Moleculin Biotech MBRX Stock News

Moleculin Biotech Inc (NASDAQ: MBRX) is running for the top in the market this morning, trading on gains of over 30%. The gains came after the company said that it would seek the accelerated approval of Liposomal Annamycin for the treatment of AML. Here’s what’s going on:

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MBRX Stock Pops As Company Says It Will Seek Accelerated Approval

In the press release, Moleculin Biotech said that it will seek accelerated approval for Annamycin in both the United States and EU. These plans include meetings with both the FDA and EMA to disucss a potential single arm Phase 2 trial that would serve as the basis for accelerated approval.

The company said that the movement to Phase 2 studies will happen once it establishes a recommended Phase 2 dose. This process is in progress at the moment with the ongoing Phase 1 dose escalation trial at MBRX.

In the release, the company reminded investors that the treatment candidate has already been granted Fast Track Designation by the FDA. This is key as the FDA only provides this designation to drugs intended to treat serious conditions and that meet unmet medical needs.

In the most recent development update, the company said that a Phase 1 study in the United States recently met its primary objective of demonstrating safety of Annamycin at a dose that was cumulatively at or below the lifetime maximum anthracycline dose.

Of course, there is an ongoing study in Europe, where the treatment has demonstrated safety at escalating doses in AML patients.

In a statement, Walter Klemp, Chairman and CEO at MBRX, had the following to offer:We believe relying upon the European trial to establish an RP2D is the fastest and most efficient way to reach a pivotal Phase 2 trial. Recruitment in Europe has been faster than in the US and the trial is progressing well. The US Phase 1 trial was designed to demonstrate that Annamycin is indeed non-cardiotoxic when delivered to patients at or below the lifetime maximum anthracycline dose, and it has served that purpose. Beyond that, we have now treated 9 patients in the European trial above the lifetime maximum, also without any evidence of cardiotoxicity.

Why This Is So Exciting

The truth of the matter is that investing in clinical stage biotechnology companies is a waiting game. Investors wait for data that leads to them waiting for applications and waiting for approval.

However, Moleculin Biotech may have shortened that waiting period. The truth of the matter is that this candidate should qualify for accelerated approval if all goes well in trial. AML is a serious condition with high unmet medical need.

If MBRX can demonstrate safety and efficacy at a level of or better than standard care, with less toxicity, the FDA and EMA could push the drug through to approval in period of time that’s months, or even years, shorter than the general amount of time that this would take.

All in all, MBRX may find its way to commercialization relatively soon, and with an AML drug, that could mean that massive revenues are ahead.

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