Ketarx (ketamine) / PharmaTher - LARVOL DELTA

PharmaTher Provides Update on Ketamine Program for LID-Parkinson's Disease (Newsfile) - "PharmaTher's objective is to continue the development of its ketamine program for LID-PD via the 505(b)(2) regulatory pathway, leveraging existing scientific and clinical evidence together with the Company's FDA-reviewed Chemistry, Manufacturing and Controls (CMC) foundation to reduce development risk, cost and timelines....Q4 2025-Q1 2026: Submit Pre-Phase 3 FDA meeting request and briefing package; hold meeting and receive minutes (timing subject to Agency scheduling); Q1-Q2 2026: Finalize pivotal protocol (endpoints, inclusion/exclusion, statistical plan) based on FDA feedback; 1H 2026 and onward: Initiate late-stage study, contingent on FDA alignment and financing/partnering; provide periodic updates on enrollment, safety and business development activities."

FDA event • New P3 trial • Parkinson's Disease

PharmaTher Provides Corporate Update Following FDA Approval of Ketamine (KETARx) (GlobeNewswire) - "The Company anticipates a definitive agreement on or before Q4-2025 to accelerate U.S. and select international launches...The Company expects to submit this NDA to the FDA by the end of Q4-2025, with hopes for a Prescription Drug User Fee Act (PDUFA) date by Q4-2026....Additionally, PharmaTher plans to submit another NDA for KETARx to treat a different rare disorder by Q1-2026; details will be released closer to the filing to maintain competitive advantage."

Commercial • FDA filing • PDUFA • Pain • Rare Diseases

PharmaTher Announces FDA Approval of Ketamine (KETARx) (GlobeNewswire)

FDA approval • Pain

Pharmather eyes commercialization of Parkinson’s ketamine treatment (Parkinson's News Today) - "Pharmather is advancing its ketamine-based treatment for Parkinson’s disease as the approval decision date of Aug. 9, 2025, set by the U.S. Food and Drug Administration (FDA) draws closer...If approved, the company plans to market the product under the brand name Ketarx and expand its use in neurological conditions, including Parkinson’s, where ketamine’s potential to ease symptoms such as tremors and dyskinesia, or involuntary movements, is being actively explored....A Phase 2 clinical trial (NCT04912115), sponsored by the company, demonstrated that ketamine reduced dyskinesia induced by levodopa."

PDUFA • CNS Disorders

PharmaTher Secures Key US Patent for Ketamine in Amyotrophic Lateral Sclerosis (ALS), Bolstering its Orphan Drug Designated Program and Targeting a Billion Dollar Market (Taiwan News) - "PharmaTher Holdings Ltd...is pleased to announce that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,128,012, expiring May 14, 2041, for the use of ketamine in the treatment of Amyotrophic Lateral Sclerosis (ALS)....This newly issued patent significantly strengthens the Company’s intellectual property portfolio and provides robust protection for its clinical development program for ketamine in ALS."

Patent • Amyotrophic Lateral Sclerosis

PharmaTher Announces FDA Extends Review Period for Ketamine; New Approval Goal Date August 9, 2025 (GlobeNewswire) - "PharmaTher Holdings Ltd...today announced the U.S. Food and Drug Administration (FDA) has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, 2025, revised from the previous date of June 4, 2025. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA's Complete Response Letter dated October 22, 2024."

PDUFA • Pain

PharmaTher Receives US FDA Approval Goal Date for Ketamine (GlobeNewswire) - "PharmaTher Holdings Ltd...is pleased to announce today that the Company has received an Amendment Acknowledgement Letter ('AAL') from the U.S. Food and Drug Administration ('FDA') for its New Drug Application for Ketamine. In the AAL, the FDA determined this is a minor amendment, meets the criteria for priority review, and assigned an approval goal date of June 4, 2025."

