PBT2 regulatory update

Prana said FDA granted Orphan Drug designation to PBT2 to treat Huntington's disease (HD). In February, the company reported that 100 and 250 mg doses of oral PBT2 once daily for 26 weeks met the primary safety endpoint and were well tolerated in the U.S. and Australian Phase IIa Reach2HD trial in 109 patients with early to mid-stage HD (see BioCentury, Feb. 24). ...