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PharmaTher Announces Path to Ketamine Commercialization with No Planned Financing, Confirms FDA Approval Goal Date of August 9th, 2025 for Ketamine
Globenewswire· 2025-07-02 12:00
Core Insights - PharmaTher Holdings Ltd. aims to become a global leader in ketamine-based pharmaceuticals, with a clear strategy for regulatory approval and international expansion [1][3] Regulatory Milestones - The FDA has set an approval goal date of August 9, 2025, which is a significant milestone for the company, potentially unlocking a multi-billion-dollar market opportunity [3][7] - The current global market for ketamine is valued at $750 million and is projected to grow at a CAGR of 16.4%, reaching approximately $3.42 billion by 2034 [3] Financial Position - The company is fully funded for all planned operations leading up to the FDA approval goal date and the initial U.S. commercial launch of its ketamine product [5][7] - PharmaTher has no plans for new equity or debt financing before the FDA approval date, indicating confidence in its current financial position [6][7] Commercial Strategy - The manufacturing of the ketamine product is based in the U.S., ensuring supply chain security and quality control [7][8] - PharmaTher is preparing for international regulatory submissions in Europe, the UK, Canada, Japan, and the APAC regions, expected to begin in the second half of 2025 [7][8] Expansion and Innovation - The company is exploring new therapeutic applications for ketamine, inspired by bipartisan support for psychedelic-assisted therapies [9] - PharmaTher aims to broaden its clinical pipeline, focusing on indications such as Parkinson's disease, ALS, and CRPS, as well as novel delivery systems [7][9] Leadership Vision - The CEO emphasizes the upcoming FDA approval goal date as a critical starting point for global expansion and new therapeutic indications [10]
PharmaTher Secures Key US Patent for Ketamine in Amyotrophic Lateral Sclerosis (ALS), Bolstering its Orphan Drug Designated Program and Targeting a Billion Dollar Market
Globenewswire· 2025-06-24 12:00
Core Viewpoint - PharmaTher Holdings Ltd. has received a U.S. patent for the use of ketamine in treating Amyotrophic Lateral Sclerosis (ALS), significantly enhancing its intellectual property portfolio and clinical development program [1][2][3] Company Overview - PharmaTher is focused on unlocking the pharmaceutical potential of ketamine, particularly for severe neurological disorders [1][3][8] - The company aims to address unmet medical needs in various fields, including surgery, pain, mental health, and neurological conditions [8] Patent and Regulatory Designations - The newly granted U.S. Patent No. 12,128,012, expiring on May 14, 2041, provides long-term protection for the specific method of using ketamine to treat ALS [7] - The company holds an Orphan Drug Designation (ODD) from the FDA, which offers seven years of market exclusivity post-approval, tax credits for clinical trials, exemption from FDA application fees, and regulatory guidance [7] Market Opportunity - The ALS treatment market is projected to exceed USD $1.04 billion by 2030, driven by high unmet needs and a dedicated patient advocacy community [7] - Approximately 5,000 new ALS cases are diagnosed annually in the U.S., with an estimated 30,000 individuals currently living with the disease [7] Strategic Positioning - The combination of the new patent and FDA ODD creates a strong strategic advantage for PharmaTher, allowing the company to advance its clinical program and pursue strategic partnerships [6][7] - The company is positioned to deliver potentially life-altering therapies to patients with urgent medical needs [6][3]
PEEK,汽车/人形机器人两大应用突破
DT新材料· 2025-06-22 13:19
在结构设计上 ,通过高分子复合材料轴承与弹性中空滚柱一体化架构,进一步优化了体积与寿命表现。与传统金属谐波减速器相比,该产品轴向尺寸缩 减20%、重量降低40%,全面满足人形机器人对于紧凑与轻量化的双重要求。 这一突破在行业内引发了强烈关注。 PEEK复合材料的密度仅为铝的一半,而单位重量下的强度却是铝的5至7倍 ,使这款减速器在轻量与强度之间达成了优异的平衡。未来几年,以 PEEK、碳纤维树脂为代表的高性能复合材料,将逐步取代传统金属轴承。当前PEEK价格较高,主要受限于规模化出货。 一旦人形机器人进入量产, 前沿产品验证材料价值后,成本势必快速下探,正如当年的新能源行业所经历的路径一样。 作为特种工程塑料中最受关注的品种,PEEK近期迎来两大应用新突破。 【DT新材料】 获悉, 6月10日,先进材料和特种化学品领域的领先企业 世索科 (Syensqo)宣布,其创新的 Ajedium™ PEEK(聚醚醚酮)绝缘槽 衬和槽楔,以及 KetaSpire® PEEK 电磁线绝缘材料, 被 马威电动力(Mavel) 选中,用于集成到其为一家知名高端跑车制造商开发的最新高压电机 中 。 Ajedium™ PEEK 绝 ...
