While
The better news for CRDL investors- those YTD gains could be the precursor to more appreciable increases, a bullish sentiment supported by CRDL being better positioned than at any time in its history to accelerate its clinical ambitions and, as importantly, deliver a better, safer, and effective way to treat certain cardiovascular diseases. The even better news- that can happen faster than many think, especially from the precedent set by potential category rival
Value Drivers, Milestones, And Catalysts in The Crosshairs
Indeed, while the possibility of having two Phase III trials progressing by the end of 2023 are certainly value drivers, they aren't the only ones. Adding support to an already bullish case, CRDL's latest
Remember, most funds are internally mandated to stay invested in stocks. Yes, they hold cash, but for the most part, it amounts to about 4% or less of the fund's total value. In other words, managers need to find strong companies that are fundamentally and operationally strong, two boxes that CRDL definitely checks. And word is spreading about this
The four covering CRDL are bullish regarding the expected share price trajectory. Current price models forecast CRDL shares to reach between
CRDL checks the long end of that, a premise supported by CRDL's drug candidate earning more than a potential front-line position. Orally administered CardiolRx(TM) is also on a pathway toward achieving FDA orphan drug and EMA orphan medicine designations, providing seven years of market exclusivity to protect potentially significant revenue streams. Those designations can be worth billions over time.
Accelerating Through Phase II With Milestones In-Play
CardiolRx(TM), with its anti-inflammatory and anti-fibrotic properties to treat particular cardiovascular diseases, is headed in that direction. In its immediate treatment crosshairs,
Success to date isn't just a clinical morale builder; it supports the bullish proposition, knowing that milestones reached by CRDL can become catalysts to expedite tapping into multi-billion dollar treatment market opportunities. Three are currently in play. The first relates to its Phase II Recurrent Pericarditis Study, with CRDL potentially announcing completed enrollment, interim analysis, and a move to Phase III clinical trial this year.
Cardiol is also expected to complete enrollment and report topline data from its Phase II acute myocarditis study. That one could also jump directly to Phase III based on its data supporting the need for this drug candidate to get to patients quickly. A third milestone relates to its advancing research for CRD-38, with the company expecting to complete IND-enabling (Investigational New Drug Application) studies, submit the IND, and initiate the Phase I Clinical Program. Positive updates from any of the above could have a material impact on CRDL's share price. With expectations for updates to be published this quarter, trading ahead of them may be a wise consideration.
Fighting Recurrent Pericarditis In Unique Fashion
Keep in mind that expected announcements are likely to further validate that CRDL's drug candidates can do what others can't- fight effectively against myopericardial diseases due to their anti-inflammatory and anti-fibrotic properties. Those latter differences are more than distinctions; they are proving to be significant advantages compared to drugs developed by Big Pharma, including
And they are getting plenty of collaborative help to make sure that happens.
Those relationships are fueling progress, likely expediting a Phase II study evaluating CardiolRx(TM)'s tolerability, safety, and efficacy in patients with recurrent pericarditis. Pericarditis is the membrane inflammation surrounding the heart, which leads to fluid accumulation and pericardial thickening. It becomes recurrent if symptoms reappear after a symptom-free period of 4-6 weeks. The symptoms of pericarditis include chest pain, shortness of breath, and depression. Severe cases affect quality of life and physical activity abilities and can even lead to emergency department visits or hospitalizations. It touches many lives.
Pericarditis affects 38,000 Americans and leads to 18,000 hospitalizations annually. While bad enough, recurrent pericarditis is much worse, usually lasting anywhere from 4-6 years in difficult-to-treat cases. If granted FDA orphan and/or EMA approval, CardiolRx(TM) could fill an unmet medical need for an oral drug that treats patients intolerant to therapy, colchicine resistant, or corticosteroid dependent.
Current pharmacotherapy solutions include NSAIDs or aspirin that don't contain colchicine and corticosteroids for patients with continued recurrence. Moreover, the one FDA-approved therapy that shows some benefit costs over
The Battle Against Acute Myocarditis
Battling acute myocarditis can be equally devastating to a patient's health and finances. Acute myocarditis is an inflammatory heart muscle condition, often resulting from a viral infection. Symptoms include chest pain, impaired heart function, arrhythmia, and conduction disturbances. Most troubling about this condition is that it generally affects young adults from adolescence to mid-thirties. Still, while the affliction age is wide, most cases are recorded in patients in their early twenties, with acute and fulminant heart failure occurring in young adults. In fact, acute myocarditis is a leading cause of sudden cardiac death in people under the age of 35. Athletes, despite being in top physical condition, have died from this. Thus, diet and exercise won't stop an attack. But a better therapy could save lives.
CRDL believes CardiolRx(TM) can be that provider and, at the same time, benefit the company financially by having significant potential to earn FDA orphan drug and EMA approvals for treating acute myocarditis. That condition also takes a personal and financial toll. An estimated 46,000 Americans are impacted by acute myocarditis annually. Hospitalizations can be upwards of 7 days and tally
Thus, a treatment to address problems early on would benefit patients significantly. As importantly, an approved therapy from CRDL could fill a clear unmet medical need for a well-tolerated therapeutic that targets myocardial inflammation. There are no FDA-approved therapies for acute myocarditis, only guideline-directed therapies and management. These therapies include decreasing cardiac workload, reducing congestion, and improving how blood flows through arteries and veins and the forces that affect a patient's blood flow. Currently, corticosteroids are used to treat inflammation. However, the issue with those drugs is that they are widely intolerable, can have adverse side effects, and have an inconsistent record of optimal dosing.
Attracting Attention For The Right Reasons
Combining the known with near-term expectations, suggesting that CRDL's share price fails to appropriately represent intrinsic value, much less inherent potential, is more than warranted; it's justified. In fact, four respected analysts conclude that CRDL stock will more likely be at least 174% higher on the low estimate, 640% on the high, and 328% in the middle. In other words, at
Remember, the bullish case isn't wishful thinking. It's evidence-based by CRDL being timely to a massive market and treatment opportunity, having excellent candidates with intrinsic strength and inherent potential to change the treatment landscape for specific cardiac diseases, and value from collaborative relationships that can help accelerate monetization timelines. All that combines to make the value proposition presented by CRDL stock simply too attractive to ignore. With over six million people over 20 years old currently living with symptoms of heart failure, one can bet they aren't. Nor is the medical system, which is strained by the over 1.9 million physician visits, 414,000 emergency department visits, and an estimated 1.2 million hospitalizations annually.
Thus, CRDL is earning the attention it deserves. And on the precipice of shifting into a late-stage Phase III clinical trial company for potentially two indications, much more could be on its way. If so, and with a potential best therapy to treat patients in a sector worth billions, anything less than the most conservatively modeled 174% increase would be disappointing. Frankly, even the forecast for a 328% increase may still leave considerable value unaccounted.
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The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.
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