An Innovative Biotech Has Stepped up with a Breakthrough That Could Change the treatment paradigm for MDD and GAD
The new drugs it's developing offer new hope to millions of adults suffering with major depressive disorder and generalized anxiety disorder…
By Pete and Jon Najarian, Editors • Rebel Investors Club
More than 30 years after the introduction of Prozac, 322 million people worldwide suffer from major depressive disorder and generalized anxiety disorder 2. Some studies suggest that 1/3 of the US population struggles with these mental health issues.3
Big Pharma has moved on from mental health, redirecting their resources toward headline-grabbing health issues such as cancer and autoimmune diseases — illnesses with clear biological targets for measuring improvement.
And that retreat has opened the door for a new generation of small, agile biotech companies poised to fill the void Big Pharma left behind.
These small firms are driving the most important breakthroughs in depression and anxiety the world has seen in more than 30 years.
And among these next-generation innovators is a company our research reveals may finally have the answers the world has been looking for.
Developing Next-Gen Pharmaceuticals that Actually Work
The company we’re talking about is a NASDAQ biotech called Helus Pharma (NASDAQ: HELP), and it’s developing new pharmaceutical drugs that clinical trials have begun to show promise in treating major depressive disorder (“MDD”) and generalized anxiety disorder (“GAD”).
That’s because its drugs are being evaluated to “rewire” the brain (in a good way) and get adults with MDD and GAD back to their real selves.
They do this by disrupting the brain’s rigid activity patterns, potentially promoting new connections and enhancing its ability to adapt and reorganize those connections.
Phase 2 clinical trials already appear to show that the drugs may work and their effectiveness is durability out to 12 months after 2 doses. Better yet, initial clinical trials thus far show no significant side effects. 4
The new drugs Helus Pharma is developing have their origin in a medical revolution you may have never heard about.
Research from Some of the Most Prestigious Institutions in the World
Naturally derived compounds — many sourced from plants, fungi or other organic materials — have a long history of shaping modern medicine.
Aspirin, originally developed from willow bark, is a classic example of how nature-based compounds can deliver powerful, clinically proven benefits.
Today, researchers at leading medical and academic institutions are continuing this work, studying a range of naturally occurring substances for their potential to support mental health.
Repeated findings show that, when carefully developed and administered in controlled medical settings, naturally occurring compounds like psilocybin can play a meaningful role in improving outcomes for patients struggling with serious mental disorders.
Some institutions studying these compounds include…
- Johns Hopkins Medicine 5
- Yale School of Medicine 6
- University of California San Francisco 7
- NYU Langone Health Center 8
- Imperial College London 9
- Stanford University 10
- University of California, Los Angeles (UCLA) 11
- University of California, San Diego (UCSD) 12
But academic validation is only the first step.
Turning promising natural compounds into reliable, scalable medical treatments requires far more than discovery. It demands precision, consistency, and regulatory-grade manufacturing.
That’s where pharmaceutical engineering enters the picture.
Specially Engineered & Patented Compounds that Could Change the World
Helus Pharma (NASDAQ: HELP) is building on all that research to engineer novel compounds that in Phase 2 clinical trials have shown promise in treating mental health disorders.
The Company’s scientists are creating synthetic molecules specially engineered to be more effective, and may be able to deliver a more predictable and durable therapeutic impact than patients will get from just consuming the natural compound itself.
For you, as an investor, we believe this also makes Helus Pharma an attractive investment because unlike the natural compounds themselves, these novel compounds can be patented.
And that’s what gives Helus Pharma exclusive rights to their novel compounds until 2041.
The Company has already filed more than 350 patents on its compounds, and more than 100 of them have been granted. 13
Based on our research, that’s more than any other company researching the same class of molecules.
More importantly, however, is the success Helus Pharma (NASDAQ: HELP) is already having with clinical studies on the initial drugs in its pharmaceutical pipeline.
That success is the first of our…
Eight Surprising Reasons Why Helus Pharma Could Be a Profitable Investment Opportunity for You
Our research into Helus Pharma (NASDAQ: HELP) revealed an innovative company with compelling, clinical data, and vision to potentially bring life-changing results to millions of people all over the world.
