Grab Sources And More: MBRX Website. MBRX Presentation. -----
And as I mentioned above, (Nasdaq: MBRX) has several potential catalysts that could provide it with some breakout buzz. Look at these:
#1. MBRX Potential Catalyst - A Low Float Could Create A Volatile Environment In Moments.
According to the Yahoo Finance website, MBRX has a fairly low float.
In fact, the website reports this profile to have approximately 29.42Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility potential.
If the company provides more positive company news in the 2nd half of 2025, could it create a near term spark? -----
#2. MBRX Potential Catalyst - Breaking News Monday: First EU Patient Dosed In Pivotal Phase 3 MIRACLE Trial.
Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia
Spain site opens with two R/R AML subjects enrolled; One treated
On track to recruit 45 subjects in 4Q25 for initial data unblinding
HOUSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that it has enrolled the first two subjects, and treated one, in the European Union (EU) in its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, the EU, and other parts of Europe.
“We now have active sites recruiting in the US, Spain, Ukraine, Georgia, and Romania with more sites expected to come online by the end of September. For our first site in Spain to have opened up with two subjects enrolled, we believe, indicates the unmet need in treating second line R/R AML,” said Walter Klemp, Chairman and CEO of Moleculin. “All of this, importantly, supports our goal to recruit the first 45 subjects for Part A before the end of 2025 for which efficacy and safety will be unblinded.”
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Read the full article here. -----
#3. MBRX Potential Catalyst - "Exciting Data" Continues To Roll In With Positive AML Overall Survival Update.
Moleculin Issues New Positive AML Overall Survival Data
Median Overall Survival (OS) of 15 months for subjects with complete remission (n=8)
Median OS of 2nd Line efficacy evaluable population of 12 months (n=9)
Median OS of Intent to Treat population (1L-7L) of 9 months (n=22)
OS demonstrated by Annamycin in the MB-106 trial is significantly above industry expectations for relapsed AML (4-6 months)
Clinical study report anticipated in Q1 2026
Company continues to execute Part A of the pivotal MIRACLE Phase 3 trial
HOUSTON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), ..., today announced the completion of its Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML). Database lock for the trial is expected by the end of September, with the final clinical study report (CSR) projected to be published in early Q1 2026.
In total, 22 subjects were enrolled in the trial, with all subjects (1L-7L) who received AnnAraC per protocol having completed their efficacy evaluations (n=20). The updated overall survival (OS) data reveal the following:
- Median OS for Complete Remissions (CR): 15 months (n=8) with 4 subjects alive at study close
- Median OS for the intent to treat (ITT) Population (1L-7L): 9 months (n=22; 13 subjects experienced an event, 9 subjects censored)
- Median OS for 2L Efficacy Evaluable Population: 12 months (n=9)
“Industry publications1 note that the typical OS for relapsed AML patients is roughly 4-6 months, these results highlight a remarkable improvement, exceeding expectations by 30% or more,” said Walter Klemp, Chairman and CEO of Moleculin Biotech.
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“We are glad to finally be in a position to close out our last Phase 2 AML trial, MB-106 by having completed follow-up on all subjects – some with durable CRs continuing – with database lock expected by the end of next month. While still technically preliminary, we are extremely pleased with the results of the MB-106 trial and look forward to the final CSR. These 2L data formed the basis for the design of the Phase 2B/3 pivotal MIRACLE trial with which we aim to gain eventual approval of Annamycin to serve the unmet need in 2L AML,” added Walter Klemp, Chairman and CEO of Moleculin. “We continue to see meaningful, positive trends across all data points, particularly in overall survival and durability. Of note, an 80+ yr old subject who achieved a CR with one cycle of Annamycin and then received two maintenance cycles of Annamycin finally relapsed after 600+ days. He then received a fourth round of Annamycin under compassionate use and is now back in remission. These data are very exciting and continue to give us hope that Annamycin has the potential to address the significant unmet need for safe and effective therapies for R/R AML. We also need to reemphasize that we have not seen any cardiotoxicity in any of the subjects to date, a key aspect of Annamycin.”
“We can now also report that 50% of subjects achieving CR moved on to a curative bone marrow transplant, which is the most sought-after goal of any induction therapy in AML,” Mr. Klemp continued. “The results we have seen in 2L patients are better than any drug ever approved for second line AML and more than double the average for the last five drugs approved for 2L use.”
“Looking ahead, we are focused on driving Part A of our Phase 3 MIRACLE trial forward and remain on track recruit the first 45 enrolled patients before the end of this year on which safety and efficacy will be unblinded. The final data from MB-106, coupled with the expected data from the MIRACLE trial will be invaluable as we continue to unlock the full potential of Annamycin for the treatment of AML,” concluded Mr. Klemp.
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Read the full article here. -----
#4. MBRX Potential Catalyst - Multiple Analyst Targets Point To Quadruple-Digit Potential Upside For MBRX!
Check out what we found over at TipRanks: |