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PharmaTher Holdings Ltd. (OTCQB: PHRRF) is a biopharmaceutical company focused on the development and commercialization of KETARX™ (Ketamine) to address global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The company also owns 49% of Sairiyo Therapeutics Inc., which is advancing the clinical development of an improved enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for treating responsive cancers and infectious diseases, including COVID-19.
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PharmaTher announced that its subsidiary Sairiyo Therapeutics has completed the clinical and regulatory package for a Phase 1 study of a reformulated version of cepharanthine for infectious diseases and oncology. Sairiyo plans to conduct the study in Australia and then apply for FDA approval to begin clinical trials in the United States.
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PharmaTher Holdings received a Complete Response Letter (CRL) for its Priority Original Abbreviated New Drug Application (ANDA) for Ketamine from the FDA. The Company has addressed the deficiencies mentioned in the review letter and will submit the necessary tests and responses to obtain a revised GDUFA goal date. The CEO is optimistic about the FDA approval for ketamine, aiming to alleviate the ketamine shortage problem in the U.S. and pursue international approvals for ketamine's novel uses. Ketamine is listed as an essential medicine by WHO and has demonstrated effectiveness in treating mental health disorders like depression and anxiety.
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PharmaTher provides an update on its Priority Original Abbreviated New Drug Application for Ketamine, accepted by the FDA with a goal date of April 29, 2024. The Company aims to address possible deficiencies identified by Quality reviewers and submit responses by the end of the week. PharmaTher's long-term strategy includes pursuing novel uses and delivery methods of ketamine for pain, mental health, and neurological disorders.
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PharmaTher Holdings Ltd. announced that its subsidiary, Sairiyo Therapeutics Inc., has initiated a Phase 1 clinical study in Australia for its patented reformulated version of cepharanthine, PD-001, to treat oncology and infectious diseases. Sairiyo is set to benefit from drug development incentives in Australia and aims to manufacture clinical batches by Q2-2024.
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PharmaTher Holdings Ltd. provides an update on its Priority Original Abbreviated New Drug Application for Ketamine accepted by the FDA. The Company aims to address possible deficiencies before the goal date of April 29, 2024, to solve the ketamine shortage problem in the U.S. and pursue international approvals. Ketamine, an essential medicine, is being used for various mental health, neurological, and pain disorders.
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PharmaTher Holdings Ltd. (PHRRF) is on track to receive FDA approval for its lead drug, ketamine, with an assigned approval goal date of April 29, 2024. The company aims to address the ketamine shortage problem in the U.S. and anticipates the commercial launch of ketamine in 2024, followed by international approvals. Ketamine has potential applications in anesthesia, sedation, pain, mental health, and neurological disorders, with recent studies demonstrating its effectiveness in treating depression, anxiety, and suicidal ideation.
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PharmaTher's KETARX™ (racemic ketamine) receives FDA acceptance for Abbreviated New Drug Application (ANDA) with a goal date of April 29, 2024. Commercial launch in the U.S. expected after that, followed by pursuit of international approvals. Ketamine's potential for mental health, neurological, and pain disorders gaining momentum. Recently published study shows significant patient improvement. Partnership with Vitruvias Therapeutics to commercialize KETARX™ in the U.S.
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PharmaTher submits priority original ANDA for KETARX to FDA, anticipates approval and commercial launch in Q2-2024
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PharmaTher Holdings has filed a Pre-Submission Facility Correspondence to support expedited review of its priority ANDA for KETARX™ (racemic ketamine). The company anticipates FDA approval in Q1-2024 and commercial launch in Q2-2024.
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FAQ
What is the current stock price of PHARMATHER HLDGS (PHRRF)?
The current stock price of PHARMATHER HLDGS (PHRRF) is $0.15546 as of December 23, 2024.
What is the market cap of PHARMATHER HLDGS (PHRRF)?
The market cap of PHARMATHER HLDGS (PHRRF) is approximately 14.6M.
What is PharmaTher Holdings Ltd. focused on?
PharmaTher Holdings Ltd. is focused on developing and commercializing KETARX™ (Ketamine) to address global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications.
What is the subsidiary owned by PharmaTher Holdings Ltd.?
PharmaTher Holdings Ltd. owns 49% of Sairiyo Therapeutics Inc., which is advancing the clinical development of an improved enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for treating responsive cancers and infectious diseases, including COVID-19.
What is the goal of PharmaTher Holdings Ltd.?
The overall goal of PharmaTher Holdings Ltd. is to solve the ketamine shortage problem in the U.S. and adhere to the FDA’s strict manufacturing guidelines and FDA-approved prescribing label.
Why is ketamine important?
Ketamine is an essential medicine used for anesthesia and pain relief, listed on the WHO Essential Medicines List. It is also being explored for various mental health, neurological, and pain disorders.
What does PD-001 address?
PD-001 is an improved enteric-coated orally bioavailable formulation of cepharanthine developed to treat responsive cancers and infectious diseases, including COVID-19.
What are the key initiatives of PharmaTher Holdings Ltd.?
PharmaTher Holdings Ltd. aims to obtain FDA approval for ketamine, pursue international approvals, and explore novel uses and delivery methods for ketamine.
What is the patent status of PD-001?
PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036.
What is the clinical strategy for PD-001?
The clinical strategy for PD-001 involves conducting a first-in-human clinical study in Australia to capitalize on drug development incentives, followed by submitting an Investigational New Drug application to the FDA for clinical trials in the U.S.
What is the objective of Sairiyo Therapeutics Inc.?
Sairiyo Therapeutics Inc., owned by PharmaTher Holdings Ltd., focuses on advancing the clinical development of PD-001 for treating cancers and infectious diseases.
How can I contact PharmaTher Holdings Ltd. for more information?
For more information about PharmaTher, you can contact Fabio Chianelli, the Chief Executive Officer, at 1-888-846-3171 or via email at info@pharmather.com.
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