Let’s take a closer look…
Reason #1
Clinical Studies are Already Bringing Positive Results for Helus’s Flagship Drugs
Helus Pharma’s (NASDAQ: HELP) initial focus is on the treatment of two of the world’s most common mental health problems:
1) Major Depressive Disorder (MDD); and…
2) Generalized Anxiety Disorder (GAD)…
…disorders that impact more than 300 million people worldwide.
With that in mind, it advancing it two lead programs with the goal of turning them into pharmaceutical drugs designed to effectively treat these all-to-common mental problems.
Boring Science… Exciting Results
The first is called HLP003, and it’s a proprietary deuterated novel serotonergic agonist (“NSA”) in development for the potential adjunctive treatment of MDD.
We realize that’s an exhausting mouthful, so let us quickly break it down.
- Novel serotonergic agonists or NSAs are synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity (the brain’s ability to reorganize and adapt its structure and function).
- “Deuterated” means the drug has been engineered at the molecular level to slow down how quickly the body breaks it down, making the compound stable.
These qualities may also translate to more predictable dosing making treatments potentially scalable and accessible to more people suffering from MDD.
That’s the boring stuff… here’s the exciting part: In recently completed Phase 2 clinical trials of HLP003, after just two doses, every subject in the trial showed improvement as measured by the Montgomery–Åsberg Depression Rating Scale.
That statistic is worth repeating — every single person participating in the Phase 2 clinical trial referenced above showed improvement in addressing depression symptoms.
What’s more, an astounding 71% reported complete remission of their depressive symptoms 12 months after treatment — something that’s almost unheard-of with antidepressants, especially after just two doses.14
All without any significant side-effects reported.
Phase 3 Clinical Trials Are Underway
Better yet, the results were good enough to quickly move HLP003 to Phase 3 trials.
Phase 3 is designed to test how HLP003 performs in a larger population of participants.
The company’s Phase 3 “Paradigm” program got underway in mid-2025 with the first of two important studies.
The first — the “APPROACH” study — has enrolled 223 participants across 45 clinical sites in the U.S., with topline data expected in the fourth quarter of 2026.
The company is also in process on a second Phase 3 “EMBRACE” study that currently enrolling participants with moderate to severe major depressive disorder. The company has been granted approval to launch the study in Australia, Ireland, Poland, Greece, and the United Kingdom.
Patients who complete either of those two studies can roll over into “EXTEND,” an open-label extension designed to gather long-term durability data, which will measure how long the treatment’s benefits last after dosing.
Clinical drug trials and pharmaceutical development timelines are inherently unpredictable and subject to significant variability. Actual completion dates, regulatory approval timelines, and achievement of clinical milestones may differ—sometimes substantially—from any stated estimates, projections, forecasts, or expectations.
FDA Breakthrough Therapy Designation May Expedite the Process
Better yet, because of the clinical success Helus Pharma has had with its Phase 2 study of HLP003, it was granted “Breakthrough Therapy Designation” from the FDA, which acknowledges that the drug has the potential to meet a significant unmet medical need.
The designation may help expedite the regulatory review process. More on that in a moment.
How Ozempic Transformed Novo Nordisk
Let us give you a quick example:
You’ve no doubt heard of the drug Ozempic. Originally prescribed as a treatment for Type 2 diabetes, it was soon recognized for its ability to help patients lose weight.
And doctors began prescribing it “off-label” to their overweight patients — “off-label” meaning for a use other than what the FDA approved it for.
The drug’s surprising success soon sent sales soaring — largely because the number of obese people in the U.S. is nearly triple that of those suffering from Type 2 diabetes.
The result: Novo Nordisk — the company behind Ozempic — saw its market cap explode from $130 billion when the drug was launched to $232 billion today.
Ozempic accounted for nearly $5 billion of Novo Nordisk’s revenue in Q1 2025 alone!
