MBRX - Moleculin Biotech wins second FDA Fast Track Designation for Annamycin

Moleculin Biotech (MBRX) has climbed ~18.1% in the pre-market after announcing that the FDA has approved its request for Fast Track Designation for its experimental drug, Annamycin for the treatment of soft tissue sarcoma (“STS”) lung metastases.“We now have potential pathways for accelerated approval in two indications, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia," noted Walter Klemp, Moleculin's CEO.“We are now focused on initiating our internally funded clinical trial in the US, possibly prior to mid-year,” Mr. Klemp added.STS is the commonest form of sarcoma. An estimated 20% to 50% of STS sarcoma eventually metastasize to the lungs. If tumors cannot be removed surgically, the primary chemotherapy regimen is anthracycline doxorubicin (Adriamycin).Annamycin, an anthracycline has been shown to accumulate in the lungs in animal models at up to 30 times the level of doxorubicin.

For further details see:

Moleculin Biotech wins second FDA Fast Track Designation for Annamycin