IKT - Inhibikase craters 36% as FDA places clinical hold on IkT-148009 201 programs

• Inhibikase Therapeutics ( NASDAQ: IKT ) stock fell ~ 36% on Monday after the company said that the U.S. Food and Drug Administration (FDA) issued a clinical hold on its IkT-148009 201 program in Parkinson's disease and the use of IkT-148009 in Multiple Systems Atrophy (MSA).
• The company said the FDA reviewed its investigational new drug (IND) application seeking to start a trial of IkT-148009 to treat MSA.
• "We have not seen any serious adverse events in the ongoing 201 trial and we remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases," said Inhibikase President and CEO Milton Werner.
• Werner added that given the safety, tolerability and pharmacokinetics data in trials of IkT-148009 to date, the company is working with the FDA to understand the agency's concerns and to resolve them as soon as possible.
• Inhibikase noted that the FDA will provide an official clinical hold letter within 30 days.
• In June, the company said it was starting a phase 2a trial of IkT-148009 to treat Parkinson's disease, following review of the study protocol and phase 1/1b data by the FDA.

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