The company was swimming in Ozempic cash. Some investors nearly doubled their money. And that’s on a $100 billion large-cap stock. Just imagine the return if Novo Nordisk had been a small-cap biotech like Helus Pharma (NASDAQ: HELP).*
Better yet, though HLP003 is designed to treat Major Depressive Disorder, its amazing impact on the brain means that it could potentially be prescribed for multiple off-label uses.
These could include issues often associated with depression — substance abuse disorders, smoking cessation, and even PTSD — making the potential for these new drugs even bigger… and the returns to
investors potentially even more lucrative.
No representation or warranty is made — express or implied — that results observed in one indication will translate to success, regulatory approval, or commercial viability in any other indication. Investors should not rely on data or outcomes from one indication when evaluating the potential of the drug for any other use.
Reason #2
Millions of people around the world are desperate for the relief Helus Pharma’s new drugs in development could offer
As you’ve seen, the numbers related to the global mental health crisis are absolutely terrifying:
Believe it or not, more than 332 million people worldwide suffer from MDD16, while 359 million suffer from anxiety disorders.17
Most everyone has a friend or family member that has struggled with mental health issues.
No wonder the research firm Global Market Insights reports that antidepressant sales hit $18.7 billion worldwide in 2024, and sales are expected to better than double by 2034 to $37.9 billion. 18
Most Antidepressants Are Less Effective
As many as 30-50% of patients don’t respond well to current drugs at all. 19
Let’s not forget the brutal side effects those drugs often bring, including sexual dysfunction, weight gain, nausea, insomnia, and fatigue, among others.
As an adjunctive treatment used to boost the efficacy of existing drugs, Helus Pharma (NASDAQ: HELP) clinical trials have shown limited side effects while helping many patients see improvement.20
Considering the success the company has had with its drug development thus far, we could see Helus Pharma (NASDAQ: HELP) snag a share of the market — if and when clinical trials are completed and FDA approvals granted.
Reason #3
RFK Jr. is leading the charge to open up the world to new therapies
It has been more than 50 years since the U.S. government outlawed natural compounds like psilocybin and DMT and banned medical research into their efficacy as pharmaceuticals.
But times have changed and attitudes have changed. And that has given treatments derived from these compounds a second chance to shine as they enjoy a medical renaissance of their own.
As you’ve seen, the U.S. and the U.K. are already allowing research at a number of respected universities and research institutions.
And the positive results this research is getting is creating new opportunities for even more research.
Better yet, President Trump’s Secretary of Health and Human Services, Robert F. Kennedy Jr., is running the show now and he has shown a remarkable openness to innovative new therapies similar to those being developed by Helus Pharma (NASDAQ: HELP).
On top of that, healthcare providers are on board.
A January 2025 Sermo survey of more than 430 mental healthcare providers worldwide found:21
- 79% noted rising patient interest in pharmaceutical drugs derived from natural compounds like psilocybin
- 89% recognize their therapeutic potential
- 94% are willing to integrate them into their treatment plans once they’re approved
Bottom line: If and when they’re approved, Helus Pharma (NASDAQ: HELP) proprietary treatments have the potential to be a game changer.
Reason #4
The FDA’s BTD Designation Is Expediting the path for potential New Therapies
As you know, the FDA holds immense power over pharmaceutical companies.
It serves as the gatekeeper for drug approval, marketing, and ongoing regulation in the United States — the world’s largest pharmaceutical market.
And even with Trump’s efforts at deregulation and Kennedy’s “Make America Healthy Again” push to speed up treatments that are shown to be safe, bringing a new drug to market is generally time-consuming, laborious and expensive …
… and so any drug that has the opportunity to leverage the BTD designation has the potential to expedite the review and approval process.
Companies applying for a BTD must meet some very specific criteria.
The drug must target a serious or life-threatening disease or condition where there’s a clear, unmet medical need — either no treatments exist, or current options are inadequate.
Plus, the drug’s early-stage clinical data must show that it offers substantial improvement over existing therapies. This could mean better efficacy, fewer side effects, or a novel mechanism of action.
Again, we believe HLP003 fits the bill.
