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PHARMATHER HLDGS LTD - PHRRF STOCK NEWS

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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 Holdings Ltd. has initiated the KET-LID Phase 2 clinical trial to evaluate the safety and efficacy of ketamine for treating levodopa-induced dyskinesia in patients with Parkinson's disease. Patient screening begins in October 2021, with data expected by late-Q4 2021. The study is randomized, double-blind, and active placebo-controlled, focusing on several primary endpoints related to dyskinesia symptoms. If successful, PharmaTher plans to discuss moving to Phase 3 under the 505(b)2 regulatory pathway in 2022.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has appointed Dr. Thomas Laughren as a Regulatory Affairs Advisor to assist in regulatory matters concerning KETABET™, a novel formulation combining FDA-approved ketamine and betaine for treating neuropsychiatric disorders. Dr. Laughren, with 29 years of experience at the FDA, will help finalize the IND application for a Phase 2 study on KETABET™ targeting depression. The treatment aims to mitigate major depressive disorder symptoms in over 300 million people globally, potentially enhancing ketamine's efficacy while reducing its side effects.

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PharmaTher Holdings Ltd. has successfully closed a private placement with institutional investors, raising CAD$10 million. The Company issued 15,625,000 common shares and warrants at CAD$0.64 per share, with each warrant allowing the purchase of one share at CAD$0.80 over five years. Proceeds will fund the development of its microneedle patch program and proprietary ketamine product. The placement agent, H.C. Wainwright & Co., received an 8% commission and warrants. Securities are restricted in the U.S. and not registered under U.S. laws.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) is now part of the North American Psychedelics Index, included in the Horizons Psychedelic Stock Index ETF (NEO: PSYK). This Index focuses on public companies in the psychedelics sector and aims to reflect the industry's evolution. CEO Fabio Chianelli stated that this inclusion enhances investor awareness and boosts confidence in PharmaTher's business model, which emphasizes research and development of ketamine treatments for mental health and neurological disorders. The Index is regularly rebalanced quarterly.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced significant advancements in its clinical pipeline, including a Phase 2 study using ketamine for Parkinson's disease, with 10 U.S. clinical sites selected. The IND for KETABET™, aimed at treating depression, is set for submission in October 2021. Additionally, the company completed its Phase 2 protocol for ALS treatment and is developing microneedle patches for psychedelics. With FDA approvals and a focus on commercialization in 2022, PharmaTher is positioned as a leader in psychedelic therapies.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO Fabio Chianelli will present updates on the company’s FDA Phase 2 clinical studies involving ketamine for conditions like Parkinson’s disease and treatment-resistant depression. The firm is also developing microneedle patches for psychedelic delivery. This presentation will be available to registered attendees for on-demand viewing starting 7:00 AM EST on September 13.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) released its fiscal year results for 2021, highlighting innovative developments in psychedelic therapies. The company solidified four exclusive licensing agreements for ketamine treatments, particularly in Parkinson’s disease and ALS. A key achievement was the FDA approval for a Phase 2 clinical trial on ketamine's efficacy for levodopa-induced dyskinesia. Financially, the company reported net losses of $2.66 million with cash reserves of approximately $5.88 million.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received FDA orphan drug designation for ketamine as a potential treatment for Amyotrophic Lateral Sclerosis (ALS). This significant milestone allows the company to advance to a Phase 2 clinical study in the U.S. CEO Fabio Chianelli emphasized that this validation expedites regulatory and product development plans. With approximately 50,000 ALS patients in the U.S. and a lack of effective treatments, ketamine’s neuroprotective properties could be pivotal. The designation also offers financial incentives and seven years of marketing exclusivity upon regulatory approval.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed a provisional patent for a novel ketamine formulation aimed at intradermal administration, expanding its intellectual property portfolio to 19 patents across over 150 countries. The innovative delivery method bypasses skin barriers, potentially enhancing bioavailability and reducing irritation. CEO Fabio Chianelli highlighted the company's commitment to developing prescription-based ketamine products. PharmaTher's pipeline includes FDA-approved studies for treating Parkinson's disease and novel microneedle patches for psychedelic delivery.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced CEO Fabio Chianelli's participation in the Grizzle Psychedelics Con on June 28, 2021, at 12 PM ET. Chianelli expressed enthusiasm for this virtual conference aimed at investors interested in psychedelics, highlighting PharmaTher's promising product pipeline, including an FDA Phase 2 study of ketamine for Parkinson’s disease and a microneedle patch for delivering psychedelics for mental health and pain disorders. The event will also be available for later viewing.

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FAQ

What is the current stock price of PHARMATHER HLDGS (PHRRF)?

The current stock price of PHARMATHER HLDGS (PHRRF) is $0.15495 as of December 24, 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.

PHARMATHER HLDGS LTD

OTC:PHRRF

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14.61M
71.98M
18.68%
0.06%
Biotechnology
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