Yumanity Therapeutics Shares Tumble on Partial FDA Study Hold
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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
January 19, 2022 10:34 ET (15:34 GMT)
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