How FDA Breakthrough Therapy Designation Can Help Helus Pharma
For Helus Pharma (NASDAQ: HELP), HLP003’s BTD may expedite the development pathway for HLP003. Among other things, Helus benefits from…
- Fast-Tracked Development: The FDA offers intensive guidance, often involving senior officials, to streamline clinical trials and reduce development timelines —
- Priority Review: BTD drugs get a faster review process (typically 6 months instead of 10) once a New Drug Application (NDA) or Biologics License Application (BLA) is submitted.
- Rolling Review: Companies can submit completed sections of their application as they go, rather than waiting to compile everything, potentially speeding up the overall approval process.
- Enhanced Collaboration: The FDA commits to working closely with the company, providing advice on trial design, endpoints, and data requirements to ensure efficiency and success.
We believe BTD signals to investors, researchers, and the medical community that HLP003 could be a game-changer. Of course, it doesn’t guarantee approval.
Clinical Trials to Billion-Dollar Paydays
For a small-cap company, this designation can elevate its profile within the biotech industry.
For example…
Breakthrough #1:
Luxturna by Spark Therapeutics
Spark Therapeutics, a small-cap biotech, saw its profile skyrocket after its drug Luxturna received Breakthrough Therapy Designation. The product went on to became the first FDA-approved gene therapy for a genetic disease in December 2017.
What happened to Spark Therapeutics?
The company’s valuation surged, and in 2019, Roche acquired Spark for an astonishing $4.3 billion — a massive leap from its earlier small-cap status.
Spark Therapeutics drug Luxturna received Breakthrough Therapy Designation, and after the drug was approved, the company’s stock more than doubled over the next 14 months, soaring from $48.94 to $114.50 when Roche acquired it — a gain of 133%.
Breakthrough #2:
Kanuma by Synageva BioPharma
In 2013, Synageva received BTD for sebelipase alfa (brand name Kanuma), a treatment for a rare condition called lysosomal acid lipase deficiency.
At the time, Synageva’s market cap was below $2 billion. The stock surged over 50% in the days following the announcement, and the company was later acquired by Alexion Pharmaceuticals for a massive $8.4 billion.
From the day Synageva BioPharma received Breakthrough Therapy Designation for its drug, Sebelipase Alfa — when the company’s stock price was $38.79 — to the day it was acquired by Alexion in a deal that valued the company at $230 a share, its stock was up 492%.
Breakthrough #3:
Firdapse by Catalyst Pharmaceutical
In August 2013, Catalyst Pharmaceutical secured a BTD for Firdapse (amifampridine) a drug for Lambert‑Eaton myasthenic syndrome — a rare autoimmune disorder that causes muscle weakness.
Its stock began moving immediately and over the next month more than doubled, rising 115%.
Today, this once-tiny biotech has a market cap of $294 billion — and its stock is up more than 1,554% since Firdapse was granted BTD. 22
HLP003’s Breakthrough Therapy Designation may have a similar impact on Helus Pharma (NASDAQ: HELP)… and it’s just one more reason why we are suggesting that our members begin their due diligence on this company right away.
A month and half after Catalyst Pharmaceuticals received Breakthrough Therapy Designation for its drug, Firdapse, its stock had more than doubled, shooting up 115%.
Reason #5
Helus Pharma is Building a Robust New Drug Pipeline
Despite all the progress we’ve already described, Helus Pharma (NASDAQ: HELP) isn’t resting on its laurels. It’s working day and night to isolate additional molecules for the creation of new drugs to treat a variety of mental health conditions.
As we mentioned, it has already filed 350 patent applications on the proprietary molecules it has developed. And more than 100 of those patents have been granted.
The Company is pursuing research on a number of fronts with the hope that its drugs will have an impact on a number of other conditions related to mental health.
These related disorders may include PTSD and substance use/addiction disorders.
While Helus Pharma (NASDAQ: HELP) is primarily focused on HLP003 and HLP004, it’s also devoting resources to developing a pipeline of drugs that could keep the Company growing for years to come.
Reason #6
Helus Pharma Boasts World Class Leadership
Over the years, we’ve seen plenty of companies with great ideas and all the advantages in the world fall into mediocrity because they didn’t have a strong leadership team with the experience and talent to take it the distance.
