3/14/23 *Morning UPDATE*
Greetings Readers,
IKT is riding the green train early on.
Nailing a high of $.89 this morning, IKT is now trading at levels it hasn’t seen in over a month and a half.
And this could just be the start of something really big as a potential squeeze could be occurring as IKT has moved above its 200-Day Simple Moving Average (SMA).
If potential resistance had broken down at that level, IKT would then be firmly trading above 3 of the most important lines of potential support including its 50-Day SMA and 13-Day Exponential Moving Average (EMA).
Lest we forget: Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
That huge news is less than a week old which means it’s probably still circulating.
As more people get eyes on it, IKT could really start garnering some real attention.
For now, keep IKT on radar and wait for my next update coming soon.
Sincerely,
Virtus Junxit
3/14/23 *UPDATE*
Greetings Readers,
IKT made a strong move Monday.
This Nasdaq Biopharma idea increased by approximately 12% from Friday’s closing valuation, and this could just be the start.
The reason for this increase could be due to the huge news the company announced last week: Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics stated, “As with our work in Parkinson’s, preclinical models have highlighted the therapeutic potential of IkT-148009 in MSA. One of two ongoing model studies has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009. With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population.“
Moreover, IKT closed above two key lines of potential support in its 50-Day Simple Moving Average (SMA) and its 13-Day Exponential Moving Average.
Although the company broke through its 200-Day SMA early on Monday, it faced potential resistance at that level that it could not break down.
However, if the 200-Day SMA resistance breaks down, it could set up a potential squeeze scenario for IKT in the near term.
Keep an eye on IKT due to its low float of around 18.48Mn shares, and stay tuned for further updates after the opening bell.
Sincerely,
Virtus Junxit
3/13/23 *Morning UPDATE*
Greetings Readers,
Holy cow. Do you have eyes on IKT this morning? Time could be running out.
Right now, IKT is currently up approximately 16% out of the opening bell with a posted early high of $.7899.
Not bad, but this could just be the start. Here’s what you need to really focus on:
This morning, IKT has moved above 3 important lines of potential support:
- 50-Day Simple Moving Average (SMA)
- 200-Day SMA
- 13-Day Exponential Moving Average
These lines are key. If IKT is able to grow potential support at those levels, it could act as the building blocks for this Nasdaq idea to return to previous highs. Watch these lines closely.
Pus, the company is coming off a huge FDA ruling last week: Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
As this news continues to circulate, it could bring a lot of new attention to this Biopharma profile in the near term.
It also doesn’t hurt that IKT has a low float of about 18.48Mn shares which means volatility could pop up at any given moment.
Drop everything to get IKT pulled up this AM. If any more updates are necessary, I’ll get them out quickly. Talk again soon.
Sincerely,
Virtus Junxit
3/13/23
Greetings Readers,
Let’s get to it quickly because we’ve got some key details to go over.
Starting at $3.31 on March 8th, my latest breakout idea reached a high of $4.54 the next day, resulting in an approximate 37%, 2-day increase.
During after-hours on the 8th, the profile surged to $5.20, an approximate 57% increase from its opening price that same day.
Now, I’ve got a new Biopharma profile (Nasdaq) to bring to your full attention.
Flying under Wall Street’s radar at the moment, this company has an impressive intellectual property (IP) portfolio, including key patents on its technology and methods for treating neurodegenerative and infectious diseases.
Parkinson’s disease is a neurological condition characterized by involuntary or uncontrolled movements, including tremors, rigidity, and impaired coordination and balance.
The projected value of the global Parkinson’s disease treatment market is estimated to exceed $12Bn by 2030.
With a potential treatment on the horizon, companies in this field may have a promising opportunity to secure a significant share of the market.
And while Wall Street still doesn’t have this little-known Biopharma company on its radar yet, it’s time to get them on your radar, especially after a positive FDA ruling.
Drop everything and get this low float Nasdaq idea on your screen now:
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)
Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease, or PD, and related disorders.
We have a lot to go over, especially with last week’s FDA ruling, but before we get too far along, let’s break down this company’s operations.
Company Overview: Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (1)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a company with a multi-therapeutic pipeline that has a primary focus on neurodegeneration.
Their lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson’s disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases.
In 2021, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) commenced clinical development of IkT-148009, a small molecule Abelson Tyrosine Kinase inhibitor which the company believes can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI.
Results to date of the company’s completed Phase 1/1b Single and Multiple Ascending Dose escalation study (SAD and MAD, respectively) in older and elderly healthy volunteers and in mild to moderately advanced Parkinson’s patients have revealed important insights into the safety, tolerability and pharmacokinetics of IkT-148009 in human subjects and patients.
