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Probably run up to FDA decision in April 2024.
PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine
https://finance.yahoo.com/news/pharmather-provides-priority-original-abbreviated-130000660.html
Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”
Nice volume recently. GLTa shareholders
$PHRRF 80% strong buy opportunity from @Barchart
https://www.barchart.com/stocks/quotes/PHRRF/opinion
Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024. In anticipation of a potential FDA approval, we are focusing on the commercial scale-up of ketamine in the U.S. and seeking additional international approvals.”
PHRRF continuing that nice climb upwards today. GLTA shareholders
52 week high again today. GLTA shareholders
$PHRRF Strong buy from technical analysis from tradingview https://www.tradingview.com/symbols/OTC-PHRRF/technicals/
I think we will do well here,it seems like a sure thing that we will be marketing this in early 2024.GLTA
$PHRRF $PHRM The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications.
@RexWiggins12
https://thenew.money/article/hedge-fund-billionaire-steve-cohen-is-betting-on-psychedelics
$PHRRF News Out! PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX™ (Ketamine) to the FDA
https://finance.yahoo.com/news/pharmather-submits-priority-original-abbreviated-113000329.html
$PHRRF Update : September 2023 Corporate Presentation https://www.pharmather.com/uploads/1/2/5/8/125844350/deck_-_phrm_-_1020201.pdf
#Ketamine #psychedelics #cepharanthine $PHRM $PHRM.C
$PHRRF
Transdermal Medical Patch Market worth $10.79 Billion by 2028 - Exclusive Report by The Insight Partners
Global transdermal medical patch market is growing at a CAGR of 4% from 2023 to 2028.
@RexWiggins12
https://globenewswire.com/news-release/2023/09/04/2736780/0/en/Transdermal-Medical-Patch-Market-worth-10-79-Billion-by-2028-Exclusive-Report-by-The-Insight-Partners.html
Certainly encouraging.
Interesting that PHRRF and RVVTF mentioned in the article below. GLTA
From the article below:
“In February 2023, Revive Therapeutics Ltd. entered into a research collaboration agreement with PharmaTher Holdings Ltd. to evaluate the delivery of 3,4-Methylenedioxymethamphetamine ("MDMA") using PharmaTher's novel microneedle patch ("MN-Patch") delivery technology. The MDMA MN-Patch enables flexible drug load capacity and combinations, controlled released delivery, and the ability to present desired pharmacokinetic and safety profiles, overcoming the potential obstacles of oral dosing.”
Nice DD here. - PHRRF https://www.barchart.com/stocks/quotes/PHRRF/cheat-sheet
PharmaTher Initiates Filing of Abbreviated New Drug Application for KETARX™ (racemic ketamine) to the FDA
June 27, 2023 - 7:00 am
Expected FDA approval for KETARX™ (racemic ketamine) via the ANDA pathway in Q1-2024 and commercial launch in Q2-2024
TORONTO, June 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, 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.
Ketamine is an essential medicine used for anesthesia and analgesia (pain relief) listed on the WHO Essential Medicines List. Ketamine has been on the FDA’s drug shortage list since February 2018. In Canada, ketamine has been classified as a Tier 3 drug shortage since February 2023, and Health Canada has approved ketamine for use as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various disorders encompassing mental health, neurological and pain. A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.
PharmaTher’s priority is to commercialize KETARX™ in the U.S. under ketamine’s FDA-approved label through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company. The Company expects to market various dosage forms of KETARX™, such as 10 mg/ml, 50 mg/ml and 100 mg/ml, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) develops and commercializes specialty pharmaceuticals exhibiting growing adoption and permitting novel delivery methods to enhance patient outcomes. The Company’s lead product is KETARX™ (racemic ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The Company is commercializing PharmaPatch™ (microneedle patch) with its partners to deliver psychedelics and drugs to treat infectious diseases. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
News release won’t copy and paste but solid news today
Expected FDA approval for KEYARX(TM) (racemic ketamine) via the a ANDA pathway in Q1, 2024 and commercial launch in queue to 2024
Bout time!
Looking good here
Looking forward to more updates from PHRRF
When are we going to move and stay north of .10….?
$PHRRF NEW ARTICLE : PharmaTher Holdings Announces Update of Type C Meeting with the FDA for KETARX™ (Ketamine) in Parkinson's Disease
https://www.pharmather.com/news/pharmather-holdings-provides-update-for-ketarxtm-racemic-ketamine-development-programs-and-expected-milestones-for-2023#:~:text=KETARX%E2%84%A2%20Type%20C%20meeting%20granted%20by%20FDA%20for,treatment%20of%20levodopa-induced%20dyskinesia%20in%20Parkinson%E2%80%99s%20disease%20%28%E2%80%9CLID-PD%E2%80%9D%29.
