There’s been a considerable amount of chatter in recent days over whether or not Kite $KITE can expect to win an accelerated FDA approval for its leading CAR-T drug based on 3 months of response data. But the biotech is touting its case at ESMO this weekend, hitting hard on positive 12-month results from a tiny study to back up their case that KTE-C19 has a durable impact on patients. The complete remission rate for the drug is 43% through a full year of treatment, says Kite. And they trumpeted the number as cancer specialists lined up for the big ESMO meeting. “These data complement our recently reported interim topline results from ZUMA-1 Phase 2 and support the potential for KTE-C19 to be a breakthrough therapy for chemorefractory, aggressive NHL,” said David Chang, Kite’s research chief, in a statement. “We are encouraged that the complete remission rate of 43 percent in the Phase 1 portion of the study continues through month 12 and look forward to reporting additional data on the durability of response to KTE-C19 from the Phase 2 portion of ZUMA-1 in 2017.”
Gene editing contender CRISPR Therapeutics has set the terms on its IPO, looking to sell 4.7 million shares at $15 to $17 each on the way to raising about $75 million with a market valuation of $668 million.
Bernard “Joe” Lavins Jr., the head of clinical research and a key figure in the development of Linzess, died tragically in a bike accident. His bike collided with an 18-wheeler on Wednesday. He was 60.
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