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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 has entered into a collaboration agreement with Vitruvias Therapeutics for the commercialization of its KETARX products in the US. The company expects to file its abbreviated new drug application for KETARX with the FDA in July 2023 and obtain FDA approval in Q1-2024. The commercial launch is anticipated in Q2-2024.
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PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced an update regarding its KETARX™ (ketamine) treatment for levodopa-induced dyskinesia in Parkinson's disease, following a Type C meeting with the FDA. The FDA supported the company's regulatory approach and indicated that a single confirmatory trial could suffice for marketing approval under specific conditions. PharmaTher will adjust its clinical development plans according to the FDA's feedback and aims to pursue FDA Fast Track designation. Recent Phase I/II results showed ketamine was safe and well-tolerated, with significant reductions in dyskinesias for all subjects treated.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted its Type B meeting package to the FDA to discuss requirements for the KETARX™ On-Body Pump System. The meeting is scheduled for March 23, 2023. PharmaTher aims to submit a New Drug Application (NDA) by the end of 2023, using its clinical and non-clinical data. The company intends to seek FDA approval for the device to enhance general anesthesia and sedation procedures. The KETARX™ system may provide improved administration of ketamine while potentially extending its use in mental health and pain disorders. However, no assurance of expedited approval is provided.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received its 5th FDA orphan drug designation for KETARX™ (racemic ketamine) to treat Rett Syndrome, a rare neurological disorder that primarily affects girls. This designation paves the way for proposed Phase 3 clinical trials. The company has previously received orphan designations for conditions including Ischemia-reperfusion injury and Status Epilepticus. Currently, no FDA-approved treatments exist for Rett Syndrome, impacting 1 in 10,000 female births. KETARX™ shows potential in treating this condition, validated through prior research and ongoing clinical trials.

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PharmaTher Holdings Ltd. (OTCQB: PHRRF) has submitted a meeting package to the FDA to advance its ketamine product, KETARX™, into Phase 3 development for treating levodopa-induced dyskinesia in Parkinson's disease. The company aims to utilize the 505(b)(2) pathway for a new drug application. Notably, KETARX™ has shown promising results in prior studies, with 100% of subjects experiencing reduced dyskinesias. The FDA is expected to respond by March 20, 2023. Additionally, PharmaTher is seeking Fast Track Designation, which could expedite KETARX™'s development process, benefiting patients with this debilitating condition affecting over 10 million globally.

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PharmaTher Holdings Ltd. has applied for Orphan Drug Designation from the FDA for ketamine to treat Rett Syndrome, a rare neurological disorder. This follows a completed Phase 2 clinical trial, with unpublished results expected to support a future Phase 3 study. The company holds four existing orphan drug designations for ketamine, including conditions such as Status Epilepticus and Amyotrophic Lateral Sclerosis. If approved, ketamine would qualify for marketing exclusivity, tax credits, and other benefits. Rett syndrome affects 1 in 10,000 female births with no current FDA-approved treatments.

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PharmaTher Holdings Ltd. aims to commercialize KETARX™ (racemic ketamine) for mental health, neurological, and pain disorders. The company is seeking FDA approvals via the ANDA and 505(b)(2) pathways by H2-2023. Key development initiatives include Phase 3 studies for Parkinson’s disease and Phase 2 studies for amyotrophic lateral sclerosis (ALS) and microneedle patch delivery. PharmaTher has received four FDA orphan drug designations, enhancing its market potential. The projected revenue from KETARX™ could reach up to USD $40 million based on one million unit sales at an average price of USD $25-40.

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PharmaTher Holdings Ltd. announced that the FDA has granted its fourth orphan drug designation for ketamine, aimed at preventing ischemia-reperfusion injury from organ transplantation. This designation is pivotal as it qualifies ketamine for various benefits including seven years of marketing exclusivity upon regulatory approval. The company now holds four orphan designations for ketamine, targeting conditions like Status Epilepticus and Amyotrophic Lateral Sclerosis. In 2022, there were over 39,000 organ transplants in the U.S., highlighting the ongoing need for effective treatments in this area.

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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
Healthcare
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United States of America
Toronto