Latest news with #ZURZUVAE
Globe and Mail
21 hours ago
- Health
- Globe and Mail
Postpartum Depression Treatment Market Size in the 7MM was estimated to be USD 260 million in 2023, and is expected to increase a significant CAGR by 2034, estimates DelveInsight
DelveInsight's 'Postpartum Depression Treatment Market Insights, Epidemiology, and Market Forecast – 2034' report delivers an in-depth understanding of all Postpartum Depression types, historical and forecasted epidemiology as well as the Postpartum Depression market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan. Discover which therapies are expected to grab the Postpartum Depression Market Share @ Postpartum Depression Market Outlook Key Takeaways from the Postpartum Depression Market Report In May 2025, Nanjing Minova Pharmaceutical Co., Ltd. announced a study is a multicenter, randomized, double-blind, placebo-controlled trial. It includes three groups. Each group will enroll 24 participants. The trial aims todetermine： To evaluate the efficacy of MI078 capsules in treating postpartum depression and to explore the optimal dosing regimen for MI078 capsules. In May 2025, Reunion Neuroscience Inc. announced a study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. In the seven major Postpartum Depression Therapeutics Market, SNRI's and SSRI's constituted 20% market share of the overall Postpartum Depression Drugs Market, while Atypical antidepressants and Antipsychotics held 19% market share, in 2023. In the 7MM, ZURZUVAE is expected to garner Postpartum Depression Therapeutics market revenue of ~USD 600 million by 2034. Among the seven major market, the United States held the highest Postpartum Depression Drugs Market Share (64%) of the overall Postpartum Depression market. Among EU4 and the UK, the UK accounted for the highest Postpartum Depression Treatment Market Size was ~USD 25 million in 2023 Japan accounted for a Postpartum Depression Market Size of ~USD 20 million in 2023, which is expected to increase at a moderate rate by 2034. The leading Postpartum Depression Companies such as Sage Therapeutics, Biogen, Marinus Pharmaceuticals, Lipocine, Brii Biosciences Limited and others. Promising Postpartum Depression Pipeline Therapies such as SAGE-217, Brexanolone, Aripiprazole, Escitalopram, ZULRESSO®, BRII-296, Ganaxolone, Sertraline and others. Stay ahead in the Postpartum Depression Therapeutics Market with DelveInsight's Strategic Report @ Postpartum Depression Treatment Market Postpartum Depression Epidemiology Total Diagnosed Prevalent Population of Maternal Postpartum Depression Download the report to understand which factors are driving Postpartum Depression Epidemiology trends @ Postpartum Depression Prevalence Postpartum Depression Marketed Therapies ZURZUVAE (zuranolone) : Sage Therapeutics/Biogen Zuranolone (SAGE-217) is an investigational, oral, novel medicine in development for postpartum depression (PPD). It is given once daily, a 2-week therapy neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM) specifically designed to relieve several depression disorders, including PPD, major depressive disorder (MDD), and treatment-resistant depression. The GABA system is the major inhibitory signaling pathway of the brain, and the central nervous system (CNS) significantly regulates CNS function. SAGE-217 has been optimized for selectivity to synaptic and extrasynaptic type a γ-aminobutyric acid (GABAA) receptors and a pharmacokinetic profile for daily oral dosing. ZULRESSO: Sage Therapeutics ZULRESSO is a proprietary IV formulation of brexanolone. Brexanolone is chemically identical to allopregnanolone, a naturally occurring neuroactive steroid that acts as a positive allosteric modulator of gamma-aminobutyric acid (GABA) receptors indicated for treating PPD in adults. Brexanolone is available to patients only through a Risk Evaluation and Mitigation Strategy (REMS) program and must be administered at a certified healthcare facility. In addition, patients must be monitored continuously during the drug infusion due to the risk of serious side effects. Notably, ZULRESSO (brexanolone) is the first drug approved by the US FDA specifically for PPD in adults. Postpartum Depression Emerging Therapies Ganaxolone: Marinus Pharmaceuticals Ganaxolone (CCD-1042) is a lead clinical-stage drug candidate that brings a GABAA receptor modulating mechanism and an extensive safety database with exhibited anti-epileptic (antiseizure), anxiolytic (anti-anxiety) and anti-depressive activity in development by Marinus Pharmaceuticals. It is being developed in three different dosage forms (IV, capsule, and liquid) to maximize therapeutic reach to adult and pediatric patients in acute and chronic care settings with severe PPD. Unlike benzodiazepines, ganaxolone exhibits antiseizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been designed with an added methyl group that prevents back conversion to an active steroid, which unlocks ganaxolone's potential for chronic use. In preclinical studies, ganaxolone exhibited potency and efficacy comparable to allopregnanolone. To learn more about Postpartum Depression Treatment guidelines, visit @ Postpartum Depression Clinical Trials Assessment Postpartum Depression Market Outlook Antidepressants, such as Abilify (aripiprazole), Zoloft (sertraline hydrochloride), Spravato (esketamine), Prozac (fluoxetine capsules), Celexa (citalopram hydrobromide), Luvox CR (Fluvoxamine Maleate), and Paxil CR (paroxetine) form the mainstay in the Postpartum Depression treatment. Although these drugs are approved for treating depression-related disorders such as major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), etc., they are being used as off-label drugs for the treatment of PPD. The type of medication prescribed by the doctors largely depends on the set of symptoms, severity and the specific type of PPD the patient is suffering from. The primary concern about antidepressants is the uncertainty in the outcomes and their side effects on new born due to breastfeeding. Though antidepressants are not necessarily a