Marinus Pharmaceuticals, Inc., a clinical stage pharmaceutical company, focuses on developing and commercializing therapeutics to treat rare seizure disorders. Its clinical stage product candidate, ganaxolone, is an allosteric modulator of GABAA, developed in formulations for two routes, including intravenous (IV) and oral for adult and pediatric patient populations in acute and chronic care, and in-patient and self-administered settings. The company's ganaxolone product candidate, acts at synaptic and extrasynaptic GABAA receptors, a target for its anti-seizure, antidepressant, and anxiolytic potential. It is developing ganaxolone for status epilepticus, cyclin dependent kinase like 5 deficiency disorder, PCDH19-related epilepsy, tuberous sclerosis complex, and postpartum depression. Marinus Pharmaceuticals, Inc. has license agreement with Purdue Neuroscience Company and CyDex Pharmaceuticals, Inc. The company was incorporated in 2003 and is headquartered in Radnor, Pennsylvania.
IPO Year: 2014
Exchange: NASDAQ
Website: marinuspharma.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
9/23/2024 | $6.00 | Perform → Outperform | Oppenheimer |
8/14/2024 | Buy → Neutral | Ladenburg Thalmann | |
4/16/2024 | $20.00 → $2.00 | Outperform → Neutral | Robert W. Baird |
4/15/2024 | $24.00 → $3.00 | Outperform → Sector Perform | RBC Capital Mkts |
8/11/2023 | $14.00 → $9.00 | Outperform → Perform | Oppenheimer |
1/20/2023 | $23.00 | Outperform | RBC Capital Mkts |
12/20/2021 | $32.00 → $30.00 | Outperform | SVB Leerink |
Truist Securities analyst Joon Lee maintains Marinus Pharma (NASDAQ:MRNS) with a Buy and maintains $10 price target.
HC Wainwright & Co. analyst Douglas Tsao reiterates Marinus Pharma (NASDAQ:MRNS) with a Buy and maintains $11 price target.
Monday, Marinus Pharmaceuticals Inc (NASDAQ:MRNS) announced topline results from the Phase 3 RAISE trial evaluating the safety and efficacy of intravenous (IV) ganaxolone for refractory status epilepticus (RSE). In the RAISE trial, patients with RSE who failed at least two antiseizure medications were randomized to IV ganaxolone or placebo in addition to standard-of-care treatment. The intent-to-treat population comprised 96 patients, 49 in the IV ganaxolone and 47 in the placebo arm. Related: Analysts Question Commercial Viability of Marinus’ IV Ganaxolone After Interim Analysis Miss. Topline data demonstrated that: A statistically significant proportion of patients had stat
RAISE trial met its first co-primary endpoint demonstrating rapid cessation of status epilepticus in a highly refractory patient population The trial failed to achieve statistical significance on the second co-primary endpoint of the proportion of patients not progressing to IV anesthesia Marinus will continue to prioritize the ZTALMY franchise and expansion opportunities in highly refractory, chronic epilepsies with Phase 3 TrustTSC topline data expected in the first half of Q4 2024 As a result of recently implemented cost reduction plans and financing activity, the Company projects cash runway into Q2 2025
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced completion of enrollment in the global Phase 3 TrustTSC trial evaluating oral ganaxolone for the treatment of seizures associated with tuberous sclerosis complex (TSC) in children and adults. "We are pleased to announce we have completed enrollment in our pivotal Phase 3 trial in tuberous sclerosis complex," said Alex Aimetti, Ph.D., Chief Scientific Officer at Marinus Pharmaceuticals. "The TrustTSC study enrolled highly refractory TSC patients experiencing a significant seizure burden despite treatment with multiple antise
HC Wainwright & Co. analyst Douglas Tsao reiterates Marinus Pharma (NASDAQ:MRNS) with a Buy and maintains $11 price target.
Marinus Pharma (NASDAQ:MRNS) reported quarterly losses of $(0.68) per share which missed the analyst consensus estimate of $(0.66) by 3.03 percent. This is a 1.49 percent decrease over losses of $(0.67) per share from the same period last year. The company reported quarterly sales of $7.679 million which missed the analyst consensus estimate of $9.125 million by 15.85 percent. This is a 26.02 percent decrease over sales of $10.380 million the same period last year.
