60 Degrees Pharma Withdraws COVID Phase IIB IND, Will Resubmit Pending Assessment of Ability to Meet FDA Requirements
60 Degrees Pharmaceuticals, Inc. (SXTP)
Company Research
Source: GlobeNewswire
Prompted by advice from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of 60 Degrees Pharmaceuticals, has withdrawn its IND for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19; Company plans to resubmit a revised IND later in 2023, pending a feasibility assessment60P has paused further study start-up preparations related to ACLR8-LR, decreasing the Company’s short-term burn rate60P will continue planned efforts to expand its malaria business and prepare an IND for tafenoquine for babesiosis to be submitted to FDA WASHINGTON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (“60P”) (NASDAQ: SXTP), specialists in developing and marketing medicines for infectious diseases, today announced that 60P Australia Pty Ltd, a majority-owned subsidiary of 60P, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19, and intends to sub
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News
- 60 Degrees Pharmaceuticals to Participate in H.C. Wainwright 25th Annual Global Investment ConferenceGlobeNewswire
- 60 Degrees Pharmaceuticals Study Results Published by New Microbes and New Infections Demonstrate Tafenoquine Exhibits Broad Spectrum Antifungal ActivityGlobeNewswire
- 60 Degrees Pharmaceuticals Receives Additional U.S. Patent Covering Tafenoquine for Prevention of Plasmodium Falciparum MalariaGlobeNewswire
- 60 Degrees Pharmaceuticals Registers ACLR8-LR, a Phase IIB Study of Tafenoquine for Treatment of COVID-19, on ClinicalTrials.govGlobeNewswire
- 60 Degrees Pharmaceuticals Awarded Canadian Patent Covering Tafenoquine for Prevention of Malaria in Malaria-Naive SubjectsGlobeNewswire
SXTP
Sec Filings
- 7/12/23 - Form 4
- 7/12/23 - Form 4
- 7/11/23 - Form 3
- SXTP's page on the SEC website