Moleculin Biotech Inc. [MBRX] - Last Close $0.78
This micro-cap biotech firm is taking off after it announced a slew of regulatory approvals this morning.
The U.S. Food and Drug Administration approved the firm's request for a 'rare pediatric disease' designation for its experimental WP1066 therapy. With the designation in hand, Moleculin will receive a priority review voucher of new drug approval for three indications: diffuse intrinsic pontine glioma, medulloblastoma and atypical teratoid rhabdoid tumor.
Allow me to translate this into English. Moleculin has a new drug (WP1066) and they want it to get approved quickly. Now, they ask the FDA to give WP1066 a priority review because it could be useful as a treatment for rare diseases in children. The FDA says, "yes," and now Moleculin can move its drugs through the regulatory process quicker.
MBRX is up 47.4% on news of the FDA designation, and it's trading actively in the pre-market.
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