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ZTALMY® (ganaxolone) Q3 2024 net product revenue of $8.5 million representing growth of 56% versus Q3 2023 Narrowing full year 2024 ZTALMY net product revenue guidance to $33 to $34 million Reported results from Phase 3 TrustTSC trial and commenced process to explore strategic alternatives Marinus continues to support the commercial growth of ZTALMY; further ganaxolone clinical development has been suspended Scheduled to meet with FDA Q4 2024 to discuss a potential path forward for IV ganaxolone in refractory status epilepticus Cost reduction plans implemented with cash runway expected into Q2 2025; cash and cash equivalents of $42.2 million as of September 30, 2024 Marin
Trial did not meet the primary endpoint of percent change in 28-day TSC-associated seizure frequency (p=0.09); results showed numerically higher response rates for ganaxolone than placebo Ganaxolone was generally well-tolerated in TrustTSC with a safety profile consistent with previous clinical trials Cost reduction activities are underway Marinus has engaged Barclays as an advisor to assist with evaluating strategic alternatives Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that the Phase 3 TrustTSC trial evaluating oral ganaxolone for the treatment of seizures as
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today presented new data from the pivotal Phase 3 RAISE trial evaluating intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE) at the Neurocritical Care Society (NCS) Annual Meeting. Topline data demonstrating that the trial met one of two co-primary endpoints were reported in June 2024. In the RAISE trial (NCT04391569), patients with RSE that failed at least two antiseizure medications were randomized to IV ganaxolone or placebo in addition to standard of care treatment. The co-primary endpoints were the pr
New U.S. patent issued for ZTALMY® (ganaxolone) oral titration regimens cover the treatment of a range of epilepsy disorders, expiring September 2042 Marinus continues to grow its IP portfolio to protect its scientific innovation Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced it has added to its intellectual property (IP) estate with a new patent issued by the United States Patent and Trademark Office (USPTO) for ZTALMY® (ganaxolone) oral titration regimens covering the treatment of a range of epilepsy disorders, including CDKL5 deficiency disorder, tuberous sclerosis
Includes additional data from the Phase 3 RAISE trial in refractory status epilepticus (SE) and data from a retrospective claims-based analysis on the management of SE Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that additional data from the Phase 3 RAISE trial in refractory status epilepticus and retrospective claims-based data from patients with status epilepticus will be presented at the upcoming Neurocritical Care Society (NCS) 22nd Annual Meeting, being held October 14-17 in San Diego, California. Presentation details are as follows: Podium Presentation Det
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 one new employee. The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 9,800 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 $1.85 per share, which is equal to the closing price of the Common Stock on October 7, 2024 (d
Enrollment complete and on track to report topline data from the TrustTSC trial in tuberous sclerosis complex (TSC) in the first half of Q4 with NDA filing targeted for April 2025 TrustTSC maintained a double-blind discontinuation rate of 6.2% with 93% of patients continuing to the open-label extension Patients who completed Marinus' Phase 2 TSC trial and entered the long-term extension demonstrated a median reduction in seizure frequency of 56% within two years (n=9) Real-world claims data support a significant unmet need in TSC with approximately 26% of patients having tried and failed three or more antiseizure medications Notice of Allowance received from the USPTO for a patent appli
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced agenda topics and speakers for its upcoming Investor & Analyst Day on Friday, September 20 from 9:00 a.m. to 12:00 p.m. ET in New York. The event will feature presentations from Marinus' leadership and key opinion leaders (KOLs) with a focus on the development program and commercial launch preparations for ZTALMY® (ganaxolone) oral suspension CV in tuberous sclerosis complex (TSC). Marinus' leadership will provide updated baseline patient demographics and characteristics from the Phase 3 TrustTSC trial and discuss the mark
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that management will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference on Thursday, September 19, 2024, at 10:20 a.m. ET. A link to the event can be accessed on the Investors and Media page of Marinus' website at ir.marinuspharma.com/events-and-presentations. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 90 days. About Marinus Pharmaceuticals Marinus is a commercial-stage pharmaceutical company dedicated to th
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, will host an Investor and Analyst Day on Friday, September 20 from 9:00 a.m. to 12:00 p.m. Eastern Time in New York and via webcast. The event will feature presentations from Marinus management and key opinion leaders with a focus on the Company's development program for ZTALMY® (ganaxolone) oral suspension CV in tuberous sclerosis complex (TSC) ahead of the Phase 3 TrustTSC trial data readout anticipated in the first half of the fourth quarter of 2024. In-person attendance is open to invited research analysts and institutional investo
Executive with Strong Track Record in Advancing Pipelines Through Clinical Development DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, announced today the appointment of Lorianne Masuoka, M.D. as Chief Medical Officer. Dr. Masuoka is a board-certified neurologist with more than 25 years of experience and a successful track record of managing clinical programs from early stage to drug approvals and strategic alliances. "We are delighted to have Lorianne join our executive leadership team," said Rick Pauls, DiaMedica's President and Chief Executive Officer. "Sh
