By Colin Kellaher


Shares of Yumanity Therapeutics Inc. touched a fresh 52-week low Wednesday after the U.S. Food and Drug Administration placed a partial clinical hold on studies of the biopharmaceutical company's most advanced product candidate.

The Boston company said the hold suspends initiation of multiple-dose clinical trials of YTX-7739 in the progressive nervous-system disorder Parkinson's disease.

Yumanity said it received an e-mail notification of the partial hold from the FDA in response to an investigational new drug application the company submitted last month, adding that it expects more details from the agency within 30 days.

According to the FDA's website, subjects can't be given an investigational drug when a proposed study is placed on clinical hold. The agency lists several potential reasons for putting an investigational new drug application on hold, including the possibility that human subjects "would be exposed to an unreasonable and significant risk of illness or injury," or that the application doesn't contain enough information to assess the risks to subjects of the proposed studies.

Yumanity said the FDA hasn't halted all YTX-7739 clinical programming and is allowing a planned single-dose trial to proceed.

The company said the partial hold suspends initiation of multiple-dose trials, adding that it plans to working closely with the agency to address its concerns.

Yumanity shares were recently changing hands at $1.98, down 19%, after hitting a 52-week low of $1.80 early in the session.


Write to Colin Kellaher at


(END) Dow Jones Newswires

January 19, 2022 10:34 ET (15:34 GMT)

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