for such stock options). 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 employee's 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 at the end of each month following such anniversary, subject to the applicable employee's continued employment with Marinus on such vesting dates. 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. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone 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. Marinus recently completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder, is conducting a Phase 2 trial in tuberous sclerosis complex and has recently disclosed top-line results from its Phase 2 proof-of-concept trial in PCDH19-related epilepsy. The company has initiated a Phase 3 trial in refractory status epilepticus. For more information visit www.marinuspharma.com.

    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. 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 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. Marinus undertakes no obligation to update or revise any forward-looking statements. 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.

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