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Sarah Noonberg, M.D., Ph.D., to its Board of Directors. "Sarah is an accomplished healthcare executive with extensive global clinical development and corporate strategy experience," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "With a track record of successfully advancing programs in various therapeutic areas using diverse modalities, a deep understanding of orphan diseases and over a decade of experience as a hospitalist physician, her unique perspective will be invalu
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Marvin H. Johnson, Jr. to its Board of Directors. "With over 34 years of diverse commercial operations experience at Merck & Co., we are delighted that Marvin is joining the Marinus Board," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "His impressive background launching products across multiple therapeutic categories, including neurology and acute care, will be invaluable in supporting the continued commercial success of ZTALMY® and in preparing for a potential hospital
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the appointment of Christine Silverstein to its Board of Directors and Audit Committee. "Ms. Silverstein brings to our Board deep capital markets expertise and extensive corporate strategic planning, business development, compliance and risk management experience," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "Her financial and strategic acumen combined with her background in neurology and rare disease make her an outstanding addition to Marinus' Board of Directors as we seek to grow the ZT
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that the Board of Directors has appointed Chief Executive Officer (CEO) and Board Director, Scott Braunstein, M.D., as Chairman of the Board. Dr. Braunstein succeeds Nicole Vitullo, who has retired from the Board of Directors following a 17-year tenure, including the past three years as Chairwoman. Marinus also announced two other departures from the Board, Michael Dougherty, who has retired, and Santiago Arroyo, M.D., Ph.D., who has stepped down following the announcement of his appointment as Chief Medical Officer of a Cambrid
Anticipate initiating a Phase 3 trial of adjunctive ganaxolone in tuberous sclerosis complex (TSC) in Q3 2021, targeting first patient enrolled during Q4 2021; continue to expect topline Phase 2, open label data in Q3 2021 European Medicines Agency (EMA) is expected to accept accelerated assessment of ganaxolone for the treatment of seizures associated with CDKL5 deficiency disorder (CDD); Marinus plans to submit a marketing authorization application to the EMA by the end of Q3 2021 Received notice of allowance from the U.S. Patent and Trademark Office for refractory status epilepticus (RSE) dosing and method of treatment patent application U.S. Food and Drug Administration (FDA) in
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 Ex
BLACKSBURG, Va., May 19, 2021 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc (NASDAQ:LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, today announced the appointment of Tim M. Mayleben to its Board of Directors. Mr. Mayleben joins Landos with more than 20 years of executive experience leading development activities as well as successfully spearheading clinical and business strategies within the life sciences industry. "We are pleased to introduce Tim as the newest Board member, Compensation Committee Chair and member of the Audit Committee," commented Josep Bassaganya-Riera, Chairman, President and
Strategic credit financing agreement with funds managed by Oaktree Capital Management, L.P. ("Oaktree") will provide up to $125 million to support continued development and commercial readiness of both the oral and IV ganaxolone programs On track to submit NDA for use of ganaxolone in CDKL5 deficiency disorder (CDD) in mid-2021; recent NDA preparation and review resulted in a final p-value of p=0.0036, not affecting statistical conclusions of the Phase 3 Marigold Study Patients in the Marigold open label extension treated with ganaxolone for at least 12 months experienced a median 49.6% reduction in major motor seizure frequency (n=48) CDD EU submission on track for end of Q3 2021
RADNOR, Pa.--(BUSINESS WIRE)--Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced the appointment of Saraswathy (“Sara”) Nochur, Ph.D., to its Board of Directors. “Sara brings tremendous experience and success in managing global regulatory and drug development and has been involved in the approval of several novel drugs for rare diseases,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “She was instrumental in developing global innovative regulatory strategies for the development and approval of a new class of medicines based on RNA interfe
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Oppenheimer upgraded Marinus Pharmaceuticals from Perform to Outperform and set a new price target of $6.00
Ladenburg Thalmann downgraded Marinus Pharmaceuticals from Buy to Neutral
Robert W. Baird downgraded Marinus Pharmaceuticals from Outperform to Neutral and set a new price target of $2.00 from $20.00 previously
RBC Capital Mkts downgraded Marinus Pharmaceuticals from Outperform to Sector Perform and set a new price target of $3.00 from $24.00 previously
Oppenheimer downgraded Marinus Pharmaceuticals from Outperform to Perform and set a new price target of $9.00 from $14.00 previously
RBC Capital Mkts initiated coverage of Marinus Pharmaceuticals with a rating of Outperform and set a new price target of $23.00
SVB Leerink reiterated coverage of Marinus Pharmaceuticals with a rating of Outperform and set a new price target of $30.00 from $32.00 previously
HC Wainwright resumed coverage of Marinus Pharmaceuticals with a rating of Buy and set a new price target of $38.00 from $35.00 previously
