RADNOR -
'Our commercial strategy and deep understanding of the epilepsy and rare disease space continues to drive increasing adoption of ZTALMY, establishing a strong foundation for the future of the franchise and positioning us to generate robust growth in the year ahead,' said
ZTALMY
Continued to execute
Continued growth in commercial patients with more than 165 patients active on therapy at the end of 2023
Full year 2024 projected
Pipeline Update
Status Epilepticus
Over 90% of the 82 patients required for an interim analysis are now enrolled in the Phase 3 RAISE trial of intravenous (IV) ganaxolone in refractory status epilepticus (RSE)
Continue to expect enrollment for the interim analysis to conclude in the first quarter of 2024 with topline data anticipated in the second quarter of 2024, assuming pre-defined stopping criteria for the interim analysis are met
To date, 26 patients with super refractory status epilepticus (SRSE) have been treated with IV ganaxolone under eINDs
Ganaxolone development in the RAISE trial is being funded in part by the
Over 70% of the 128 patients required in the global Phase 3 TrustTSC trial of oral ganaxolone are now enrolled with expected enrollment completion by the end of Q1 2024; total blinded discontinuation rates to date remain below 10%
Topline data anticipated in Q3 2024
Financial Update
Preliminary unaudited cash, cash equivalents, and short-term investments of
The preliminary fourth quarter and full-year 2023 net product revenue results and cash, cash equivalents, and short-term investments included in this release were calculated prior to the completion of an audit by the Company's independent registered public accounting firm and are therefore subject to adjustment.
About
Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders. The Company first introduced FDA-approved prescription medication ZTALMY (ganaxolone) oral suspension CV in the
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 commercialization and marketing plans for ZTALMY; our net product revenue guidance; the potential benefits ZTALMY will provide for physicians and patients; statements regarding our expected clinical development plans, enrollment in our clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; our expected data readouts; our expected cash runway; our expectations and beliefs regarding the FDA and EMA with respect to our product candidates; our financial projections; the potential safety and efficacy of ganaxolone, as well as its therapeutic potential in a number of indications and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future events.
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, unexpected market acceptance, payor coverage or future prescriptions and revenue generated by ZTALMY; unexpected actions by the FDA or other regulatory agencies with respect to our products; competitive conditions and unexpected adverse events or patient outcomes from being treated with ZTALMY, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company's cash and cash equivalents may not be sufficient to support our operating plan for as long as anticipated; our ability to comply with the
Contact:
Email: jdenike@marinuspharma.com
Email: mcameron@marinuspharma.com
(C) 2024 Electronic News Publishing, source