Selasa, 09 Desember 2025

It’s Almost Time: See Why (MBRX) Just Jumped to the Top of Our Watchlist

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Jeff Ackerman Just Announced Moleculin Biotech, Inc. (Nasdaq: MBRX) Is Back At The Top Of Tuesday Morning's Watchlist

Full Coverage Starts This Morning—Tuesday, December 9, 2025

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Take A Look At (MBRX) While It's Still Early…

December 9, 2025

It's Almost Time | See Why (MBRX) Just Jumped to the Top of Our Watchlist

Dear Reader,

An under-the-radar company is making significant strides in developing next-generation therapies designed to tackle some of the most aggressive and overlooked cancers.

Through a growing lineup of advanced candidates and strategic collaborations with leading research institutions, this organization is redefining what's possible in targeted cancer treatment.

Early data highlights strong potential across multiple indications, supported by regulatory designations that accelerate development.

As it advances toward key milestones, this company is rapidly gaining attention within the scientific community.

Which is why Moleculin Biotech, Inc. (Nasdaq: MBRX) is topping our watchlist this morning—Tuesday, December 9, 2025.

But keep in mind, (MBRX) has less than 3M shares listed in its public float, according to MarketWatch.

When companies have small floats like this, the potential exists for big moves if demand begins to shift.

Take a look at why (MBRX) just landed back on our radar…

Moleculin Biotech, Inc. (Nasdaq: MBRX)

(MBRX) is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and vi-rus-es.

Annamycin: Next Generation Non-Cardiotoxic(1) and Organotropic Anthracycline

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Annamycin is a next-generation anthracycline being evaluated in the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia (AML).

If successful, Annamycin has the potential to transform the standard of care for 2nd line AML. Annamycin is also in development for the treatment of soft tissue sarcoma (STS).

The company believes anthracyclines are among the most important treatments for AML and advanced STS.

However, cardiotoxicity issues limit their effectiveness with life-time maximum dosing set by the US FDA.

Annamycin has demonstrated in multiple clinical trials a lack of cardiotoxicity(1), allowing Moleculin to exceed the currently set maximum lifetime dosing for an anthracycline and potentially realizing the full therapeutic potential of anthracyclines to treat serious, hard-to-treat cancers.

In addition to demonstrating a lack of cardiotoxicity(1) in patients treated in Moleculin trials to date, Annamycin is demonstrating to have superior efficacy in 2nd line AML compared to currently available treatments.

Key Highlights:

  • Potential to be safer and more effective than current prescribed anthracyclines
  • Non-cardiotoxic1 and avoids cross resistance with doxorubicin, cytarabine (Ara-C) and Venetoclax
  • Delivers more than double the Complete Response (CR) rate of any approved treatment for relapsed/refractory acute myeloid leukemia
  • US FDA Orphan Drug Designation for STS Lung Mets and AML
  • U.S. FDA Fast Track Status for STS Lung Mets

MIRACLE: Pivotal, Adaptive Phase 3 Trial in Acute Myeloid Leukemia

The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, is expected to initially utilize an adaptive design whereby the first 75 to 90 subjects will be randomized in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, such doses were specifically recommended by the FDA in the Company's end of Phase 1B/2 meeting.

The amended protocol will allow for the unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at 45 subjects. This early unblinding will yield 30 subjects with Annamycin and HiDAC and 15 subjects with just HiDAC. The Company expects to reach 45 subjects in the second half of 2025, in addition to the planned unblinding expected in 2026 of the next 30–45 subjects.

For Part B of the trial, approximately 244 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose will be based on overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA's Project Optimus initiative. This increase from 240 to 244 subjects represents the statistical "cost" of the additional unblinding.

The amended protocol is currently being reviewed by the Institutional Review Board (IRB). Once approved, the amended protocol will be filed with the amendment for the Company's Initial New Dr-ug (IND) application in the US with the FDA.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

Potential Accelerated Timeline

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Find Key Sources And More: MBRX Website. MBRX Presentation.

5 Reasons Why (Nasdaq: MBRX) Is Topping Our Watchlist

This Morning—Tuesday, December 9, 2025

#1. A Low Float Environment May Create A Situation For Significant Volatility Potential.

With less than 3M shares in its float, volatility potential could be heightened for (MBRX) at the drop of a hat.

#2. Moleculin's Accelerated "MIRACLE" Trial Signals Promising Momentum In Global AML Research.

(MBRX) recently announced strong progress in its pivotal MIRACLE Phase 3 trial evaluating Annamycin for relapsed or refractory acute myeloid leukemia (AML), with 60% of the first 45 targeted subjects already consented.

Despite minor site delays in Europe, recruitment and enthusiasm remain strong across five different countries. Completion of treatment for the first 45 patients is expected in Q1 2026, followed by initial unblinded data. Blinded response activity is tracking as anticipated.

#3. Moleculin Expands Strategic Collaboration Advancing Annamycin Research For Pancreatic Cancer Treatment Innovation.

(MBRX) announced a new research collaboration with the University of North Carolina at Chapel Hill to evaluate Annamycin for pancreatic cancer.

#4. Moleculin Expands Collaborative Research Advancing Annamycin Development In Pancreatic Cancer Treatment.

(MBRX) announced a partnership with Atlantic Health to launch an investigator-initiated Phase 1B/2 study of Annamycin for third-line pancreatic cancer treatment.

#5. A Potential Healthy Reversal Could Be Nearing As Technicals Appear Oversold For MBRX.

A technical analysis reveals (MBRX) has several oversold indicators, including RSI levels below 33% and a 14-Day Raw Stochastic below 25%.

These technical levels suggest a profile that may be currently undervalued.

Take A Look At (MBRX) While It's Still Early…

With fewer than 3M shares in its float, (MBRX) sits in an environment where momentum can shift quickly, especially as attention builds around its clinical progress.

The company's accelerated MIRACLE Phase 3 trial continues to advance, with enrollment pacing ahead of expectations across multiple international sites.

Beyond AML, (MBRX) is broadening its scientific footprint through new collaborations focused on pancreatic cancer—both with the University of North Carolina at Chapel Hill and Atlantic Health—signaling a clear expansion of Annamycin's potential reach.

And from a technical standpoint, oversold indicators point to a profile that may be positioned for a healthier move if sentiment begins to shift.

We have all eyes on (MBRX) this morning—Tuesday, December 9, 2025.

Take a look at (MBRX) while it's still early.

Also, keep a lookout for my next update, it could be hitting any moment.

Sincerely,

Jeff Ackerman
Managing Editor
Stock News Trends

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