Marinus Pharmaceuticals

2024 was a challenging year for the biopharma industry, with companies like Bayer, Bristol Myers Squibb, and Johnson & Johnson cutting hundreds to thousands of jobs. Cassava Sciences announced layoffs of 10 employees, 33% of its workforce, following a failed Phase III trial for its Alzheimer's drug. CytomX Therapeutics cut 40% of its staff to focus on clinical programs. Velia, a San Diego biotech, is shutting down, affecting 47 employees. Regeneron's acquisition of Oxular led to layoffs, with no Oxular employees joining Regeneron. Javara, Ring Therapeutics, Outlook Therapeutics, Editas, Bavarian Nordic, BenevolentAI, Chroma Medicine and Nvelop Therapeutics, Cellectar Biosciences, Carisma Therapeutics, Belharra Therapeutics, National Resilience, AmplifyBio, Agenus, Alligator Bioscience, Idorsia Pharmaceuticals, Kronos Bio, Novartis, Recursion Therapeutics, Medigene, Alector, Bristol Myers Squibb, Sonata Therapeutics, 23andMe, Johnson & Johnson, Merck, Gilead Sciences, Adaptimmune, Sensei Biotherapeutics, Marinus Pharmaceuticals, Orna Therapeutics, Thermo Fisher Scientific, Charles River Laboratories, Aurinia Pharmaceuticals, Viracta Therapeutics, Astellas Gene Therapies, Sana Biotechnology, Sage Therapeutics, Compass Pathways, Spero Therapeutics, ICON, Pfizer, Takeda, SalioGen Therapeutics, Evonik, Medtronic, CareFusion Resources, Turnstone Biologics, Leo Pharma, Astellas Pharma, Prime Medicine, Kaléo, Stryker, Relay Therapeutics, ImmunityBio, Shattuck Labs, Inventprise, bluebird bio, Athira Pharma, AGC Biologics, Oncternal Therapeutics, Biosense Webster, Vesigen Therapeutics, Connect Biopharma, BioMarin, IN8bio, Edwards Lifesciences, DermTech, Repare Therapeutics, Genentech, Tome Biosciences, Aadi Bioscience, Lykos Therapeutics, Evotec, Galera Therapeutics, Grail, Ovid Therapeutics, Lexicon Pharmaceuticals, Acelyrin, Boundless Bio, FibroGen, Ajinomoto Bio-Pharma Services, AN2 Therapeutics, Entero Therapeutics, Precigen, Sumitomo Pharma America, uniQure, Vir Biotechnology, Arbutus Biopharma, HilleVax, and Bayer also announced significant layoffs, reflecting a tough year for the industry.

Immedica Pharma acquires Marinus Pharmaceuticals for $151m, enhancing its global rare disease market presence. The deal includes ZTALMY, a seizure treatment for CDKL5 deficiency disorder, aiming to boost Immedica's US revenue and expand globally. Expected to conclude by Q1 2025, the merger is approved by Marinus' board.

Immedica Pharma AB agreed to buy Marinus Pharmaceuticals for over $151M, boosting Marinus shares by 43%. The deal includes ZTALMY, a seizure medicine, enhancing Immedica's rare neurology portfolio and North American presence. The tender offer is $0.55 per share, a 48% premium. Expected to conclude in Q1 2025, the deal follows Marinus's strategic assessment to maximize shareholder value.

Marinus Pharmaceuticals laid off 45% of its employees after ganaxolone's Phase III failure in treating tuberous sclerosis complex seizures, reducing its workforce to about 73. The company is exploring strategic alternatives and plans to discuss a potential path forward for intravenous ganaxolone with the FDA.

Marinus Pharmaceuticals navigates recent clinical setbacks and financial challenges while focusing on oral ganaxolone's potential in TSC and other rare epilepsies. ZTALMY's revenue growth and the TrustTSC trial's outcome are crucial for the company's future, balancing debt obligations and market competition.

Sangamo Therapeutics' shares surged 69% after FDA alignment on an Accelerated Approval pathway for its Fabry disease gene therapy, isaralgagene civaparvovec (ST-920), using data from its Phase I/II STAAR trial. The company plans to submit a BLA in the second half of 2025, three years ahead of previous estimates.

Amgen sets $1,665 list price for biosimilar Eylea, launching Pavblu without legal settlement. GSK invests $800 million in U.S. manufacturing expansion. Roche partners with Dyno Therapeutics for neurological gene therapy. AbbVie and Gideon Richter collaborate on neuropsychiatric treatments. Marinus Pharmaceuticals faces strategic review after Phase 3 seizure drug trial failure.

Marinus Pharmaceuticals' Phase III TrustTSC trial of oral ganaxolone for TSC-associated seizures in children and adults failed to meet its primary endpoint, despite a 19.7% median reduction in seizure frequency. The company is halting further development and exploring strategic alternatives.

Marinus Pharmaceuticals' Phase 3 TrustTSC trial of oral ganaxolone for TSC-associated seizures failed to meet primary endpoint; 19.7% median reduction vs 10.2% for placebo (p=0.09). Company discontinues ganaxolone development, cuts costs, and explores strategic alternatives with Barclays. Continues support for ZTALMY®, FDA-approved for CDKL5 deficiency disorder, treating over 200 patients.

Ganaxolone showed significant seizure control in RSE patients, with 81% of placebo patients requiring further antiseizure meds vs. 55% in ganaxolone group. EEG data revealed a 93% seizure burden reduction in ganaxolone group compared to 36% in placebo. No FDA-approved RSE treatments exist; ganaxolone is the first safe and effective option in a randomized trial.