Penny stock biotech Synthetic Biologics sees its 'breakthrough' status pulled as FDA ponders safety issues
A little under a year ago the penny stock of Synthetic Biologics $SYN gyrated higher on the news that its drug SYN-004 (ribaxamase) — designed to protect the gut microbiome from the havoc caused by some antibiotics and guard against Clostridium difficile infection — had won the FDA’s not-so-rare breakthrough therapy designation.
Today, though, after the biotech reviewed plans for an upcoming Phase III program, they followed up with the rare news that the FDA is dropping the BTD after regulators concluded that they couldn’t figure out why the drug arm experienced a higher rate of deaths in their Phase IIb trial.
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