Moleculin Biotech (MBRX) thinks the Food and Drug Administration is going to greenlight their Phase 2 trials for the company's primary drug candidate as early as January.
The company went public last June in a $9.2 million IPO that was something of a hybrid between a traditional offering and a Reg A+ offering, relying on Facebook to draw the attention of investors to road shows in such far flung locales as Charlotte N.C. and Austin, Texas.
Shares in the pre-clinical pharma company focused on anti-cancer drug development debuted June 2 on NASDAQ at $6 and traded up 25% to a close of $8. Shares opened Nov. 18 at $3.13 but then traded down 5% to $2.87.
Shares have climbed as high as $9.58 this year and the low end price was $2.34.
The company reported Nov. 17 that it had received positive verbal guidance from the FDA that it can include prior established data in its Investigational New Drug Application for Annamycin, drug to treat patients with acute myeloid leukemia (AML). Annamycin is an anthracycline, part of the traditional relapsed or refractory acute AML treatment when paired with chemotherapeutic drugs.
Anthracyclines like doxorubicin are cardiotoxic and can damage the heart, meaning that dosages must be limited. Moreover, tumors can either be resistant or develop a resistance to current anthracyclines limiting the effectiveness of the therapy.
So far, Annamycin has been tested in six trials and 114 patients without showing any toxicity. Two of those trials were focused on leukemia. The drug has also demonstrated efficacy and in some patients cleared the leukemic blasts so that the patients qualified for bone marrow transplants.