الخميس، 14 نوفمبر 2024

Moleculin Biotech (Nasdaq: MBRX) Triggers 17 Bullish Signals on Breaking News Announcement

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Market Crux Announces Moleculin Biotech, Inc. (Nasdaq: MBRX) as Its Next Potential Breakout Idea for Thursday!


Moleculin Biotech (Nasdaq: MBRX) Triggers 17 Bullish Signals on Breaking News Announcement!


Moleculin Biotech, Inc. (Nasdaq: MBRX) comes backed by several potential catalysts including:


Ultra Low Float: With fewer than 3M shares in the public float, Moleculin Biotech, Inc. (Nasdaq: MBRX) has the potential to see significant swings if demand begins to shift.


Technical Indicators: Currently trending above key moving averages (5-Day: $2.47, 20-Day: $2.52, and 50-Day: $2.49) with the 100-Day at $2.79 and 200-Day at $4.40.


Analyst Coverage: Benzinga reports Maxim Group’s recent $8 target for Moleculin Biotech, Inc. (Nasdaq: MBRX), suggesting a potential upside of over 218% from today’s opening.


Upcoming Phase 3 Trial for AML: Moleculin Biotech, Inc. (Nasdaq: MBRX)’s Phase 3 MIRACLE trial for AML treatment is set to begin in early 2025, marking a critical step for its lead therapy, Annamycin.


Breakthrough Therapy with Annamycin: Annamycin is designed to avoid cardiotoxicity and overcome resistance, with Fast Track and Orphan Designations highlighting its potential in AML and STS lung metastases.


Consider taking a look at Moleculin Biotech, Inc. (Nasdaq: MBRX) before this morning's opening bell...







November 14, 2024



Dear Reader,



Moleculin Biotech (Nasdaq: MBRX) triggers 17 Bullish Signals on TradingView’s technical analysis tool using the 1 hour time-frame.


Moleculin Biotech (Nasdaq: MBRX) moved approximately 19% earlier today, reaching $2.99 from yesterday’s $2.51 close, surpassing several key moving averages including: 


5-Day : 2.56

20-Day: 2.53

50-Day: 2.50

100-Day: 2.78


With its 200-Day moving average at 4.38, Moleculin Biotech (Nasdaq: MBRX) is one company to keep an eye on.


This comes on the heels of Moleculin Biotech (Nasdaq: MBRX)’s breaking news announcement.



Moleculin Biotech (Nasdaq: MBRX) just fast-tracked its MIRACLE Phase 3 trial, bumping up the unblinded data readout to the second half of 2025. 


This aggressive protocol amendment, already in review by the FDA and IRB, means Moleculin will reveal critical efficacy and safety insights on the AnnAraC combo for AML sooner than expected—potentially a game-changer for partnering and progress toward approval. 


With the first patient set to be dosed early 2025, Moleculin Biotech (Nasdaq: MBRX) is on a high-stakes path that could redefine the landscape for relapsed or refractory AML treatment.

See the full story here.

If you missed our earlier coverage on Moleculin Biotech, Inc. (Nasdaq: MBRX), please keep reading below.


Our latest spotlight is on Moleculin Biotech, Inc. (Nasdaq: MBRX), a company with less than 3M shares available in the public float and currently trending above several key moving averages:


  • 5-Day: $2.47
  • 20-Day: $2.52
  • 50-Day: $2.49


With its 100-Day MA at $2.79 and 200-Day MA at $4.40, Moleculin Biotech, Inc. (Nasdaq: MBRX) is one little-known biotech to keep an eye on.


Benzinga also reports that Maxim Group has recently set a target at $8, which suggests over a 218% potential upside from today’s $2.51 opening.



It’s important to remember that companies with low floats can have a high potential to make significant swings if demand begins to shift.

Keep reading to see why Moleculin Biotech, Inc. (Nasdaq: MBRX) will be #1 on this morning’s watchlist…


Moleculin Biotech, Inc. (Nasdaq: MBRX) is reshaping the biotech landscape with a powerful focus on hard-to-treat cancers and viruses. 


As a Phase 3 clinical-stage company, Moleculin’s pioneering work could provide critical breakthroughs for conditions where patients have limited options. 


