Feb. 8 Quick Takes: FDA approves TG’s lymphoma therapy; plus uniQure, Astellas, BMS, Viiv, Avrobio and Veru
FDA approved Ukoniq umbralisib from TG Therapeutics Inc. (NASDAQ:TGTX) to treat relapsed or refractory marginal zone lymphoma following anti-CD20 treatment, or relapsed or refractory follicular lymphoma in a fourth-line setting. TG believes the once-daily oral TK inhibitor of CSNK1E and PI3Kδ could represent a safer option than other PI3K inhibitors. The company priced Ukoniq at $15,900 per 30-day supply, chief commercial officer Adam Waldman said on a conference call Monday.
No safety concerns for uniQure’s Huntington’s treatment
A Phase I/II trial of gene therapy AMT-130 from uniQure N.V. (NASDAQ:QURE) will proceed toward full enrollment of its first cohort around mid-year after a DSMB review identified no significant safety concerns from the cohort’s first four patients. Shares of uniQure rose 8% intraday Monday on the news. AMT-130 uses an adeno-associated viral serotype 5 (AAV5) vector carrying cassette-optimized synthetic microRNAs to silence the Huntingtin (HTT) gene...