Results from the 88 older and elderly healthy Phase 1 subjects and 14 Phase 1b Parkinson’s patients have shown that IkT-148009 has a half-life of greater than 24 hours and just a 25 mg once-daily oral dose reached exposures that are consistent with the exposures to the drug that resulted in therapeutic efficacy in animal models of progressive Parkinson’s disease.
In addition, review of unblinded adverse event data revealed that just nine adverse events of any grade were observed in subjects or patients on IkT-148009, and at least four of these adverse events could not be attributed to IkT-148009.
The remaining five adverse events were of Grade 1 with no clinical significance.
FDA review of the Phase 1/1b data and the protocol for the Phase 2a three-month dosing study resulted in the FDA agreeing with the company’s view that it was appropriate for the Phase 2a study to begin, prompting them to close the Phase 1b study after two dosing cohorts.
The Phase 2a ‘201′ study began May 23, 2022 with the opening of the first site; the company has opened 16 of 34 selected sites as of November 1, 2022 and 11 patients have been randomized into the trial as of November 1, 2022.
120 treatment naïve patients are planned to be enrolled in this study which will dose patients with one of three planned doses of IkT-148009 or placebo once daily for three months.
In addition to primary endpoints of safety/tolerability/pharmacokinetics, a hierarchy of 15 secondary endpoints measuring drug impact on motor and non-motor features of Parkinson’s disease in the brain or GI tract will be evaluated with descriptive statistics.
In July 2022, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) filed its Investigational New Drug Application (IND) with the FDA in preparation to initiate clinical development of IkT-001Pro, its prodrug of imatinib mesylate to treat Stable-phase Chronic Myelogenous Leukemia (SP-CML).
IkT-001Pro will be evaluated in a two-part dose finding/dose equivalence study in up to 56 healthy volunteers.
The study is designed to evaluate the steady-state pharmacokinetics of IkT-001Pro and determine the dose of IkT-001Pro equivalent to 400 mg imatinib mesylate, the standard-of-care dose for SP-CML. Following clearance of the IND by the FDA on August 26, 2022, the two-part study, now known as the ‘501’ study, was initiated with first patient dosing anticipated by the beginning of December, completion of the first cohort anticipated by year end 2022 and completion of the pharmacokinetic analysis anticipated in early first quarter 2023.
Following completion of both parts of this study and assuming the equivalent dose of IkT-001Pro relative to 400 mg imatinib mesylate is established, Inhibikase Therapeutics, Inc. (Nasdaq: IKT) will confer with the FDA to begin the NDA process following the proposed approval path for IkT-001Pro under the 505(b)(2) statute.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) will simultaneously pursue a superiority study comparing the selected doses of IkT-001Pro to standard-of-care 400 mg imatinib mesylate in SP-CML patients using a novel two-period wait list crossover switching study.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s programs utilize small molecule, oral protein kinase inhibitors to treat neurodegenerative diseases and cancer.
In Parkinson’s disease (PD), Inhibikase Therapeutics, Inc. (Nasdaq: IKT) has shown in animal models of progressive disease that its lead clinical candidate, IkT-148009, is a brain penetrant Abelson tyrosine kinase, or c-Abl inhibitor, that halts disease progression and reverses functional loss in the brain and reverses neurological dysfunction in the GI tract in animal models of human disease.
The ability to halt progression and restore function was shown in animal models of progressive disease that mimic the rate of disease progression and the extent of functional loss in the brain and/or the GI tract as found in patients with PD.
Reversing the Effects of Neurodegenerative Diseases (2)
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s therapeutics development programs focus on halting and reversing the effects of neurodegenerative diseases inside and outside of the brain. The company is also developing therapeutics that target the source of neurological infections.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s pipeline includes multiple products developed from their proprietary RAMP™ dr-ug innovation and prodr-ug technology engines that address multiple indications.
Abl Kinases and CNS Diseases
The protein kinase family known as the Abelson Tyrosine Kinase, or Abl kinases, has been shown to play a critical role in monitoring insults to brain neurons and regulating biological pathways that are associated with neurodegeneration.
In addition, recent research has demonstrated that Abl kinases are essential checkpoint regulators that play a central role in Parkinson’s disease initiation and progression.
The breakthrough cancer treatment, imatinib (marketed as Gleevec®), was the first FDA-approved Abl kinase inhibitor.
However, imatinib cannot treat in the brain nor inhibit the wildtype enzyme in patients, even though it has a favorable safety and pharmacology profile.