ZTALMY® (ganaxolone) Q2 2024 net product revenue of $8.0 million representing strong growth of 87% versus Q2 2023 On track to achieve full year 2024 ZTALMY net product revenue guidance of between $33 and $35 million Completed enrollment in the Phase 3 TrustTSC trial of oral ganaxolone in tuberous sclerosis complex (TSC) with topline data expected in the first half of Q4 2024 Expanded ZTALMY global footprint with activation of managed access programs for MENA, Russia and Canada with upcoming commercial launches anticipated in Europe and China Succeeded in post-grant review challenge of Ovid Therapeutics' U.S. Patent 11,395,817 for IV ganaxolone in the treatment of status epilept
Conference call at 4:30 p.m. Eastern Time today Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today reported financial results for the three and six months ended June 30, 2024, and provided an operating forecast and business update. Ligand management will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss this announcement and answer questions. "We had a strong quarter and are on track to meet the long-term growth objectives we outlined in December," said Todd Davis, CEO of Ligand. "We added four new commercial-stage programs in the first half of this year, including QARZIBA®, an orphan oncology product we acquired following the APEIRON Biologics transacti
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it plans to release financial results for the second quarter ended June 30, 2024 on August 13, 2024. The Company will host a conference call at 8:30 a.m. E.T. on August 13, 2024, to provide a business update and discuss financial results. Tuesday, August 13, 8:30 a.m. E.T. Domestic: (877) 405-1242 International: (201) 389-0852 Webcast Registration: Click Here An archived version of the call will be available approximately two hours after the completion of the event on the Marinus website at ir.marinuspharma.com/e
Conference Call and Webcast March 20 at 8:00 AM Eastern Time / 7:00 AM Central Time ReMEDy2 Clinical Site Activation Commenced in December 2023 Strengthened Management Team with Lorianne Masuoka, M.D., as Chief Medical Officer $53 Million Cash with Runway to 2026 DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the year ended December 31, 2023. Management will host a conference call Wednesday, March 20, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and full
Phase 3 RAISE trial interim analysis enrollment target achieved with Data Monitoring Committee (DMC) review scheduled and topline results expected in first half of Q2 2024 Phase 3 TrustTSC trial approximately 85% enrolled with topline data now expected in first half of Q4 2024 ZTALMY® (ganaxolone) net product revenue of $6.6 million for Q4 2023 and $19.6 million for the full year ended December 31, 2023 Full year 2024 U.S. ZTALMY net product revenue guidance of between $32 and $34 million Cash runway projected into Q4 2024 with cash, cash equivalents and short-term investments of $150.3 million as of December 31, 2023 Marinus to host conference call today at 4:30 p.m. ET
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it plans to release financial results for the fourth quarter and full year ended December 31, 2023 on March 5, 2024. The Company will host a conference call at 4:30 p.m. E.T. on March 5, 2024, to provide a business update and discuss financial results. Tuesday, March 5, 4:30 p.m. E.T. Domestic: (888) 550-5280 International: (646) 960-0813 Webcast Registration: https://events.q4inc.com/attendee/513453609 Conference ID: 2696394 An archived version of the call will be available approximately two hours after the com
ZTALMY® (ganaxolone) Q3 net product revenue of $5.4 million; 2023 net product revenue guidance increased to between $18.5 and $19 million Over 75% of patients required for the interim analysis are now enrolled in the Phase 3 RAISE trial in refractory status epilepticus; if the trial meets pre-defined stopping criteria at the interim analysis, topline data now anticipated Q2 2024 Initiated the Marinus Access Program to expand global availability of ZTALMY Cash runway projected into Q4 2024 with cash, cash equivalents and short-term investments of $176.4 million as of September 30, 2023 Marinus to host conference call on November 7, 2023, at 8:30 a.m. ET Marinus Pharmaceutical
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it plans to release financial results for the third quarter ended September 30, 2023 on November 7, 2023. The Company will host a conference call at 8:30 a.m. Eastern Time on November 7, 2023. Participants may access the conference call via webcast on the Investors and Media page of Marinus' website at ir.marinuspharma.com/events-and-presentations. An archived version of the call will be available approximately two hours after the completion of the event on the website. About Marinus Pharmaceuticals Marinus is a c
ZTALMY® (ganaxolone) second quarter net product revenue of $4.2 million; 2023 net product revenue guidance increased to between $17 and $18.5 million European Commission approved ZTALMY in CDKL5 deficiency disorder Interim analysis for the Phase 3 refractory status epilepticus trial now expected Q1 2024 First patient dosed in MAD trial with second generation ganaxolone formulation New emergency IND dosing paradigm for super refractory status epilepticus showing encouraging initial results Granted a new method of use patent by USPTO for ganaxolone in tuberous sclerosis complex Cash runway expected into second half of 2024 with cash, cash equivalents and short-term investme
Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it plans to release financial results for the second quarter ended June 30, 2023 on August 10, 2023. The Company will host a conference call at 8:30 a.m. Eastern Time on August 10, 2023. Participants may access the conference call via webcast on the Investors and Media page of Marinus' website at ir.marinuspharma.com/events-and-presentations. An archived version of the call will be available approximately two hours after the completion of the event on the website. About Marinus Pharmaceuticals Marinus is a commer