PDUFA • Pain

PharmaTher Provides Update on FDA New Drug Application for Ketamine (GlobeNewswire) - "PharmaTher Holdings Ltd...today announced that the Company is on track to resubmit information to the FDA by end-February 2025. This resubmission, which addresses the deficiencies classified as MINOR in the complete response letter ('CRL') provided by the FDA dated October 22, 2024, is a significant step towards obtaining FDA approval. The Company expects to receive a new approval date for a Q2-2025 FDA approval. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology."

ANDA • Pain

PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application (GlobeNewswire) - "PharmaTher Holdings Ltd...announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 ('GDUFA') goal date of October 29, 2024....As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR."

CRL • Pain

PharmaTher Announces Update on FDA New Drug Application for Ketamine (GlobeNewswire) - "PharmaTher Holdings Ltd...announced an update for its New Drug Application for Ketamine from the U.S. Food and Drug Administration (the 'FDA') with an assigned a Generic Drug User Fee Amendments of 2022 ('GDUFA') goal date of October 29, 2024. On September 3, 2024, the FDA communicated with the Company that the review is ongoing and no additional information is needed, but is subject to change. The Company will continue to provide updates as they occur."

FDA event • CNS Disorders • Parkinson's Disease

PharmaTher Provides Update for Expected FDA Approval of Ketamine (GlobeNewswire) - "PharmaTher Holdings Ltd...is pleased to provide an update for the Company’s lead drug, ketamine ('KETARX™'), as a potential treatment for anesthesia, sedation, pain, mental health, and neurological indications. On September 27, 2023, the Company announced that the U.S. Food and Drug Administration ('FDA') had accepted the priority original Abbreviated New Drug Application ('ANDA') for ketamine and assigned an approval goal date of April 29, 2024. The assigned FDA approval goal date is still on track....The Company’s overall goal is to solve the ketamine shortage problem in the U.S. and anticipates the commercial launch of ketamine in 2024..."

ANDA • Generic launch • Amyotrophic Lateral Sclerosis • CNS Disorders • Epilepsy • Pain • Parkinson's Disease

Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia (clinicaltrials.gov) - P2 | N=30 | Suspended | Sponsor: PharmaTher Inc. | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Anesthesia • CNS Disorders • Movement Disorders • Parkinson's Disease

PharmaTher Announces FDA Acceptance, As a Priority Original Abbreviated New Drug Application, for KETARX (Ketamine) (GlobeNewswire) - "PharmaTher Holdings Ltd...announced the U.S. Food and Drug Administration ('FDA') has accepted the Abbreviated New Drug Application ('ANDA') for KETARX™ (racemic ketamine) to the Food and Drug Administration ('FDA'). The FDA assigned a Generic Drug User Fee Amendments of 2022 ('GDUFA') goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine."

ANDA • Amyotrophic Lateral Sclerosis • CNS Disorders • Pain • Parkinson's Disease

PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX (Ketamine) to the FDA (GlobeNewswire) - "PharmaTher Holdings Ltd...is pleased to announce it has submitted a priority original Abbreviated New Drug Application ('ANDA') for KETARX™ (racemic ketamine) to the Food and Drug Administration ('FDA') for expedited review of its ANDA. The Company anticipates KETARX™ approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine."

ANDA • Amyotrophic Lateral Sclerosis • CNS Disorders • Epilepsy • Pain • Parkinson's Disease

PharmaTher Initiates Filing of Abbreviated New Drug Application for KETARX (racemic ketamine) to the FDA (GlobeNewswire) - "PharmaTher Holdings...is pleased to announce it has filed a Pre-Submission Facility Correspondence in advance of its Abbreviated New Drug Application ('ANDA') for KETARX™ (racemic ketamine) to the Food and Drug Administration ('FDA') to support expedited review of its priority ANDA. The filing of a Pre-Submission Facility Correspondence will help achieve approval early compared to the standard ANDA approval times. The Company anticipates KETARX™ approval from the FDA as early as Q1-2024 and commercial launch in the U.S. in Q2-2024 followed by the pursuit of international approvals to support the growing global demand for ketamine."

