60 Degrees Pharma Shares Rise 18% After Type C Meeting With FDA
22 January 2024 - 3:41PM
Dow Jones News
By Chris Wack
60 Degrees Pharmaceuticals shares were up 18% to 74 cents after
the company said it will move forward with a pivotal clinical study
of tafenoquine in hospitalized babesiosis patients in the U.S.
following a Type C meeting with the Food and Drug
Administration.
The stock hit its 52-week low of 51 cents on Nov. 20, and closed
down 15% on Friday.
In advance of the meeting, 60 Degrees provided to the FDA an
information package that included a presentation of the unmet
medical need for a new therapeutic for hospitalized babesiosis
patients, as well as a detailed outline of the proposed study
protocol.
The FDA indicated in remarks during the meeting that the
proposed study could be sufficient for regulatory approval,
provided the company uses a clinical endpoint rather than a
surrogate marker.
60 Degrees is now revising its study protocol in light of that
feedback, with the goal of initiating patient enrollment in the
summer of 2024.
Tafenoquine is approved for malaria prophylaxis in patients 18
years and older in the U.S. under the product name Arakoda.
Tafenoquine hasn't been proven to be effective for treatment or
prevention of babesiosis and isn't approved by the FDA for such an
indication.
"Our recent Type C meeting with the FDA led to mutual alignment
with respect to the design of a development plan to evaluate the
Arakoda regimen of tafenoquine for treating people who are
hospitalized with babesiosis," said Geoff Dow, chief executive of
60 Degrees Pharmaceuticals.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 22, 2024 10:26 ET (15:26 GMT)
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