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]

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]

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]

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]

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]

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]

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]

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]

Term sheet with Universal Capital, LLC to fund HOPE Therapeutics clinic acquisition strategy Funding tied to already-announced acquisitions, with additional tranches contemplated for further growth, subject to standard due diligence Together with previously announced term sheet with a strategic investor, HOPE funding of $10.3 million is planned in the near term  MIAMI, May 15, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a multi-site clinical care delivery organization and wholly-owned subsidiar ...

Kadima Neuropsychiatry Institute in La Jolla, CA expected to serve as clinical model for Hope treatment offerings nationwide Kadima is a leading investigative site for CNS and psychedelic research, having served as the lead site in nearly all major trials in this space Dr. David Feifel, a nationally recognized pioneer in interventional psychiatry to join HOPE as Chief Medical Innovation Officer upon closing Acquisition expected to be accretive to revenue and EBITDA for NRx and HOPE MIAMI, May 13, 2025 /PR ...