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PharmaTher Applauds FDA's Commissioner's National Priority Voucher (CNPV) Selection of Ketamine; Company Highlights Potential Ketamine Opportunity, 505(b)(2) Focus, and Upside from Strategic ANDA Sale
Newsfile· 2025-10-17 12:26
Core Insights - The FDA's selection of ketamine for the Commissioner's National Priority Voucher (CNPV) program elevates its status as a national priority, potentially increasing demand for domestic ketamine supply [1][2][3] - PharmaTher is strategically positioned to benefit from this development through its capital-light 505(b)(2) strategy and the sale of its Abbreviated New Drug Application (ANDA) [3][4][7] Market Implications - The CNPV is expected to catalyze the ketamine market, signaling to hospitals and public buyers the importance of reliable U.S. sources, which may amplify demand [2][3] - The program's expedited review process (1-2 months) is designed to reduce regulatory friction, facilitating quicker market entry for ketamine products [2][10] Strategic Highlights for PharmaTher - The ANDA sale allows PharmaTher to participate economically in the ketamine market without significant capital expenditure, with potential payment milestones of up to US$25 million [3][4] - The company retains rights to non-generic applications of ketamine, including new indications and formulations, while the ANDA sale focuses solely on generic sales [3][4] Partner Engagement - The CNPV's focus on domestic supply strengthens PharmaTher's case for collaboration with U.S.-based manufacturers and commercial organizations for novel ketamine products [4][5] - Active discussions are ongoing for partnerships aimed at developing differentiated ketamine programs under the 505(b)(2) pathway [4][5] Digital Health Integration - The elevation of ketamine under CNPV is expected to enhance data and partnership activities, driving growth in PharmaTher's Digital Health AI division, which includes KetaVault™ and KetAImine™ [5][6] Development Pipeline - PharmaTher is preparing a Pre-Phase 3 FDA package for LID-Parkinson's disease, with a projected U.S. market opportunity of approximately US$0.75-$2.2 billion [6][7] - The company's approach aligns with FDA guidance on Real-World Evidence, which supports the use of high-quality data to complement clinical packages for new indications [10]
X @Ansem
Ansem 🧸💸· 2025-10-03 21:56
RT Gwart (@GwartyGwart)Even after I explained that the tech is broken, my ketamine dealer asked me to pay him in monero. I went ahead and called the cops on him. We don’t need these types of criminals on the streets. You either use my bags to do crime or you go to jail ...
'Ketamine Queen' pleads guilty in Matthew Perry's overdose death
NBC News· 2025-09-03 21:18
A Los Angeles drug dealer known as the so-called ketamine queen has pleaded guilty to charges in connection with the death of actor Matthew Perry. 42-year-old Jezine Sanghai was charged with supplying the drugs that killed the friend star back in 2023. She is the fifth and final defendant in the case to plead guilty and remains in custody. ...
'Ketamine Queen' pleads guilty over Matthew Perry's death
NBC News· 2025-09-03 20:06
Los Angeles drug dealer known as the so-called ketamine queen has pleaded guilty to charges in connection with the death of actor Matthew Perry. 42-year-old Jasine Sanga Sangha I should say was charged with supplying the drugs that killed the friend star back in 2023. She is the fifth and final defendant in the case to plead guilty and remains in custody.Joining us now NBC News entertainment correspondent Khloe Malas. So Khloe Sanggha previously pleaded not guilty in this case. So, walk us through what exac ...
NRx Pharmaceuticals (NASDAQ:NRXP) to Participate in a Fireside Chat at H.C. Wainwright's 27th Annual Global Investment Conference on Monday, September 8th
Globenewswire· 2025-09-03 12:03
Company Overview - NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [4] - The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression and NRX-101 receiving Breakthrough Therapy Designation for suicidal bipolar depression [4] - NRx Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100, applying for the Commissioner's National Priority Voucher Program for suicidal depression treatment [4] HOPE Therapeutics - HOPE Therapeutics, Inc. is a subsidiary of NRx Pharmaceuticals, aiming to establish a network of interventional psychiatry clinics offering ketamine, transcranial magnetic stimulation (TMS), and other therapies for patients with suicidal depression [5] - The company plans to integrate a digital therapeutic-enabled platform to enhance the clinical benefits of NMDA-targeted drug therapy [5] Upcoming Events - Jonathan Javitt, M.D., M.P.H., Chairman and CEO of NRx Pharmaceuticals, will participate in a fireside chat at H.C. Wainwright's 27th Annual Global Investment Conference on September 8, 2025, from 4:30 to 5:00 PM ET [1] - A webcast of the fireside chat will be available on the company's website, with a replay accessible for 30 days post-event [2] - Management will also engage in one-on-one investor meetings during the conference, with interested investors encouraged to contact their H.C. Wainwright representative or Brian Korb at astr Partners [3]
'Ketamine Queen' to plead guilty in Matthew Perry case
NBC News· 2025-08-19 01:09
Prosecutors say the woman who allegedly sold the ketamine that killed actor Matthew Perry will plead guilty. Her name is Jasmine Suna, known as the ketamine queen. She could face up to 65 years behind bars in connection with Perry's overdose death.She was scheduled to go on trial next month. Perry was found in a hot tub at his LA home back in 2023. The medical examiner there saying that he died of the acute effects of ketamine, a powerful anesthetic that has become more popular as a therapy for depression, ...