Applying Inhibikase Therapeutics, Inc. (Nasdaq: IKT)’s RAMP™ technology to imatinib, Inhibikase generated novel chemical entities that have:
- Up to 25-fold enhanced potency against wildtype c-Abl relative to imatinib
- Cross the blood-brain barrier and treat in the brain
- Nearly identical route of metabolism to imatinib, thereby preserving the relationship between administered dose, drug safety and frequency of adverse events. This provides a level of predictability in a novel drug’s safety profile.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) believes these molecules have the potential to be dosed at low levels with an improved safety profile relative to other drugs in this class currently used to treat certain forms of blood and gastrointestinal cancers, resulting in a safer Abl kinase inhibitor that could be chronically and systemically administered for the treatment of their CNS indications.
Grab the full company presentation here.
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Must-Know (IKT) Details This Second – 3 Potential Catalysts To Know
#1. IKT may see increased attention in the short term following a significant FDA ruling last week.
Read this now:
Inhibikase Therapeutics Announces FDA has Lifted the Full Clinical Hold on IkT-148009 in Multiple System Atrophy
– Advancing model studies of IkT-148009 in MSA; early data has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009 –
– MSA IND Opened, the 5th in the Company’s history –
– Advancing model studies of IkT-148009 in MSA; early data has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009 –
– MSA IND Opened, the 5th in the Company’s history –
– Planned Phase 2a ‘202’ clinical trial will evaluate therapeutic benefit of IkT-148009 over 6 months –
BOSTON and ATLANTA, March 8, 2023 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the U.S. Food and Drug Administration (“FDA” or “Agency”) has lifted the full Clinical Hold on IkT-148009, the Company’s c-Abl inhibitor, in Multiple System Atrophy (MSA) allowing the Company to proceed with its plans for a future Phase 2 clinical trial in MSA.
“We are grateful for the expeditious review by the FDA of our response to the Clinical Hold on IkT-148009 in MSA,” stated Milton H. Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. “As with our work in Parkinson’s, preclinical models have highlighted the therapeutic potential of IkT-148009 in MSA. One of two ongoing model studies has shown a substantial neuroprotective benefit in response to c-Abl inhibition by IkT-148009. With the clinical hold lifted and the IND now open, we look forward to completing these studies prior to initiation of the Phase 2a trial in this patient population.”
…
The planned ‘202’ trial will evaluate the safety, tolerability and pharmacokinetics of IkT-148009 in MSA patients over 6 months of once daily dosing at one of two oral doses. Secondary and exploratory endpoints will evaluate clinical benefit using a modification of the Total Unified MSA Rating Scale (UMSARS), assessment of quality of life. severity of symptoms arising from orthostatic hypotension, and the levels of neurofilament light chain in peripheral blood and spinal fluid. Additionally, biomarkers of treatment benefit will be explored by measuring levels of phosphorylated alpha-synuclein in spinal fluid, peripheral blood and skin. Clinical effect on the progression of atrophy will be monitored in the trial using MRI.
…
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#2. Due to its low float, IKT has the potential for explosive volatility.
No need to beat around the bush – Yahoo Finance reports that IKT has a small float of only about 18.48Mn shares.
This means that IKT could experience sudden and significant fluctuations due to the limited number of shares available for trading.
Similar to many of my other breakout runners, many of which had a low float, it will be important to closely monitor IKT for potential volatility.
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#3. The market opportunity for Parkinson’s Disease treatments is immense, with the global market projected to exceed $12Bn within the next decade. (3)
There is a significant market for treatments related to neurodegenerative and infectious diseases, and IKT could have an opportunity to capture a major share of it.
Market research suggests that the global neurodegenerative disorder therapeutics market could experience a compound annual growth rate (CAGR) of 8.1%, growing from $15.86Bn in 2022 to $17.14Bn in 2023.
The market is expected to continue to grow at a CAGR of 8.4%, reaching $23.65Bn in 2027, driven by an aging population with an increased prevalence of neurodegenerative disorders.
By 2050, the number of people over 60 years of age is estimated to increase to 2.1 billion, with those over 80 years tripling to 425 million.
Additionally, the Alzheimer’s Association predicts that the number of Americans with Alzheimer’s disease will rise to around 14 million by 2050, further boosting demand for neurodegenerative disorder therapeutics.
Given these trends, a treatment from IKT could be nothing more than game-changing.
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Drop what you’re doing right now to get Inhibikase Therapeutics, Inc. (Nasdaq: IKT) on radar. Be in touch again shortly.
Sincerely,
Virtus Junxit
