Esketamine Hydrochloride

Policy update increases access for millions covered by Evernorth Health ServicesMALVERN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a vertically integrated, commercial stage, medical technology and healthcare company with a strategic vision of transforming the lives of patients whenever and wherever they need help, with the leading neurohealth therapies in the world, announced that Evernorth Health Services, a wholly owned subsidiary of The Cigna Group, has expanded its coverage of NeuroStar® Transcranial Magnetic Stimulation (TMS) to include adolescents aged 15 and older living with major depressive disorder (MDD). As these health policies cover 15 million lives, the expansion greatly improves access to non-drug treatment options for adolescent patients who are seeking non-drug options for depression. The expansion is effective immediately, nearly one year after NeuroStar® Advanced Therapy received FDA clearance as the first first-line add-on treatment for adolescents aged 15-21 with MDD. In the past year, several leading insurers have rapidly updated their policies to reflect the FDA clearance, including but not limited to Humana, Aetna, Medi-Cal, BCBS-HCSC, Pacific Source, and more. “This decision by Cigna/Evernorth is a significant step forward for adolescent mental healthcare and reflects the momentum we have built with payors over the past year since NeuroStar first received the FDA clearance for adolescents,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are grateful that millions more families will now have easier access to NeuroStar TMS as a proven, non-drug treatment for major depression and can get the care they deserve.” An estimated 4.3 million U.S. adolescents aged 15-21 are affected by major depression1. Depression amongst adolescents can disrupt crucial aspects of development, such as academic performance, relationships with peers and family members, and overall emotional well-being. With limited medication options for adolescents with MDD, NeuroStar is a safe and effective option that can be used as a first-line add-on with robust clinical outcomes. “NeuroStar stands as the leading TMS device, backed by the most comprehensive data that clearly demonstrates its effectiveness in treating adolescent major depressive disorder,” said Geoffrey Grammer, MD, Chief Medical Officer of Neuronetics. “At Neuronetics, we are deeply committed to putting patients first, advancing clinical research, and ensuring that those in need have access to life-changing, innovative solutions.” Neuronetics is the only TMS company in the industry with a dedicated health policy team that partners with both providers and payors to advocate for health policy updates. For more information about NeuroStar Advanced Therapy, please visit www.neurostar.com. About Neuronetics Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is delivering more treatment options to patients and physicians by offering exceptional in-office treatments that produce extraordinary results. NeuroStar Advanced Therapy is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, Neuronetics operates Greenbrook TMS Inc. (Greenbrook) treatment centers across the United States, offering NeuroStar Advanced Therapy for the treatment of MDD and other mental health disorders. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults, with more than 7.1 million treatments delivered, and is backed by the largest clinical data set of any TMS treatment system for depression, including the world’s largest depression outcomes database. Greenbrook treatment centers also offer SPRAVATO® (esketamine) Nasal Spray, a prescription medicine indicated for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. It is also indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.1 Greenbrook has provided more than 1.68 million treatments to over 51,000 patients struggling with depression. The NeuroStar Advanced Therapy System is cleared by the U.S. Food and Drug Administration for adults with MDD, as an adjunct for adults with obsessive-compulsive disorder, to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression), and as a first line adjunct for the treatment of MDD in adolescent patients aged 15-21. For safety information and indications for use, visit NeuroStar.com. Neuronetics Contact:Investors:Mike Vallie or Mark KlausnerICR Healthcare443-213-0499ir@neuronetics.com Media:EvolveMKD646.517.4220NeuroStar@evolvemkd.com References World Health Organization, Depression Fact Sheet. Accessed April 29, 2024. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/depression. ________________________________* The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. For more important safety information about SPRAVATO®, please visit spravatohcp.com.

The FDA on Wednesday approved Soleno Therapeutics’ new drug designed to treat the worst symptom of a debilitating rare disease known as Prader-Willi syndrome. Regulators approved diazoxide choline (often shortened to DCCR) to treat insatiable hunger, or hyperphagia, felt by patients with Prader-Willi syndrome, a rare disease caused by spontaneous genetic mutations. The drug will be branded as Vykat XR and will cost an average of $466,200 per year, Soleno executives said late Wednesday. Soleno expects the drug to be available as soon as next month, according to an SEC document . Patients with Prader-Willi syndrome are typically diagnosed at birth because they are born “floppy,” with little muscle tone, CEO Anish Bhatnagar told Endpoints News ahead of the FDA’s decision. But their hyperphagia symptoms typically manifest when a patient is between 8 and 12 years old. Some may exhibit hyperphagia as early as four years. “When these babies are born, they are born with very low muscle tone, and so they’re called floppy babies,” Bhatnagar said. “You pick up the baby in the palm of your hand, and they would drape over on both sides. So it’s very obvious to the doctor at the time that something is wrong.” The disease is caused by random mutations of chromosome 15 and occurs in roughly one of every 15,000 live births globally. It’s not an inherited disease, so the prevalence is consistent across different geographies and ethnicities. In Western countries, “virtually all” of these babies end up in the NICU, Bhatnagar said. There are no other approved treatments for patients with Prader-Willi syndrome. Patients with Prader-Willi syndrome have a wide range of symptoms beyond hyperphagia, including delayed motor skills, not making enough growth hormone and speech and behavioral problems. But hyperphagia remains the most difficult for patients and their families. Divorce rates among parents of children with Prader-Willi syndrome are higher than normal, and unaffected siblings sometimes have PTSD from patients’ sometimes aggressive food-seeking behaviors. Families have to lock access to all food and trash cans in the house, Bhatnagar said. Patients may end up living in group homes for those with Prader-Willi syndrome if their families can afford it. Other times, they know their hyperphagia is a problem but can’t do anything about it. The behavioral problems often lead to mental health challenges and prescriptions for antidepressants, but those don’t tend to help. “As rare diseases go, this is one of those problems which is truly intractable,” the CEO said. Vykat XR doesn’t treat the underlying genetic cause of the disease. But by going after the intense desire to eat, Soleno hopes patients and families can alleviate the condition’s biggest burden. It works by targeting KATP, or the ATP-dependent potassium channel, and a hunger mechanism in the hypothalamus to reduce appetite. Vykat XR is a once-daily pill. Soleno intends to commercialize Vykat XR on its own in the US, though it may seek a partner to commercialize the drug elsewhere, Bhatnagar said. Soleno had $318 million in cash and cash equivalents at the end of 2024, and Bhatnagar said the company is “well-positioned” to launch Vykat XR. Some analysts think the drug could become a blockbuster. Stifel’s Paul Matteis wrote earlier this month that Vykat XR could reach at least $1.5 billion in annual peak sales despite the drug failing its primary endpoint in Phase 3 due to a pandemic-related high placebo response. But the FDA has opted to exercise more flexibility in rare disease approvals, Matteis added, and a randomized withdrawal study after the Phase 3 was highly statistically significant. Johnson & Johnson’s Spravato — a depression treatment — was approved in January using a similar trial framework. “We believe there’s potential upside here, as well,” Matteis wrote. Editor’s note: This article has been updated with Vykat XR’s average annual price.