With Annamycin, a next-generation anthracycline, Moleculin aims to address two of the biggest challenges in cancer therapy: resistance to treatment and cardiotoxicity. 


Here’s an in-depth look at Moleculin’s approach, ambitions, and recent achievements that underscore its game-changing potential.


Annamycin: A Game-Changer in Cancer Therapy


At the heart of Moleculin Biotech, Inc. (Nasdaq: MBRX)’s pipeline is Annamycin, a next-generation anthracycline designed to overcome the drawbacks of conventional cancer therapeutics. 


Traditional anthracyclines, while effective, have severe cardiotoxic side effects, often limiting their use and putting patients at risk of serious cardiac events. 


Annamycin, however, has shown zero cardiotoxicity in clinical trials and is specifically engineered to bypass multi-dr-ug resistance, a common issue that makes many cancer therapies less effective over time.


Fast Track and Orphan Designations from the FDA for Annamycin in AML, as well as Orphan Designation for STS lung metastases, highlight its potential to address significant unmet needs and fast-track its journey to market.


The MIRACLE Trial: A Major Step for AML

In early 2025, Moleculin Biotech, Inc. (Nasdaq: MBRX) will launch the MIRACLE trial (Moleculin R/R AML AnnAraC Clinical Evaluation), an adaptive Phase 3 trial that represents a major leap forward for Annamycin’s development. 


This pivotal, global trial will evaluate Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML), a cancer known for high relapse rates and few effective treatment options.


The MIRACLE trial’s adaptive design allows Moleculin to test and identify the optimum dose midway through the trial, increasing both efficacy and safety. 


If successful, Moleculin Biotech, Inc. (Nasdaq: MBRX) is prepared to submit a rolling New Application (NDA) with the FDA by late 2028, positioning Annamycin for accelerated approval.


Key Milestones for the MIRACLE AML Development Program:


  • 4Q 2024: Site contracting and Institutional Review Board (IRB) approval for MIRACLE trial
  • 1Q 2025: First patient dosing in the MIRACLE trial
  • 4Q 2025: Preliminary efficacy update following enrollment of 45 patients
  • 2H 2026: Optimum dose selection for continuation of the MIRACLE trial


Expanding Annamycin’s Reach: Tackling STS Lung Metastases


Moleculin’s vision for Annamycin extends beyond AML. 


The Company recently completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 trial evaluating Annamycin for soft tissue sarcoma (STS) lung metastases, a condition with few effective treatments. 


Moleculin expects to release the final data in early 2025, a significant milestone that could lead to a new phase of development for this challenging cancer type.


Key Milestones for Annamycin STS Lung Metastases

 Development Program:


  • 2025: Final MB-107 data readout for STS lung metastases
  • 2025: Determine next steps for a pivotal program in STS


Capital Backing and Strategic Expertise: Moleculin’s 

Blueprint for Success


With a ca-sh balance of $9.4M reported for Q3 2024 and an additional $11M available through milestone-linked warrants, Moleculin has a strong financial foundation to meet its clinical milestones. 


Additionally, the recent appointment of Dr. Daniel D. Von Hoff, a leading pancreatic cancer expert, to its Scientific Advisory Board brings world-class expertise to the Company’s pipeline.


Moleculin Biotech, Inc. (Nasdaq: MBRX)’s partnerships with leading institutions, including MD Anderson Cancer Center, support its robust research and development strategy. 


This combination of financial and intellectual resources positions Moleculin to drive forward its ambitious clinical programs and lay the foundation for substantial growth.

Recent Developments 


MIRACLE Phase 3 Trial for AML Set to Begin in 2025


Moleculin’s MIRACLE trial is expected to begin dosing patients in early 2025. This Phase 3 trial represents a pivotal step toward an accelerated approval pathway, following positive Phase 1B/2 data and extensive FDA consultation.


Strong Phase 1B/2 AML Results


Moleculin Biotech, Inc. (Nasdaq: MBRX) recently reported that the median durability of complete response composite (CRc) in its MB-106 AML clinical trial exceeded eight months, underscoring Annamycin’s potential in providing durable responses for AML patients with limited options.