'Ketamine Queen' to plead guilty in Matthew Perry case
NBC News· 2025-08-18 22:38
Legal & Regulatory - Jasmine Sunga, dubbed the "ketamine queen," is expected to plead guilty in connection to Matthew Perry's death [1] - Sunga potentially faced a maximum sentence of 65 years, but the plea deal will likely result in a significantly reduced sentence [5] - The Department of Justice (DOJ) has agreed to drop several charges as part of the plea agreement [5] - Five individuals were charged in connection to Perry's death, all of whom have accepted plea deals [4][9] - Sentencing for those involved is expected to begin in the fall [10] Substance & Impact - Matthew Perry's death was attributed to the acute effects of ketamine [2] - Ketamine is described as a powerful anesthetic increasingly used as a therapy for depression, but also used recreationally [2] - Evidence against Sunga included incriminating text messages indicating attempts to cover up connections to Perry [7] - One individual, Kennethy Wamasa, Matthew Perry's assistant, administered the ketamine to Perry on the day of his death [9] - Dr Salvador Placencia, a doctor involved, can no longer practice medicine [10]
PharmaTher Announces FDA Approval of Ketamine (KETARx(TM))
Newsfile· 2025-08-11 13:49
Core Viewpoint - PharmaTher Holdings Ltd. has received FDA approval for its ketamine product KETARx™, marking a significant milestone in the company's efforts to become a leader in ketamine-based pharmaceuticals and contributing to the psychedelic pharmaceutical revolution [1][2]. Company Summary - The FDA approved KETARx™ on August 8, 2025, for surgical pain management, which positions PharmaTher strategically in the market [1]. - The company aims to leverage this approval to expand its product pipeline into various therapeutic areas, including mental health, neurological disorders, and chronic pain management [3]. - CEO Fabio Chianelli emphasized that this approval is a testament to years of development and signals a new era of growth for PharmaTher [2]. Industry Summary - Ketamine is the only psychedelic drug listed on the World Health Organization's Model List of Essential Medicines, highlighting its importance in the pharmaceutical landscape [2]. - The global ketamine market is currently valued at $750 million and is projected to grow to $3.42 billion by 2034, with a compound annual growth rate of 16.4% [2]. - SPRAVATO® (esketamine), an FDA-approved treatment for depression, is on track for a sales run rate of $1.6 billion, with expectations of reaching $3 billion to $3.5 billion by 2027-2028 [2]. - The FDA's approval of KETARx™ comes amid ongoing drug shortages, indicating a significant demand for a reliable supply of ketamine [4]. - The Veterans Health Administration is currently funding ketamine infusions for veterans suffering from depression, PTSD, and chronic pain, further underscoring the therapeutic potential of ketamine [4].
PharmaTher Announces FDA Approval of Ketamine (KETARx™)
Globenewswire· 2025-08-11 13:26
Core Insights - The U.S. FDA has approved PharmaTher's ketamine product, KETARx™, for surgical pain management, marking a significant milestone for the company and positioning it within the psychedelic pharmaceutical sector [1][2][3] Company Overview - PharmaTher Holdings Ltd. aims to become a global leader in ketamine-based pharmaceuticals, focusing on mental health, neurological, and pain disorders [2][5] - The company has a strong commitment to developing ketamine for various therapeutic areas, including depression, Parkinson's disease, ALS, and chronic pain management [3] Market Potential - The global ketamine market is currently valued at $750 million and is projected to grow to $3.42 billion by 2034, reflecting a compound annual growth rate (CAGR) of 16.4% [2] - SPRAVATO® (esketamine), an FDA-approved treatment for depression, is on track for sales of $1.6 billion, with expectations of reaching $3 billion to $3.5 billion by 2027-2028, highlighting the market's potential for KETARx™ [2] Regulatory Context - The FDA's approval of KETARx™ provides a foundation for expanding ketamine's development across various therapeutic areas, addressing a significant need for a consistent, high-quality supply of ketamine [3][4] - The FDA has recognized the importance of expanding research and access to psychedelic therapies, particularly for veterans suffering from mental health issues [4]
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of a Citizen Petition with the US Food and Drug Administration Seeking Removal of Benzethonium Chloride from Ketamine Products
Prnewswire· 2025-08-04 12:03
Core Viewpoint - NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove Benzethonium Chloride from all forms of ketamine sold in the U.S. due to its known toxicity and lack of safety recognition by the FDA [1][2][6] Company Developments - 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 [3] - The company has filed an Abbreviated New Drug Application (ANDA) for a preservative-free ketamine and initiated a New Drug Application (NDA) for NRX-100 (IV ketamine) under the FDA's National Priority Voucher Program for treating suicidal depression [4] - NRx has demonstrated long-term stability and sterility for its preservative-free ketamine, which is crucial for its approval process [6] Industry Context - Benzethonium Chloride is a preservative that has been prohibited in hand cleansers and topical antiseptics by the FDA due to its toxicity [6] - The European Medicines Agency has also warned against the use of Benzethonium Chloride, indicating a growing concern over its safety in pharmaceutical products [2]