ANDA • Launch US • Amyotrophic Lateral Sclerosis • CNS Disorders • Developmental Disorders • Epilepsy • Parkinson's Disease

PharmaTher Holdings Provides Corporate Update (GlobeNewswire) - "PharmaTher Holdings Ltd...provides a corporate update outlining the development and commercialization plans and upcoming milestones for its KETARX™ (racemic ketamine) products and PharmaPatch™ (microneedle patch) delivery system. With approximately CAD $6 million in cash as of end-May 2023, the Company is funded to meet its upcoming milestones targeting near-term investment and revenue opportunities over the next 24 months...The Company expects to file its abbreviated new drug application ('ANDA') with the FDA in early July and obtain FDA approval in Q1-2024."

ANDA • Financing • CNS Disorders • Pain

"@Pharmather_Inc Submits Fast Track Application for Ketarx to US FDA. CHMP Adopts Positive Opinion Recommending @GileadSciences's Hepcludex® (Bulevirtide) for Hepatitis Delta Virus. (2/3)" (@delve_insight)

European regulatory • Hepatology • Inflammation

PharmaTher Holdings Submits Fast Track Application to FDA for KETARX (Ketamine) for the Treatment of Parkinson’s Disease (GlobeNewswire) - "PharmaTher Holdings Ltd...today announced the submission of a Fast Track Application to the U.S. Food and Drug Administration ('FDA') for KETARX™ (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson’s disease ('LID-PD')."

Fast track designation • CNS Disorders • Parkinson's Disease

PharmaTher Holdings Announces Update of Type C Meeting with the FDA for KETARX (Ketamine) in Parkinson’s Disease (GlobeNewswire) - "PharmaTher Holdings Ltd...announced an update on the Type C meeting with the U.S. Food and Drug Administration ('FDA') for advancing KETARX™ (ketamine) towards Phase 3 clinical development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease ('LID-PD')....PharmaTher retains rights to US Patent No: 11,426,366 (expires May 2036), titled 'Compositions and Methods for Treating Motor Disorders,' which includes claims intended to cover ketamine in the potential treatment of Parkinson’s Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body."

FDA event • Patent • CNS Disorders • Parkinson's Disease

PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARX (Ketamine) On-Body Pump System (GlobeNewswire) - “PharmaTher Holdings Ltd…submitted its Type B meeting package with the U.S. Food and Drug Administration ('FDA') to discuss the remaining requirements for the KETARX™ On-Body Pump System (subcutaneous racemic ketamine) and submission of a New Drug Application ('NDA') under the 505(b)(2) pathway. PharmaTher aims to leverage its own CMC information, clinical data and available non-clinical and clinical data to submit an NDA by the end of 2023. The meeting date with the FDA is set for March 23, 2023….Subsequently, should the KETARX™ On-Body Pump System obtain FDA approval, it will allow the Company to leverage its regulatory package and clinical data to expand to mental health (i.e. depression, PTSD), neurological (i.e. Parkinson’s disease) and pain disorders.”

FDA event • NDA • CNS Disorders • Pain • Parkinson's Disease

PharmaTher Holdings Submits FDA Meeting Package to Discuss Phase 3 Program and Fast Track Designation for KETARX (Ketamine) in Parkinson’s Disease (GlobeNewswire) - “PharmaTher Holdings Ltd…submitted its meeting package with the U.S. Food and Drug Administration (‘FDA’) to discuss advancing KETARX™ (racemic ketamine) into Phase 3 development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease (‘LID-PD’). This Type C meeting allows the Company to discuss with the FDA its plans for a Phase 3 clinical study to support the submission of a new drug application under the 505(b)(2) regulatory pathway for KETARX™ in treating LID-PD. In addition, the Company has requested guidance from the FDA to obtain Fast Track Designation for KETARX™. The Type C meeting is via written responses. The goal date for the FDA in providing its written responses is March 20, 2023.”

