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Marinus (MRNS) Down 83% on Lead Drug Falling Short in Seizure Study
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Shares of Marinus Pharmaceuticals (MRNS - Free Report) plummeted 83% on Monday after management provided an interim analysis of results from the pivotal phase III RAISE study evaluating lead drug ganaxolone in refractory status epilepticus (RSE).
The RAISE study, which evaluated an intravenous (IV) formulation of ganaxolone, did not meet the pre-defined ‘stopping’ criteria in RSE patients.
While an independent data monitoring committee (IDMC) recommended continuing the RAISE study, management has decided to stop enrolling patients in the study of approximately 100 patients.
A life-threatening condition, status epilepticus is marked by seizures that last longer than five minutes or more than one seizure within five minutes. Per management, the condition affects up to 150,000 patients every year in the United States alone. Patients with this condition who do not respond to first-line or second-line treatments are considered to have RSE.
An oral formulation of ganaxolone has been approved in the United States since 2022 to treat seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older. This version of ganaxolone is currently being marketed under the trade name Ztalmy.
Currently, ganaxolone is the sole marketed as well as the only pipeline drug in Marinus’ portfolio. The pipeline setback in RSE indication casts doubt on the IV formulation of the drug. Marinus expects to report topline data from the RAISE study later this summer, based on which it will determine whether to advance the development of the IV formulation of the drug.
The disappointing RAISE study results also cast doubt on Marinus’ second-generation ganaxolone formulation, which aims to provide improved pharmacodynamic and pharmacokinetic profiles that could improve safety, efficacy and tolerability and enable less frequent dosing. Share prices were likely down because of these factors.
Based on the study results, management is currently reviewing cost-reduction activities to extend its existing cash runway. It expects to initiate these activities before the end of this quarter.
Year to date, shares of Marinus have plunged 88.0% compared with the industry’s 10.0% fall.
Image Source: Zacks Investment Research
Alongside the interim analysis, management also announced preliminary figures for Ztalmy product revenues in first-quarter 2024. It expects to record between $7.4 and $7.6 million from the drug during the quarter. The company expects to close the first quarter with an unaudited cash and cash equivalents balance of $113.3 million.
Marinus is evaluating the oral formulation of ganaxolone in the late-stage TrustTSC study in patients with tuberous sclerosis complex (TSC). Management expects to complete enrolment in the study by mid-May and plans to report top-line data from the study before June 2024-end.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 32.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 20.2%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Ligand Pharmaceuticals’ earnings estimates per share for 2024 have increased from $4.42 to $4.56. During the same period, earnings estimates for 2025 have risen from $5.11 to $5.27. Year to date, shares of Ligand Pharmaceuticals have gained 11.7%.
Ligand Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters. On average, LGND’s four-quarter earnings surprise was 84.81%.
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Marinus (MRNS) Down 83% on Lead Drug Falling Short in Seizure Study
Shares of Marinus Pharmaceuticals (MRNS - Free Report) plummeted 83% on Monday after management provided an interim analysis of results from the pivotal phase III RAISE study evaluating lead drug ganaxolone in refractory status epilepticus (RSE).
The RAISE study, which evaluated an intravenous (IV) formulation of ganaxolone, did not meet the pre-defined ‘stopping’ criteria in RSE patients.
While an independent data monitoring committee (IDMC) recommended continuing the RAISE study, management has decided to stop enrolling patients in the study of approximately 100 patients.
A life-threatening condition, status epilepticus is marked by seizures that last longer than five minutes or more than one seizure within five minutes. Per management, the condition affects up to 150,000 patients every year in the United States alone. Patients with this condition who do not respond to first-line or second-line treatments are considered to have RSE.
An oral formulation of ganaxolone has been approved in the United States since 2022 to treat seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older. This version of ganaxolone is currently being marketed under the trade name Ztalmy.
Currently, ganaxolone is the sole marketed as well as the only pipeline drug in Marinus’ portfolio. The pipeline setback in RSE indication casts doubt on the IV formulation of the drug. Marinus expects to report topline data from the RAISE study later this summer, based on which it will determine whether to advance the development of the IV formulation of the drug.
The disappointing RAISE study results also cast doubt on Marinus’ second-generation ganaxolone formulation, which aims to provide improved pharmacodynamic and pharmacokinetic profiles that could improve safety, efficacy and tolerability and enable less frequent dosing. Share prices were likely down because of these factors.
Based on the study results, management is currently reviewing cost-reduction activities to extend its existing cash runway. It expects to initiate these activities before the end of this quarter.
Year to date, shares of Marinus have plunged 88.0% compared with the industry’s 10.0% fall.
Image Source: Zacks Investment Research
Alongside the interim analysis, management also announced preliminary figures for Ztalmy product revenues in first-quarter 2024. It expects to record between $7.4 and $7.6 million from the drug during the quarter. The company expects to close the first quarter with an unaudited cash and cash equivalents balance of $113.3 million.
Marinus is evaluating the oral formulation of ganaxolone in the late-stage TrustTSC study in patients with tuberous sclerosis complex (TSC). Management expects to complete enrolment in the study by mid-May and plans to report top-line data from the study before June 2024-end.
Marinus Pharmaceuticals, Inc. Price
Marinus Pharmaceuticals, Inc. price | Marinus Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Marinus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) ,each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 32.3%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 20.2%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Ligand Pharmaceuticals’ earnings estimates per share for 2024 have increased from $4.42 to $4.56. During the same period, earnings estimates for 2025 have risen from $5.11 to $5.27. Year to date, shares of Ligand Pharmaceuticals have gained 11.7%.
Ligand Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters. On average, LGND’s four-quarter earnings surprise was 84.81%.