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GTx Muscle Wasting Drug Fails, But Data Offer Possible New Path

 
• By Shirley Haley

Enobosarm failed under FDA analysis plan but met European requirements in NSCLC muscle wasting trials, while a potential survival signal may lead to a positive change of plans in the U.S.

GTx Inc. may try to recharacterize its muscle wasting drug enobosarm after top-line data from a pair of Phase III trials linked the nonsteroidal selective androgen receptor modulator (SARM) with a potential positive impact on survival, Mitchell Steiner, chairman and CEO, said during an Aug. 19 call with analysts.

In top-line data from the POWER1 and POWER2 trials, enobosarm, which the company plans to market as Ostarine, failed to meet the co-primary endpoints of improved lean body mass and...

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