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from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of 60 Degrees Pharmaceuticals, has withdrawn its IND for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19; Company plans to resubmit a revised IND later in 2023, pending a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medicines for infectious diseases, today announced that 60P Australia Pty Ltd, a majority-owned subsidiary of 60P, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase IIB study of the use of tafenoquine in treating COVID-19, and intends to sub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 Awarded Contract with U.S. Army for ARAKODA® Supply Chain Upgrade SupportGlobeNewswire
- 60 Degrees Pharmaceuticals Signs Clinical Trial Agreements With All Planned Trial Sites for Tafenoquine Babesiosis StudyGlobeNewswire
- 60 Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior Treatment [Yahoo! Finance]Yahoo! Finance
- 60 Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior TreatmentGlobeNewswire
- First Patient Enrolled in 60 Degrees Pharmaceuticals Clinical Trial of Tafenoquine for Babesiosis at Tufts Medical Center; First and Only Study of Its KindGlobeNewswire
SXTP
Analyst Actions
- 6/6/24 - HC Wainwright
SXTP
Sec Filings
- 7/26/24 - Form 8-K
- 7/26/24 - Form 424B5
- 7/24/24 - Form 424B5
- SXTP's page on the SEC website