14-year-old partial hold comes back to haunt Gemphire, battering shares and wrecking timelines
A 14-year-old partial clinical hold on Gemphire’s lead — and only — drug just came back to bite the biotech today, and the stock market reaction quickly carved out half of its market cap in savage retribution.
Frequently overlooked in the roller coaster ride investors have had since the biotech went public two years ago, with plans to advance the old Pfizer drug for NASH and cardio purposes, the FDA clamped a partial clinical hold on the drug in 2004, preventing any studies using the drug in patients for more than 6 months because regulators determined that the therapy had potential toxicity issues linked with the PPAR drug class.
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