MRNS Marinus Pharmaceuticals Inc.

13.2
+0.47  (+4%)
Previous Close 12.73
Open 12.75
52 Week Low 4.16
52 Week High 17.14
Market Cap $469,872,348
Shares 35,596,390
Float 35,526,486
Enterprise Value $368,897,260
Volume 277,436
Av. Daily Volume 598,410
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Upcoming Catalysts

Drug Stage Catalyst Date
Ganaxolone
Tuberous Sclerosis Complex
Phase 2
Phase 2
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Ganaxolone (Violet Study)
PCDH19-related epilepsy
Phase 3
Phase 3
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Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
NDA Filing
NDA Filing
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Ganaxolone (RAISE)
Refractory status epilepticus (RSE)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
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 is moving towards a pre-NDA meeting, targeted for the end of Q1, in support of NDA submission by the end of Q2

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company's pivotal Phase 3 Marigold Study on the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD) appear sufficient to support the filing of a New Drug Application (NDA). Adequacy of these data to support an approval of ganaxolone for the proposed indication will be a matter of…

    Marinus is moving towards a pre-NDA meeting, targeted for the end of Q1, in support of NDA submission by the end of Q2

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company's pivotal Phase 3 Marigold Study on the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD) appear sufficient to support the filing of a New Drug Application (NDA). Adequacy of these data to support an approval of ganaxolone for the proposed indication will be a matter of future FDA review.

    CDD is a rare, genetic epilepsy with refractory seizures. Marinus provided the data to the FDA in a briefing document meant to support a Type C meeting, and the FDA provided written preliminary comments in response. Based on this feedback, Marinus is targeting a pre-NDA meeting by the end of Q1 to support submission.

    "We are pleased with the FDA's assessment of the sufficiency of the efficacy and safety data from one Phase 3 clinical trial to support an NDA filing," said Scott Braunstein, M.D., Chief Executive Officer of Marinus. "We remain on track to submit the NDA for use of ganaxolone in CDD for FDA review by mid-2021 and look forward to continued advancement of ganaxolone as the first potential FDA approved treatment specifically indicated in patients diagnosed with CDD."

    In September, Marinus reported positive topline data from the Phase 3 Marigold Study, the first double-blind placebo-controlled trial to provide evidence of efficacy in CDD and the first Phase 3 trial to examine three times a day dosing of ganaxolone in pediatric patients.

    In the Phase 3 Marigold trial, patients treated with ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency, compared to a 4.0% reduction for those receiving the placebo, achieving the trial's primary endpoint (p=0.002). In this trial, ganaxolone was generally well tolerated with a safety profile consistent with previous clinical trials, with the most frequent adverse event being somnolence.

    "We see continued progress in our other development programs," continued Dr. Braunstein. "Marinus continues to initiate new sites to participate in the Phase 3 clinical trial of IV ganaxolone for the treatment of Refractory Status Epilepticus (RSE) or RAISE trial. While the COVID-19 pandemic is lengthening the time for new trial sites to open for enrollment, we do not anticipate this having major implications on the ultimate timing of trial results."

    "The Phase 2 Violet Study, evaluating both three times a day dosing of ganaxolone and the role of allopregnanolone sulfate as a biomarker in PCDH19-related epilepsy remains on track. In March, we plan to provide an update on this program," said Dr. Braunstein. "Additionally, we expect to report top line data from our Phase 2 Tuberous Sclerosis Complex trial by late Q2."

    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 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. Unlike benzodiazepines, ganaxolone exhibits antiseizure, antidepressant and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. More than 1,600 study participants, both adults and children, have received ganaxolone at therapeutically relevant dose levels and treatment regimens for up to four years.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare 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 and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company is initiating a Phase 3 trial in status epilepticus.

    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 clinical development plans for ganaxolone; our plans to have a pre-NDA meeting with FDA for submission of an NDA for use of ganaxolone in CDKL5 Deficiency Disorder (CDD) by the end of first quarter 2021; our expectations to file an NDA for ganaxolone in CDD by end of second quarter 2021; our ability to receive FDA approval of ganaxolone in CDD; our plan to provide an update on our Phase 2 Violet Study in March 2021; our expectations that COVID-19 will not have major implications on the ultimate timing of trial results for our RAISE Phase 3 clinical trial in Refractory Status Epilepticus; our expectation to report top line data from our Phase 2 Tuberous Sclerosis Complex trial by late second quarter 2021. 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. 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; clinical trial results may not support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the interpretation of clinical trial results and the ability of clinical trial results to support regulatory approval; our ability to obtain and maintain regulatory approval for our product candidate; delays, interruptions or failures in the manufacture and supply of our product candidate; our ability to raise additional capital; 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. 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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  2. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced that company management will present a corporate overview during the 39th Annual J.P. Morgan Healthcare Conference. An audio-only presentation will take place January 14, 2021 at 3:40 pm EST. Company management will also participate in the H.C. Wainwright Bioconnect 2021 Conference on January 11.