With that in mind, we always do a deep dive into a company’s leadership team before we ask our audience to take a look at its stock.
When it comes to Helus Pharma (NASDAQ: HELP), it boasts a strong executive line-up — a line up with the experience and talent we look for.
Reason #7
Big Pharma Faces a “Patent Cliff” that Could Spur a Small-Cap Buying
A number of big pharmaceutical companies are facing a “patent cliff” that could force them to take a revenue haircut measured in the hundreds of millions of dollars.
In fact, according to Evaluate, a data services company serving the pharmaceutical industry, a number of drugs that together generate more than $300 billion will lose their patent protection by 2030. 23
For example…
- Merck’s cancer drug Keytruda, generated $31.7 billion for the company in 2025 — nearly half of the company’s annual revenue. However, the patent on Keytruda expires in December 2028, leaving the company with a massive revenue hole to fill.24
- The patent on Johnson & Johnson’s cancer drug Darzalex expires in May 2029 — putting $17.8 billion of annual revenue in jeopardy.25
- Bristol Myers Squibb’s blood thinner Eliquis — which generates revenue of $14.3 billion a year — will see its patent expire in November of this year.26
We could go on and on with dozens of examples of drugs sitting at the edge of a patent cliff.
Of course, we don’t know whether or not a big pharmaceutical will make a play for Helus Pharma (NASDAQ: HELP), but with all it’s got going for it, it wouldn’t surprise us a bit.
When Big Pharma Acquires a Small Company, Early Investors Benefit
In 2021, Jazz Pharmaceuticals acquired GW Pharmaceuticals, handing nice profits to early investors who could have made 2,371% on their money.
Bristol-Myers Squibb’s October 2020 acquisition of MyoKardia helped early investors to a 2,150% windfall.
Now, don’t get us wrong. We would never suggest investing in a company based solely on its acquisition potential.
It’s always a possibility, but never something to count on. We like to look at it instead as potential icing on the cake.
Reason #8
A Surprising Number of Analysts See Good Times Ahead for Helus Pharma
As part of our research, we reviewed a number of analyst reports on Helus Pharma (NASDAQ: HELP). And they were uniformly positive about the prospects for Helus Pharma… citing the company’s exciting progress in clinical trials, and its future potential cash flow.
For example…
- Lucid Capital Markets is projecting that Helus could hit $57 a share by the end of 2026 — a 677% gain from its current share price. 29
- Alliance Global Partners forecasts that Helus could hit $30 a share between November 2026 and May 2027 — a 309% gain. 30
- H.C. Wainwright & Co. is projecting a $55 stock price — a 650% increase. 31
- Bloom Burton calls Helus “the most undervalued of mid-/late stage” companies in its niche and has set a target price of $47 per share — a 541% increase. 32
- Echoing Bloom Burton, Canaccord Genuity Capital Markets calls Helus “significantly undervalued” and projects it could soar to $45 a share — a 513% gain. 33
- Guggenheim recently increased its price target for Helus to $48 — a 554% gain. 34
In other words, we’re not alone in seeing great potential ahead for Helus Pharma (NASDAQ: HELP).
Bottom line:
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IMPORTANT NOTICE AND DISCLAIMER: All investments are subject to risk, which must be considered on an individual basis before making any investment decision. This paid advertisement includes a stock profile of Helus Pharma (NASDAQ: HELP). Rebel Investors Club is an investment newsletter being advertised herein. This paid advertisement is intended solely for information and educational purposes and is not to be construed under any circumstances as an offer to sell or a solicitation of an offer to purchase any securities. In an effort to enhance public awareness, Helus Pharma (NASDAQ: HELP) provided advertising agencies with a total budget of approximately $2,914,712 and is the sole source of funds to cover the costs associated with creating, printing and distribution of this advertisement. From that total budget, Moneta Advisory Partners, an affiliate of Rebel Investors Club was paid $500,000 as a research fee and for the production and placement of additional advertising media for this campaign. The advertising agencies will retain any excess sums after all expenses are paid. Rebel Investors Club may receive subscription revenue in the future from new subscribers as a result of this advertisement for its newsletter.
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