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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.
Seems like quiet accumulation. Someone or some entity doesn’t want to draw attention to themself “just yet”
JMHO….3bb
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.
Ditto!
Nice upward accumulation movement for the day. Feels good….
We’ve given up some recent gains over the last few trading sessions.
Hope so
Hope so….
Agree!
Best day’s gone yet….passed 2 weeks of upward trend that is!
NRx Pharmaceuticals Provides Update on Breakthrough Therapy Designation (BTD) Request for ZYESAMI® (aviptadil)
JUNE 10, 2022 10:47PM EDT
Download as PDF
RADNOR, Pa., June 10, 2022 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, NRx Pharmaceuticals), ("NRXP" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) denied the Breakthrough Therapy designation (BTD) request for ZYESAMI® (aviptadil) and emphasized its focus on the company's NRX-101 BTD compound for Bipolar Depression associated with Suicidality. The request for BTD was submitted based on the positive finding of a post-hoc subgroup analysis of patients who in addition to Aviptadil or placebo were also treated with Remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress.
(PRNewsfoto/NRx Pharmaceuticals)
"Although we are disappointed about FDA's decision, as recently announced, our strategic focus has already shifted to the advancement of our Breakthrough Therapy designation drug NRX-101. We expect topline data for our ongoing Phase II study of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation (SSIB) by the end of the year. COVID-19, unfortunately, has also created a mental health crisis, including depression and suicides. Our commitment to helping patients with high unmet needs remains at the core of our work," said Robert Besthof, interim CEO of NRx Pharmaceuticals.
"Given ZYESAMI's mechanism and its well characterized safety profile, NRx Pharmaceuticals will further evaluate the options for its use in other high unmet pulmonary as well as other non-pulmonary indications."
I second that!
Does anyone have any thoughts or perspective on what is brewing?
I saw that too and I am wondering the same thing…?
Oh so true….me too!!!
lol....you're most welcome.
Have a good day!
Milestones....
1. Complete FDA Phase 3 study in COVID-19
2. Manufacture proprietary oral psilocybin thin film strip for clinical research via
agreement with LTS.
3. Complete Biosynthesis studies
4. Clinical study in Methamphet amine use disorder
5. Initiate clinical study (TBI) Traumatic Brain Injury and Stroke
6. Conduct research and development of formulations
7. Initiate clinical study in AIH
Operations Highlights
August 17, 2021, entered into an exclusive license agreement (the
“Agreement”) with Puerto Rico Science Technology and Research Trust (“PRSTRT”)
September 21, 2021, announced that AdvisorShares® Investments LLC
(“AdvisorShares”) included Revive Therapeutics in the inaugural launch of its AdvisorShares Psychedelics ETF (“PSIL”).
October 26, 2021, update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with
mild to moderate COVID-19.
November 16, 2021, announced a research study, titled “Thiol drugs decrease SARSCoV-2 lung injury in vivo and disrupt SARS-CoV-2 spike complex binding to ACE2 in vitro”
November 23, 2021, filed an application with the FDA to receive Orphan
Drug Designation ("ODD") for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver
transplantation.
December 3, 2021, announced decision to expand research with Bucillamine.
January 17, 2022, update on the Company’s psilocybin pharmaceutical
development programs.
January 18, 2022, the Company provided an update on the Company’s U.S. FDA Phase 3 clinical trial
(the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine.
February 15, 2022, the Company announced that the U.S. FDA granted Orphan Drug Designation for
Bucillamine for he prevention of ischemia-reperfusion injury during liver transplantation.
February 24, 2022, HAVN Life Sciences Inc. (HAVN Life”), announced that it secured a purchase order for naturally derived psilocybin from the Company. The Company previously signed a supply agreement with HAVN Life. in October 2021.
April 18, 2022, announced the publication of a scientific article evaluating the impact of medication, including Bucillamine, on antibody response to SARS-CoV-2 mRNA vaccines in Japanese patients with rheumatic diseases.
May 26, 2022, update on FDA Phase 3 clinical trial to evaluate
the safety and efficacy of Bucillamine.
A lot is going on….
IMHO…..yes and yes.
Solid information about all of the positives happening within the company. Looks like an exciting 2023 before us.
Excellent post Mike
Takes a minute.
Hey….what’s wrong with Harold? Lol
Any thing “new” on the horizon?
Looks like retail buyers woke up with faith. Happy days are a coming…
Damn just lost all respect and admiration for his moxie. Disappointed.
We’ll said Minnie. Good to see you…reach out when you have time.
Interesting developments brewing on capital hill.
In Letter to FDA and NIAID, Ron Johnson Demands to Know Why Promising Late-Stage COVID Drug Was Never Approved
By Debra Heine
March 9, 2022
A little-known safe, and potentially life-saving drug for treating patients with severe, late-stage COVID, was purposefully ignored by U.S. health officials, and a group of Congressional Republicans led by Wisconsin Senator Ron Johnson are demanding to know why.
ZYESAMI (off-patent aviptadil) has shown promise as a treatment for COVID patients who are suffering with severe lung inflammation following an excessive immune response known as a “cytokine storm.” The drug is available through the “Right to Try” law—passed by Congress in 2018—but the Food and Drug Administration (FDA), and National Institute of Allergy and Infectious Diseases (NIAID) have failed to recommend it, so it remains largely unknown as a treatment option.
Unlike repurposed drugs like Hydroxychloroquine, and Ivermectin—which were not created to treat COVID symptoms—Aviptadil before the pandemic already had a track record for treating pulmonary inflammation conditions.
According to the Blaze’s Daniel Horowitz, the FDA allowed aviptadil to be prescribed to treat patients with Acute respiratory distress syndrome (ARDS) under the “orphan drug designation” way back in 2001. Orphan drugs are pharmaceutical agents that are not profitable because they treat rare medical conditions, and thus require government assistance to produce. They are used to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients.
Aviptadil was also awarded the orphan drug destination for pulmonary arterial hypertension in 2005, and for pulmonary sarcoidosis in 2021, Horowitz reported. Unfortunately, it has never been fully approved by the FDA.
No not from what I’m seeing. Nothing worth the risk at least right now.
Ahhh ok….I’ve been watching off and on couple of months. Do you watch ipix too?
Ditto…well said.
Ditto…we’ll said!”
Can anyone provide insight as to why the price has dropped so much over the past quarter. New releases and articles all seem to point to positive developments. What am I missing?
TIA
3BB
Thank you so much for further explanation. The link explaining was perfect to understand. Thanks again!
Oh okay. I just learned something new….thanks. Seems to have lots of upside potential.
My bad….if Question seems dumb
Apologies if this question sheets done but what is a mirror stock?
Do you mean .057?
Huge blocks in play