Pharmather Holdings Ltd - PHRRF STOCK NEWS

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.

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.

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.

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.

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.

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.

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.

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.

PharmaTher submits priority original ANDA for KETARX to FDA, anticipates approval and commercial launch in Q2-2024