    Additional details can be found below:

    H.C. Wainwright Bioconnect 2021 Conference

    • Date and Time: On-demand starting Monday, January 11 6:00 am (EST)
    • Speakers: Scott Braunstein, M.D., Chief Executive Officer, Edward Smith, Chief Financial Officer, and Joseph Hulihan, M.D…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced that company management will present a corporate overview during the 39th Annual J.P. Morgan Healthcare Conference. An audio-only presentation will take place January 14, 2021 at 3:40 pm EST. Company management will also participate in the H.C. Wainwright Bioconnect 2021 Conference on January 11.

    Additional details can be found below:

    H.C. Wainwright Bioconnect 2021 Conference

    39th Annual J.P. Morgan Healthcare Conference

    Webcast and audio replays will be available following each event under the Investors & Media page of the Company's website at www.marinuspharma.com.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare 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, anti-depressant and anti-anxiety effects. Ganaxolone is being developed in IV and oral dose forms 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 and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company intends to initiate a Phase 3 trial in status epilepticus. For more information visit www.marinuspharma.com.

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  3. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has been selected for inclusion in the Nasdaq Biotechnology Index (NBI), which became effective prior to market open today.

    "On the tails of a momentous year, we are pleased to be included in the Nasdaq Biotechnology Index," said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. "Index inclusion recognizes our clinical progress and heightened investor awareness as we remain committed to rapidly advancing our pipeline in rare epilepsies and neuropsychiatric disorders."

    The NBI is designed to track the performance of a set of securities listed…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has been selected for inclusion in the Nasdaq Biotechnology Index (NBI), which became effective prior to market open today.

    "On the tails of a momentous year, we are pleased to be included in the Nasdaq Biotechnology Index," said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals. "Index inclusion recognizes our clinical progress and heightened investor awareness as we remain committed to rapidly advancing our pipeline in rare epilepsies and neuropsychiatric disorders."

    The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB).

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare 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, anti-depressant 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 and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company has also initiated a Phase 3 trial in 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 clinical development plans for ganaxolone. 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. 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; clinical trial results may not support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration 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; delays, interruptions or failures in the manufacture and supply of our product candidate; our ability to raise additional capital; 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. 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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  4. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced the pricing of an underwritten public offering of 5 million shares of its common stock for gross proceeds of $70 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Marinus. All of the shares of common stock are being offered by Marinus. The closing of the offering is expected to occur on or about December 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Marinus has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced the pricing of an underwritten public offering of 5 million shares of its common stock for gross proceeds of $70 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Marinus. All of the shares of common stock are being offered by Marinus. The closing of the offering is expected to occur on or about December 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Marinus has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock.

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

    The underwriters may offer the shares from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On December 7, 2020, the last sale price of the shares as reported on the Nasdaq Global Market was $15.61 per share.

    Marinus intends to use the net proceeds of the offering to fund the development of its product candidates and for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial expenditures, acquisitions of new technologies, products or businesses, and investments.

    The securities described above are being offered by Marinus pursuant to a shelf registration statement on Form S-3 (No. 333-239780) declared effective by the Securities and Exchange Commission (the "SEC") on July 27, 2020.

    A preliminary prospectus supplement relating to the offering was filed with the SEC on December 7, 2020 and is available on the SEC's website at http://www.sec.gov. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC's website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that Marinus has filed (or will file) with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about Marinus and the offering. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare 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, anti-depressant 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 and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company is initiating a Phase 3 trial in status epilepticus.

    Forward-Looking Statements

    To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the closing of the offering, as well as the anticipated use of proceeds for the offering and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Marinus' actual results to be materially different than those expressed in or implied by Marinus' forward-looking statements. For Marinus, this includes satisfaction of the customary closing conditions to the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility, the impact of general business and economic conditions, the expected gross proceeds from the offering and the intended use of proceeds of the offering. More detailed information on these and additional factors that could affect Marinus' actual results are described in Marinus' filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Marinus undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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  5. Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced an underwritten public offering of its common stock. All of the shares to be sold in the offering will be offered by Marinus. Marinus has granted the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

    Marinus intends to use the net proceeds of the offering to fund the development of its product candidates and for general corporate purposes, which may include working capital, capital expenditures, research and development…

    Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced an underwritten public offering of its common stock. All of the shares to be sold in the offering will be offered by Marinus. Marinus has granted the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares offered in the public offering.

    Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

    Marinus intends to use the net proceeds of the offering to fund the development of its product candidates and for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial expenditures, acquisitions of new technologies, products or businesses, and investments.

    The securities described above will be offered by Marinus pursuant to a shelf registration statement on Form S-3 (No. 333-239780) declared effective by the Securities and Exchange Commission (the "SEC") on July 27, 2020.

    The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 6th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Marinus Pharmaceuticals

    Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare 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, anti-depressant 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 and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company is initiating a Phase 3 trial in status epilepticus.

    Forward-Looking Statements

    To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the timing and success of the proposed offering, as well as the anticipated use of proceeds for the proposed offering and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Marinus' actual results to be materially different than those expressed in or implied by Marinus' forward-looking statements. For Marinus, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect Marinus' actual results are described in Marinus' filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Marinus undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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