Summary by Futu AI
On March 15, 2024, 60 Degrees Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration (FDA) has delayed its response to the company's Tafenoquine-Babesiosis Trial Protocol Submission. The FDA's feedback, initially expected in March 2024, is now anticipated in April 2024. Despite the delay, 60 Degrees Pharmaceuticals continues to prepare for the trial's start date on June 1, 2024. Tafenoquine, the active ingredient in question, is an anti-malarial drug approved by the FDA in 2018 for malaria prophylaxis in adults. The drug is currently available in the United States and Australia under the brand names ARAKODA® and KODATEF®, respectively. The company, which specializes in developing treatments for infectious diseases, has been supported by the United States Department of Defense and private investors, including Knight Therapeutics Inc. The press release also included cautionary notes regarding forward-looking statements, highlighting risks and uncertainties that could affect the company's future results and financial condition.