PharmaTher Applauds FDA's New Commissioner’s National Priority Voucher (CNPV) Program, Citing Potential to Accelerate its Ketamine Programs for Mental Health, Pain, and Neurological Disorders, and National Security Applications
Globenewswire· 2025-06-18 12:00
Core Insights - PharmaTher Holdings Ltd. is focused on developing ketamine-based therapies and supports the FDA's new Commissioner's National Priority Voucher (CNPV) program to expedite the regulatory review process for its products [1][2][7] - The CNPV program significantly reduces the review time for drug applications from approximately 10-12 months to 1-2 months, allowing for accelerated approval if legal requirements are met [2] - PharmaTher has a robust chemistry, manufacturing, and controls (CMC) package for its ketamine product, with an FDA approval goal date set for August 9, 2025 [3] Clinical Developments - The company has promising clinical data for its ketamine therapies targeting rare and near-rare disorders, including Parkinson's disease and Complex Regional Pain Syndrome [4] - PharmaTher is developing innovative delivery systems such as KETAPATCH™, a microneedle patch, and a wearable pump, which aim to provide easier administration compared to traditional intravenous infusions [4] Regulatory Designations - The FDA has granted five orphan drug designations to PharmaTher for ketamine treatments addressing conditions like Amyotrophic Lateral Sclerosis (ALS) and Rett Syndrome [5] - These designations highlight the company's commitment to addressing critical unmet medical needs, particularly in mental health and pain management [6] Strategic Positioning - PharmaTher aims to leverage the CNPV program to enhance its development timeline and deliver value to patients and shareholders, aligning with national health priorities [7] - The company is positioned to become a leader in the pharmaceutical development of ketamine through its focus on novel, intellectual property-protected delivery systems [7]
NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners
Prnewswire· 2025-06-16 12:03
Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics have formed a strategic investor relations partnership with astr partners to enhance their visibility and investor engagement at a critical juncture in their development [1][2][3] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is advancing NRX-101, which has received FDA designation as an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression, and plans to file for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine, and is also pursuing a New Drug Application for the treatment of suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a wholly-owned subsidiary of NRx Pharmaceuticals, focused on building a network of interventional psychiatry clinics that provide ketamine and transcranial magnetic stimulation (TMS) therapies [6] - The company aims to offer lifesaving therapies for patients with suicidal depression and related disorders, supported by a digital therapeutic-enabled platform [6] Strategic Partnership - The partnership with astr partners is expected to leverage their extensive experience in biotech investor relations and relationships with specialist investors to enhance NRx and HOPE's market presence [2][3] - The investor relations program will include investor targeting, message development, earnings preparation, conference support, and proactive engagement [3]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) and HOPE Therapeutics, Inc. to Present at H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference
Prnewswire· 2025-06-12 12:03
Core Insights - NRx Pharmaceuticals and its subsidiary HOPE Therapeutics will participate in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference on June 16-17, 2025 [1][2] - Dr. Jonathan Javitt, CEO of NRx and Co-CEO of HOPE, will present the company's latest advancements, available on demand for registered attendees starting at 7:00 a.m. ET on June 16, 2025 [2][8] - The company will also engage in one-on-one meetings with investors during the conference [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal bipolar depression, chronic pain, and PTSD [4] - The company is advancing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain, with plans to file an NDA for Accelerated Approval [4] - NRx has filed an Abbreviated New Drug Application for NRX-100, a preservative-free IV ketamine, and is pursuing a New Drug Application for its use in treating suicidal depression [5] HOPE Therapeutics Overview - HOPE Therapeutics is a subsidiary of NRx Pharmaceuticals, focused on creating a network of interventional psychiatry clinics offering ketamine and other therapies for suicidal depression [6] - The company aims to enhance clinical benefits through a digital therapeutic-enabled platform that complements NMDA-targeted drug therapy [6]
Neuronetics Announces Clinical Presence at the 2025 Clinical TMS Society Annual Meeting and Progress in Greenbrook's Personalized Care Trial Program
Globenewswire· 2025-06-10 12:31
