Reworked Deal With Ipsen Gives GTx Extended Runway To Get Toremifene To Finish Line
This article was originally published in The Pink Sheet Daily
GTx needs to run a second Phase III trial of the prostate cancer drug due to a "complete response" letter from FDA.
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Having gone through the special protocol assessment process, the sponsor was surprised by the request for a second pivotal trial and another clinical trial on effects on cancer.
Biopharma is seeking a priority review for 80 mg toremifene, already marketed as Fareston at a 60 mg dose for breast cancer.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.