Addition of Top Cancer Expert to Scientific Advisory Board


Moleculin Biotech, Inc. (Nasdaq: MBRX) appointed Dr. Daniel D. Von Hoff to its Scientific Advisory Board, reinforcing its scientific leadership and supporting Annamycin’s continued development.


Highlights from AML Key Opinion Leader (KOL) Event


Moleculin Biotech, Inc. (Nasdaq: MBRX) recently hosted a virtual KOL event featuring AML experts who discussed Annamycin’s transformative potential and Moleculin’s commitment to advancing safe, effective AML treatments.


Exciting Data on STS Lung Metastases


At the IASLC 2024 World Conference on Lung Cancer, Moleculin presented data showing Annamycin’s potential in targeting lung metastases from STS, highlighting its versatility beyond AML.


Highlights


With a solid ca-sh position and additional potential funding from warrants, Moleculin Biotech, Inc. (Nasdaq: MBRX)’s fiscal strength supports its ambitious clinical milestones through early 2025.


The Road Ahead: Moleculin’s Vision for Transformative Cancer Care


Moleculin’s innovative approach and impressive clinical achievements make it one of the most promising biotech companies today. 


The upcoming MIRACLE trial is not only a significant step forward for Annamycin but also a pivotal moment for patients with few other options. 


With a robust pipeline, financial stability, and the backing of top-tier scientific expertise, Moleculin Biotech, Inc. (Nasdaq: MBRX) is aiming to redefine cancer treatment and deliver groundbreaking results in 2025 and beyond. 


This is more than just a company to watch; it’s a driving force in the future of oncology.


Here’s 5 reasons why Moleculin Biotech, Inc. (Nasdaq: MBRX) will be at the top of our watchlist this morning…


1. Ultra Low Float: With fewer than 3M shares available in its public float, Moleculin Biotech, Inc. (Nasdaq: MBRX) has the potential for significant swings if demand begins to shift.


2. Technical Indicators: Moleculin Biotech, Inc. (Nasdaq: MBRX) is currently trending above several key moving averages (5-Day: $2.47, 20-Day: $2.52, and 50-Day: $2.49). With the 100-Day at $2.79 and 200-Day at $4.40, there’s reason to keep an eye on this one.


3. Analyst Coverage: According to Benzinga, Maxim Group has recently set a target of $8 for Moleculin Biotech, Inc. (Nasdaq: MBRX) , which suggests a potential upside of over 218% from yesterday’s opening.


4. Upcoming Phase 3 Trial for AML: Moleculin Biotech, Inc. (Nasdaq: MBRX)’s highly anticipated Phase 3 MIRACLE trial, aimed at treating acute myeloid leukemia (AML), is scheduled to begin in early 2025. This could be a pivotal moment for the company’s lead therapy, Annamycin, in tackling a critical cancer need.


5. Breakthrough Therapy with Annamycin: Annamycin, Moleculin Biotech, Inc. (Nasdaq: MBRX)’s leading candidate, is engineered to avoid cardiotoxicity and overcome multi-dr-ug resistance—two serious drawbacks of traditional therapies. Fast Track and Orphan Designations for Annamycin reflect its potential to address substantial unmet needs in AML and STS lung metastases.


Consider putting Moleculin Biotech, Inc. (Nasdaq: MBRX) on 

your radar this week..


With a float of under 3M shares, and trending above several key moving averages, Moleculin Biotech, Inc. (Nasdaq: MBRX) has positioned itself as one little-known company to keep an eye on.


Maxim Group’s recent $8 target suggests a potential upside of over 218% from this morning’s opening. 


Moleculin Biotech, Inc. (Nasdaq: MBRX) is gearing up to launch its Phase 3 MIRACLE trial in early 2025, focusing on Annamycin, a therapy specifically engineered to overcome two critical limitations in traditional cancer treatments: cardiotoxicity and resistance. 


This innovative approach brings renewed hope to patients in need. 


Supported by the FDA’s Fast Track and Orphan Designations, Moleculin Biotech, Inc. (Nasdaq: MBRX) is set to make headlines in the biotech sector as it advances solutions for hard-to-treat cancers.


Moleculin Biotech, Inc. (Nasdaq: MBRX) will be #1 on our watchlist early this morning.


I’ll follow up with you shortly.

Sincerely,


Gary Silver

Managing Editor,

MarketCrux

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