Core Insights - NeuroStar, a Silver Sponsor at the 13th Annual Clinical TMS Society (CTMSS) Meeting, is committed to clinical innovation and excellence in mental health care [1][2] - The company will present two significant poster presentations based on the TrakStar data set, which is the largest real-world outcomes database in TMS [2][3] - NeuroStar aims to optimize TMS efficacy and expand its use into new populations and protocols, reinforcing its leadership in the psychiatric community [3] Company Updates - NeuroStar will present a retrospective analysis comparing clinical outcomes between its proprietary Figure-8 coil and Brainsway's H-coil in treating depression [2] - The company is evaluating personalized qEEG-informed protocols for TMS therapy, demonstrating operational feasibility with the NeuroStar TMS System [4] - NeuroStar has delivered over 7.4 million treatments and operates Greenbrook TMS centers across the U.S. for treating Major Depressive Disorder (MDD) and other mental health disorders [6] Event Participation - The CTMSS Meeting will take place from June 11-14 in San Diego, CA, where NeuroStar will also participate in the PULSES Course for TMS providers [2] - Presentations will include data on elderly adults (age 70 and older) with MDD treated with TMS, and a retrospective analysis from 200 Greenbrook centers [7]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine
Prnewswire· 2025-06-05 12:03
Core Insights - NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) for NRX-100, a preservative-free IV ketamine formulation, to the FDA for use in approved indications such as anesthesia and pain management [1][2] Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6] - An estimated 5.1 million Americans have received ketamine for medical uses, with demand continuing to rise due to increased clinical focus [2][6] - There is a severe drug shortage of ketamine in the U.S., which is not expected to improve in the near future [6] Company Developments - NRx Pharmaceuticals aims to capture a significant share of the existing ketamine market with its NRX-100 formulation, which eliminates the neurotoxic preservative benzethonium chloride [3][5] - The company plans to file a citizen's petition with the FDA to remove benzethonium chloride from all intravenous ketamine presentations [3][6] - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients to support the extension of ketamine's labeled indications to include treatment for suicidal depression [4][8] Regulatory and Patent Status - The FDA has granted a waiver of the $4.3 million NDA fee for NRX-100, recognizing its public health value [5] - NRX-100 has received Fast Track Designation from the FDA, and the company has filed a patent for this novel formulation, seeking protection until 2045 [5][8]
国泰海通互联网应用2025年中期策略:消费周期与AI叙事下的中国互联网投资新范式
智通财经网· 2025-06-04 03:45
Core Viewpoint - The report from Guotai Junan expresses optimism for the Hang Seng Technology Index in the second half of the year, driven by domestic policy support and improving capital conditions in Hong Kong, despite uncertainties in US-China trade negotiations [1] Summary by Sections Investment Recommendations - The report recommends focusing on two main lines of investment: 1. Alibaba-W (09988) and Kuaishou-W (01024) due to their upward trends in fundamentals and benefits from AI-related products [2] 2. Meituan-W (03690), Pinduoduo (PDD.US), and JD Group-SW (09618) for their solid long-term business models and expansion into new growth areas [3] Company-Specific Insights - **Alibaba-W**: Anticipated continued growth in its cloud business and e-commerce, with a projected 12% year-on-year increase in CMR for Q4 FY25 [2] - **Kuaishou-W**: Expected improvement in e-commerce business due to strategic adjustments by Douyin, with significant potential from the updated Keta 2.0 version [2] - **Meituan-W**: Short-term investments are aimed at solidifying market share, with long-term competitive advantages expected to be maintained through network effects in the food delivery sector [3] - **Pinduoduo**: Focus on ecosystem development may pressure short-term profits, but long-term prospects remain strong with anticipated recovery in profitability in the second half of the year [3] - **JD Group-SW**: Q1 FY25 revenue exceeded expectations, driven by user growth and strong performance in the food delivery segment [3]
Neuronetics Set to Join Russell 2000® and Russell 3000® Indexes
GlobeNewswire News Room· 2025-06-02 20:30
Company Overview - Neuronetics, Inc. is a commercial stage medical technology and healthcare company focused on transforming patient lives through neurohealth therapies [1] - The company operates the NeuroStar Advanced Therapy System, a non-drug, noninvasive treatment for major depressive disorder (MDD) and other neurohealth conditions [5][6] Market Position - Neuronetics is set to join the Russell 3000® Index and the Russell 2000® Index effective June 30, 2025, which is a significant milestone for the company [1][4] - The Russell indexes are widely utilized by investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them [2] Strategic Vision - The inclusion in the Russell indexes validates Neuronetics' strategic vision and operational execution, enhancing visibility among institutional investors [4] - The company aims to expand access to innovative mental health treatments through an integrated approach, combining NeuroStar technology with a growing clinic network [4] Treatment Impact - NeuroStar Advanced Therapy has delivered over 7.4 million treatments and is backed by the largest clinical data set for TMS treatment for depression [5] - Greenbrook treatment centers have provided more than 1.8 million treatments to over 55,000 patients suffering from depression [5]