SPONSORED BY RAGING BULL AND DISSEMINATED ON BEHALF OF RELMADA THERAPEUTICS, INC.*

Good Morning Market Enthusiasts,

The most experienced market enthusiasts are always scanning for the moment when a massive clinical need meets a disruptive technological solution. 

Right now, the oncology space is witnessing exactly that. 

We are looking at a landscape where over 744,000 people in the United States alone are living with bladder cancer. 

The vast majority of these cases, roughly 80%, fall into the category of non-muscle invasive bladder cancer, or NMIBC. 

This is a market characterized by high recurrence rates, often between 50% and 80% over five years, and a treatment path that has remained grueling for decades.

For too long, the standard has involved invasive surgeries and frequent hospital visits that place a heavy burden on both the healthcare system and the people it serves. 

But a major shift is underway. Relmada Therapeutics, Inc. (Nasdaq: RLMD) is advancing a program that could fundamentally redefine how this disease is managed in a professional office setting.

(1)

The financial community is starting to take notice of this shift. 

Professional analysts currently maintain an average price target that represents a staggering upside of more than 150% from recent levels. 

This is not just a speculative hope. It is grounded in the hard data showing 92% complete response rates and a clear path to a potential NDA submission. 

Further supporting this outlook, technical indicators across both weekly and monthly timeframes are painting a consistent picture of serious potential. When professional analysis aligns so tightly with clinical success, it often signals a story that is ready to break out of the initial phase and into a full momentum run. 🏃

The Innovation Gap in NMIBC 💉 (1)(2)(3)(4)

The current journey for someone diagnosed with NMIBC is often a cycle of surgeries known as TURBT, followed by induction therapies that can be difficult to tolerate. 

Many have to face the prospect of a radical cystectomy, which is the complete removal of the bladder, when initial treatments fail. 

The market is desperate for bladder sparing options that actually work and do not require the intensity of an operating room.

The lead candidate from Relmada Therapeutics, Inc. (Nasdaq: RLMD), known as NDV-01, is a direct response to this crisis. 

It is a sustained release, intravesical formulation of two well known and powerful agents: gemcitabine and docetaxel. 

While medical professionals have used these agents for years, the delivery method has always been the bottleneck. Conventional methods require hours of clinical time and multiple administrations.

NDV-01 changes the math entirely. It is designed as a ready to use formulation that can be administered in a professional setting in less than 10 minutes. 

Once inside the bladder, it forms a soft matrix that gradually releases the medication over ten days. This ensures the area is exposed to the treatment for an extended period while minimizing the toxic effects on the rest of the body.

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Exceptional Data and De-Risked Milestones 🗻 (1)(2)(3)(4)

The momentum behind this program is driven by clinical results that are hard to ignore. 

In recent follow up data from an ongoing study, NDV-01 showed a 92% complete response rate at any time point in patients with high risk NMIBC. 

Even more impressive is its performance in the most difficult to treat subpopulation, which are those who are unresponsive to BCG, the traditional first line therapy. 

In that refractory group, the complete response rate was 91%.

Perhaps most importantly, the safety profile has remained favorable. To date, no patients have discontinued treatment due to adverse events, and there have been no reports of progression to more invasive disease or the need for a radical cystectomy among those treated. 

This level of efficacy combined with a manageable safety profile is exactly what the medical community has been waiting for.

The clinical results demonstrate that Relmada Therapeutics, Inc. (Nasdaq: RLMD) is not just developing another incremental improvement. NDV-01 is a potential best in class treatment that offers a bladder sparing, safe, and durable option. 

The data shows that 85% of patients maintained their complete response at the nine month mark, highlighting the durability of this novel delivery method. 17/20 evaluable patients had a complete response.

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Strategic Alignment and Regulatory Catalysts 🏁 (1)(2)(3)(4)

The roadmap for 2026 is now clearly defined. Relmada Therapeutics, Inc. (Nasdaq: RLMD) has secured alignment with the FDA on two distinct registrational paths, which significantly clarifies the route toward potential regulatory approval.

The first path is a single arm study focused on high risk, refractory patients who have very few options left. This is designed to be the fastest route to market. 

The second path targets intermediate risk patients in the adjuvant setting, which is a massive group where no therapies are currently approved. Both of these pivotal Phase 3 programs are expected to initiate in the first half of 2026.

The company is moving into this critical phase with a solid financial foundation. A recent $100M financing has extended their operational runway into 2028. 

This means they have the resources to not only drive these registrational studies for NDV-01 but also to advance their other pipeline asset, sepranolone, for rare conditions like Prader-Willi Syndrome.

Why Now ⏰💥

We are entering a period of high impact catalysts. 

The market is beginning to recognize the potential of a ready to use solution that can be delivered in a local clinic rather than a major surgical center. 

With twelve month data from the ongoing study expected in early 2026 and the start of two pivotal trials shortly after, the news flow is set to accelerate.

The medical community is already showing strong interest. The gemcitabine and docetaxel combination is already a preferred choice for many practicing urologists when first line treatments fail. 

By improving delivery and convenience, Relmada Therapeutics, Inc. (Nasdaq: RLMD)  with NDV-01 is positioned to address a portion of the ~$6.5B annual NMIBC cost burden in the U.S.

The transition from a clinical stage company to a registration track company is one of the most significant periods in a biotechnology narrative. 

For Relmada Therapeutics, Inc. (Nasdaq: RLMD), that transition is happening right now. The facts are on the table, the FDA has provided the map, and the clinical results are speaking for themselves. 💥 

Analysts are already looking at a 150%+ upside potential, and with technical indicators flashing green, the window for the initial story is closing as we head toward the 2026 milestones. (Potentially very soon!) (6)(7)(10)

To your success,

Max Masters

Co-founder, Market Tips Newsletter

Sources:

1. https://finance.yahoo.com/news/relmada-therapeutics-reports-third-quarter-210100552.html
2. https://finance.yahoo.com/news/relmada-therapeutics-announces-presentation-ndv-123000861.html
3. https://finance.yahoo.com/news/relmada-therapeutics-provides-regulatory-confirming-120000274.html
4. https://www.relmada.com/for-investors
5. https://www.relmada.com/
6. https://www.tipranks.com/stocks/rlmd/technical-analysis#
7. https://www.tipranks.com/stocks/rlmd#
8. https://finance.yahoo.com/quote/RLMD/
9. https://finance.yahoo.com/quote/RLMD/history/
10. https://finance.yahoo.com/quote/RLMD/analyst-insights/
 

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