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BioWorld - Sunday, March 22, 2026
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Home » PPAR for the course, hold to persist while Gemphire adds tox findings per FDA
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PPAR for the course, hold to persist while Gemphire adds tox findings per FDA

Aug. 8, 2018
By Randy Osborne
Pressed for details about timing of next steps with gemcabene in dyslipidemia – still on partial clinical hold by the FDA – Gemphire Therapeutics Inc. CEO Steve Gullans said the regulators' demand for more toxicology data is "very recent news, so we haven't had time, working with all the third-party vendors that will be involved, to figure out the exact timeline. We would love to get the 13-week study up and running immediately, but these PPAR alpha knockout mice require some work to get a breeding colony up and rolling. That's why we're targeting the end of the year, beginning of next year. Right now, it's the best estimate we're operating from. That's in keeping with what we've seen in prior work we've done around breeding colonies. Roughly speaking, we would see a nine to 12-month delay over where we were before" the agency made known its decree.
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