PHRRF making some nice moves up. GLTA shareholders
Proposed KETARX on-body pump kit and application.
https://charts.stocktwits-cdn.com/production/original_510789717.png
(Posted on Stocktwits)
Agreed. GLTA shareholders
Wish I’d bought more in the .05-08 range.
Agreed. Looking forward to more updates and good news
GLTA shareholders
Nice advancements for the company.
PHRRF made a nice move up recently.
GLTA shareholders
PharmaTher Enters into Exclusive Option Agreement with Case Western Reserve University to Develop and Commercialize Ketamine for Rett Syndrome
Post published:November 2, 2022
Post category:Press Release
TORONTO, Nov. 01, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, is pleased to announce that the Company has entered into an evaluation and exclusive option agreement (the “Agreement”) with Case Western Reserve University (“CWRU”) in the development and commercialization for the intellectual property of ketamine in the treatment Rett Syndrome, a rare genetic neurological disorder. 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,” said Fabio Chianelli, CEO of PharmaTher. “In research, ketamine has shown the potential for treating Rett syndrome. We will work with CWRU and the clinical trial team in pursuing discussions with the FDA to determine all regulatory and clinical options that could expedite the pathway towards having ketamine available for Rett syndrome patients.”
Currently, there is no known cure or FDA-approved drugs for treating Rett syndrome. According to the Rett Syndrome Foundation, Rett syndrome is a rare genetic neurological disorder that occurs almost exclusively in girls. It leads to severe impairments in their ability to speak, walk, eat, and even breathe easily. Prominent features of Rett syndrome include near constant repetitive hand movements and loss of purposeful hand use. Rett syndrome is usually recognized in children between 6 to 18 months. Rett syndrome is caused by mutations on the X chromosome on a gene called MECP2. Rett syndrome occurs worldwide in 1 of every 10,000 female births, and is much rarer in boys.
Ketamine has the potential to treat Rett syndrome, which has been independently validated in two different laboratories in two different strains of Mecp2 mice and has completed a Phase 2 clinical trial with Rett syndrome, with results not published. The therapeutic potential of ketamine for treating Rett syndrome was first demonstrated by Dr. David M. Katz, Professor Emeritus, Department of Neurosciences, School of Medicine at CWRU, and colleagues, who found that treatment of heterozygous female Mecp2 mutant mice with a subanesthetic dose of ketamine (8 mg/kg) acutely reversed abnormalities in Fos expression and sensorimotor function [1]. Chronic administration of ketamine was also found to improve symptoms and extend lifespan in null male Mecp2 mutants [2]. The ability of low-dose ketamine to improve function across a broad range of symptoms may be related to its ability to increase cortical network activity, possibly by selective inhibition of GABAergic interneurons [3], as well as to decrease synaptic excitability in brainstem networks important for respiratory and autonomic control [4]. Thus, ketamine may be ideally suited to redress the imbalance between cortical and brainstem activity that characterizes the MeCP2-deficient brain. Moreover, in addition to its acute effects on circuit function, work in other disease models has shown that ketamine also rapidly stimulates dendritic growth, BDNF levels, and expression of key synaptic proteins [5, 6], at least in part through activation of mTOR signaling, which is deficient in Mecp2 mutants [7]. These findings suggest that, in addition to acute rescue of neurological function, ketamine also has the potential to promote synaptic repair in Rett syndrome by enhancing structural and functional connectivity, as previously shown in animal models of depression and stress [8].
Under the terms of the Agreement, PharmaTher gained an exclusive option for up to 12 months to evaluate the regulatory, 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, “Composition and method for the treatment of pervasive development disorders”, and US provisional patent no. 62/004,695 entitled, “Acute and sustained effects of low-dose ketamine treatment in mouse models of Rett Syndrome.” Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and should the Company elect to exercise its option, both the Company and CWRU will negotiate a license agreement.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders. PharmaTher’s product portfolio consists of KETARX™ (ketamine) delivered by intravenous injection, intradermal microneedle patch, and subcutaneous pump administration. Learn more at PharmaTher.com.
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
June 15, 2022
H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating on PharmaTher Holdings Ltd (PHRRF – Research Report) yesterday and set a price target of C$5.00. The company’s shares closed last Tuesday at $0.13, close to its 52-week low of $0.08.
KETABET™ (Ketamine and Betaine) shown effectiveness as measured by the Clinician Administered Dissociative States Scale
Study results are adequate to give an effect size in powering a placebo-controlled clinical study
PharmaTher planning a Phase 2 clinical study to incorporate KETABET™ in its proprietary microneedle patch for depression
TORONTO, June 07, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive results from an investigator-led observational study (the “Study”) evaluating the impact of KETABET™, a patented drug combination of FDA-approved ketamine and betaine anhydrous, on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. KETABET™ aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.
Cheap seems to be over. Wanted more at 0.1.
The quartery report seemed to be good to me.
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