PHARMATHER HLDGS LTD - PHRRF STOCK NEWS

PharmaTher Holdings announced that the FDA has granted a post-complete letter clarification meeting scheduled for December 2, 2024, following a Complete Response Letter (CRL) issued on October 22, 2024, for their ketamine Abbreviated New Drug Application. The deficiencies cited in the CRL are classified as MINOR, requiring new and updated information related to drug substance, product, manufacturing, and microbiology. The FDA expressed no concerns about ketamine submission batch stability and requested no new preclinical or clinical studies. The resubmission will be considered a MINOR AMENDMENT.

PharmaTher Holdings (OTCQB: PHRRF) announced that the FDA granted their request for a post-complete letter clarification meeting following a Complete Response Letter (CRL) received on October 22, 2024, regarding their ketamine Abbreviated New Drug Application. The meeting, initially scheduled for November 29, 2024, is pending rescheduling due to the U.S. Thanksgiving Holiday. The CRL deficiencies are classified as minor, requiring new information related to drug substance, product, manufacturing, and microbiology. No concerns were raised about ketamine stability or need for additional clinical studies. The company aims to address the U.S. ketamine shortage, noting that ketamine has been on the FDA's drug shortage list since February 2018.

PharmaTher Holdings (OTCQB: PHRRF) received a Complete Response Letter (CRL) from the FDA for its ketamine Abbreviated New Drug Application. The FDA cited minor deficiencies requesting new information related to drug substance, product, manufacturing, and microbiology. No concerns were expressed about stability testing, and no additional preclinical or clinical studies were required. The resubmission will be classified as a minor amendment. The company aims to address the U.S. ketamine shortage, noting that ketamine has been on the FDA's drug shortage list since February 2018. The FDA recently issued a risk alert about non-FDA-approved compounded ketamine products for psychiatric disorders.

PharmaTher Holdings (OTCQB: PHRRF) announced an update on its New Drug Application for Ketamine with the FDA. The FDA has assigned a GDUFA goal date of October 29, 2024, and confirmed that the review is ongoing with no additional information needed at this time. Following anticipated FDA approval, PharmaTher aims to pursue international approvals and explore novel uses and delivery methods of ketamine for various indications. The company's goal is to address the ketamine shortage in the U.S., which has been on the FDA's drug shortage list since February 2018. PharmaTher's ketamine will adhere to strict FDA manufacturing guidelines and prescribing labels, addressing concerns about compounded ketamine products not approved for psychiatric disorders.

PharmaDrug Inc. (CSE: PHRX) (OTC: LMLLF) has announced strategic plans to advance the clinical development of PD-001, its patented enteric-coated Cepharanthine formulation, for viral infectious diseases. Sairiyo Therapeutics Inc., 51% owned by PharmaDrug, received approval to initiate a first-in-human Phase 1 clinical study. This follows a $3.4 million contract from the Defense Threat Reduction Agency for the Ebola virus.

PD-001 aims to improve the bioavailability of Cepharanthine, a Japanese-approved drug with potential antiviral activity against various viruses, including coronavirus, HIV-1, and Zika. The new formulation addresses Cepharanthine's low solubility and bioavailability issues, potentially enabling oral administration and eliminating the need for frequent intravenous dosing.

PharmaTher Holdings (OTCQB: PHRRF) (CSE: PHRM) announced that Sairiyo Therapeutics Inc., a company it partially owns, reported independent screening results highlighting cepharanthine's potential to bind to monkeypox (Mpox) proteins. The study, published in the Journal of Infection, showed cepharanthine's significant binding affinities to all ten target proteins of Mpox, with high affinities to four specific proteins (I1L, VITF3L, A42R, and E8L).

This discovery may enhance understanding of viral entry and replication mechanisms for potential Mpox treatments. Additionally, Sairiyo received approval to initiate a first-in-human Phase 1 clinical study with PD-001, targeting Medical Countermeasures. PD-001 previously received a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.

PharmaTher Holdings (OTCQB: PHRRF) announced that Sairiyo Therapeutics, its 49% owned subsidiary, has received approval to initiate a Phase 1 clinical trial for PD-001, a reformulated enteric coated version of oral cepharanthine. The study aims to assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers. This milestone follows years of research and development and a $3.4 million contract from the Defense Threat Reduction Agency for Ebola virus research.

The trial's completion will support Sairiyo's submission of an Investigational New Drug application to the FDA for Phase 2 and 3 clinical trials in the United States. PD-001 is being developed as a potential treatment for Medical Countermeasures and cancer, with applications in infectious diseases, terrorist attacks, and pandemics.

PharmaTher, a specialty pharmaceutical company, announced that Sairiyo Therapeutics, a company partly owned by PharmaTher, has submitted a Clinical Trial Application for a Phase 1 study of its reformulated cepharanthine (PD-001). The study will assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers, comparing different dosages. Set to begin in June 2024 upon approval from Australian regulators, this will be the first human trial of PD-001. Sairiyo aims to take advantage of Australia's 43.5% R&D tax incentive and plans to pursue further trials in the U.S. upon successful completion.

PharmaTher Holdings announced receiving an Amendment Acknowledgment Letter from the FDA for its Priority Original Abbreviated New Drug Application for Ketamine, with a goal date of October 29, 2024. The company addressed FDA comments promptly to meet the goal date. PharmaTher aims to solve the ketamine shortage problem in the U.S., adhere to FDA guidelines, and expand globally. They focus on novel uses of ketamine for pain, mental health, and neurological disorders.