Fast track designation • FDA event • CNS Disorders • Parkinson's Disease

PharmaTher Holdings Provides Update for KETARX (Racemic Ketamine) Development Programs and Expected Milestones for 2023 (GlobeNewswire) - “KETARX™ for FDA approval to treat Complex Regional Pain Syndrome via the 505(b)(2) regulatory pathway in H2-2023: PharmaTher believes that there is a pathway to submit an NDA with available non-clinical and clinical data, and its own chemistry, manufacturing, and controls (‘CMC’) information by the end of 2023….KETARX™ Type C meeting granted by FDA for potential Phase 3 clinical study in the treatment of levodopa-induced dyskinesia in Parkinson’s disease patients…. PharmaTher retains rights to US Patent No: 11,426,366 (expires May 2036), titled ‘Compositions and Methods for Treating Motor Disorders’…KETARX™ in Phase 2 clinical study in the treatment of ALS: The Company announced that the FDA had accepted an investigator-initiated IND to proceed with a Phase 2 clinical study evaluating ketamine for ALS.”

NDA • New P2 trial • New P3 trial • Patent • Amyotrophic Lateral Sclerosis • CNS Disorders • Pain • Parkinson's Disease

PharmaTher Announces Poster Presentation of Positive Efficacy and Safety Data from Phase 1/2 Clinical Study of Ketamine in the Treatment of Levodopa-Induced Dyskinesia in Parkinson’s Disease at Neuroscience 2022 by the Society for Neuroscience (GlobeNewswire) - P2 | N=30 | NCT04912115 | Sponsor: PharmaTher Inc. | "PharmaTher Holdings Ltd...announced that a poster presentation of the Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson’s disease was presented at Neuroscience 2022 by the Society for Neuroscience being held November 12-16, 2022, at the San Diego Convention Center in San Diego, California. In addition, the Company has engaged the FDA to establish the next steps for a planned Phase 3 clinical study to allow for the Company’s proprietary ketamine intravenous product, KETARX™, approval for Parkinson’s disease under the 505(b)(2) regulatory pathway....The study enrolled 10 subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr. These data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had a reduction in dyskinesias..."

FDA event • P1/2 data • CNS Disorders • Parkinson's Disease

PharmaTher Enters into Exclusive Option Agreement with Case Western Reserve University to Develop and Commercialize Ketamine for Rett Syndrome (GlobeNewswire) - "PharmaTher Holdings Ltd...announce that the Company has entered into an evaluation and exclusive option agreement...with Case Western Reserve University...in the development and commercialization for the intellectual property of ketamine in the treatment Rett Syndrome....Ketamine has been subject to a Phase 2 clinical trial (NCT03633058) for Rett syndrome and unpublished results will be evaluated to support a defined clinical and regulatory plan for FDA feedback. 'We are pleased to have added the Rett syndrome program to our clinical stage product pipeline that focuses on novel uses and delivery forms of ketamine in the treatment of mental health, neurological and pain disorders.'...Under the terms of the Agreement, PharmaTher gained an exclusive option for up to 12 months...clinical development and commercialization plan for CWRU’s intellectual property portfolio, which includes, US issued. patent no. 11,213,494 and US provisional patent no. 62/312,749 entitled."

Licensing / partnership • Patent • CNS Disorders • Developmental Disorders

PharmaTher Holdings Announces Grant of U.S. Patent Covering Ketamine for Parkinson’s Disease (GlobeNewswire) - "PharmaTher Holdings...announce that the United States Patent and Trademark Office ('USPTO') granted US Patent No: 11,426,366, titled 'Compositions and Methods for Treating Motor Disorders,' which includes claims intended to cover ketamine in the potential treatment of Parkinson’s Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body (the 'Patent')....the Company is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow for the Company’s proprietary ketamine intravenous product, KETARX™, approval for Parkinson’s disease under the 505(b)(2) regulatory pathway."

Patent • CNS Disorders • Parkinson's Disease