permanent cure for PPD, they are an important aspect of managing depression symptoms and restoring quality of life. Postpartum Depression Treatment Landscape Antidepressant medications, cognitive-behavioral therapy (CBT), and interpersonal therapy are effective in treating Postpartum Depression. Other Postpartum Depression treatments which may be useful include psychodynamic therapy, light therapy, exercise, and yoga, but the current research evidence about the efficacy of such treatment regimens is more preliminary. Scope of the Postpartum Depression Market Report Coverage- 7MM Study Period- 2020-2034 Postpartum Depression Companies- Sage Therapeutics, Biogen, Marinus Pharmaceuticals, Lipocine, Brii Biosciences Limited and others. Postpartum Depression Pipeline Therapies- SAGE-217, Brexanolone, Aripiprazole, Escitalopram, ZULRESSO®, BRII-296, Ganaxolone, Sertraline and others. Postpartum Depression Market Dynamics: Postpartum Depression Market Drivers and Barriers Postpartum Depression Market Access and Reimbursement, Unmet Needs and Future Perspectives Table of Content 1. Key Insights 2. Report Introduction 3. Postpartum Depression Market Overview at a Glance 4 Executive Summary of Postpartum Depression 5 Key events 6 Disease Background and Overview 7 Treatment and Management 8 Methodology 9 Epidemiology and Patient Population 10 Patient Journey 11 Marketed Therapies 12 Emerging Therapies 13 Postpartum Depression (PPD): Seven Major Market Analysis 14 KOL Views 15 SWOT Analysis 16 Unmet Needs 17 Market Access and Reimbursement 18 Appendix 19 DelveInsight Capabilities 20 Disclaimer 21 About DelveInsight About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
12-02-2025
- Business
- Yahoo
Sage Therapeutics Inc (SAGE) Q4 2024 Earnings Call Highlights: Strong Prescription Growth Amid ...
Revenue: $11.4 million in Q4 2024, a 4% increase from Q3 2024; $36.1 million for the full year 2024. R&D Expenses: $37 million in Q4 2024. SG&A Expenses: $54 million in Q4 2024. Restructuring Expenses: One-time expenses of $22.5 million in Q4 2024. Net Loss: $95.8 million for Q4 2024. Cash Position: $504 million in cash, cash equivalents, and marketable securities as of December 31, 2024. Prescription Growth: 2,500 prescriptions shipped in Q4 2024, a 21% increase from Q3 2024; over 6,600 prescriptions for the full year 2024. Coverage: Greater than 95% of commercial and Medicaid lives covered or with a path to coverage for ZURZUVAE. Warning! GuruFocus has detected 4 Warning Signs with SAGE. Release Date: February 11, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Sage Therapeutics Inc (NASDAQ:SAGE) reported early commercial success with ZURZUVAE, the first oral treatment for postpartum depression (PPD), exceeding expectations with over 6,600 shipments in 2024. The company plans to invest in 2025 to fuel top-line revenue growth, indicating confidence in ZURZUVAE's market potential. ZURZUVAE has achieved greater than 90% aided brand awareness among OB-GYNs and psychiatrists, reflecting strong market penetration. More than 95% of commercial and Medicaid lives are covered or have a path to coverage for ZURZUVAE, ensuring broad access for patients. Sage Therapeutics Inc (NASDAQ:SAGE) has a strong financial position with cash runway expected to last until mid-2027, supporting ongoing operations and strategic initiatives. The company reported a net loss of $95.8 million for the fourth quarter of 2024, highlighting ongoing financial challenges. There were one-time restructuring expenses of $22.5 million in the fourth quarter of 2024, impacting overall financial performance. Despite strong demand growth, revenue growth was modest due to inventory dynamics, indicating potential challenges in supply chain management. The company is facing strategic uncertainty with Biogen's unsolicited acquisition proposal and the initiation of a strategic review process. Sage Therapeutics Inc (NASDAQ:SAGE) is not currently investing in further development of SAGE-324, indicating potential limitations in pipeline advancement. Q: Can you elaborate on Biogen's involvement in the sales force expansion and marketing efforts for ZURZUVAE? A: Barry Greene, CEO, explained that based on 2024's performance, Sage and Biogen have aligned on an integrated commercialization plan for 2025. This includes increasing the sales force and investing in medical affairs, disease state awareness, and direct-to-consumer (DTC) efforts. Chris Benecchi, COO, added that social media campaigns and connected TV are part of the strategy to reach both patients and healthcare providers. Q: Could you explain the inventory dynamics and the proportion of free drugs provided in Q4? A: Barry Greene noted that demand grew over 20% quarter-on-quarter, and Chris Benecchi clarified that revenue is recorded when product moves to wholesalers, with inventory fluctuations at specialty pharmacies and wholesalers. The percentage of free drugs decreased in Q4, and they expect this trend to continue as coverage improves. Q: How are you addressing potential headwinds in Q1 due to payer dynamics? A: Barry Greene stated they anticipate continued growth in Q1, as their reimbursement is primarily through commercial and Medicaid channels, avoiding typical Medicare-related issues. Chris Benecchi added that the market is promotionally responsive, and they do not expect holiday-related disruptions in Q1. Q: Can you provide more details on the sales force expansion and its expected impact? A: Barry Greene mentioned that the sales force was expanded in Q4, resulting in a 33% increase in territories where they expanded. Although specific future guidance wasn't provided, they are confident that the expansion will continue to drive demand and revenue growth. Q: Are there any constraints on commercial support for ZURZUVAE following the corporate restructure? A: Barry Greene assured that there are no constraints on commercial support. They are focused on scaling with success and believe that investments will lead to immediate improvements in demand and revenue. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
