SXTP (60 Degrees Pharmaceuticals, Inc.) PDUFA Date

Jul 8, 2026

60 Degrees Pharmaceuticals Announces Exclusive Option Agreement with Florida State University to Advance Castanospermine for Tick-Borne Diseases

60 Degrees Pharmaceuticals has signed an exclusive option agreement with Florida State University to develop castanospermine for various tick-borne diseases, including Powassan virus disease and Lyme disease. This agreement allows the company to negotiate a U.S. license for the patented technology and develop a commercialization strategy. The compound has shown broad antiviral activity in preclinical studies.

Jul 1, 2026

60 Degrees Pharmaceuticals Announces Positive Recommendation from Data Safety Monitoring Board for B-FREE Phase 2 Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue

60 Degrees Pharmaceuticals announced a positive recommendation from the Data Safety Monitoring Board to continue the B-FREE Phase 2 study of tafenoquine for treating chronic babesiosis patients suffering from severe fatigue. The study aims to assess the efficacy of tafenoquine in alleviating fatigue over a 90-day treatment period. Currently, there are no FDA-approved treatments for babesiosis, highlighting the significance of this research.

Jun 11, 2026

60 Degrees Pharmaceuticals Signs Exclusive Patent License Agreement with Florida State University for Non-Prescription Use of Australian Chestnut Extract as a Botanical Supplement

60 Degrees Pharmaceuticals has signed an exclusive patent license with Florida State University to extract castanospermine from Australian Chestnut seeds for non-prescription use. The company plans to meet with the FDA on July 1, 2026, to discuss feedback on their New Dietary Ingredient Notification for the extract. The FDA's Non-Notification Letter raises questions about safety information required for market approval.

60 Degrees Pharmaceuticals Announces 2025 Annual Results

60 Degrees Pharmaceuticals reported a 65% increase in net product revenues for FY 2025, reaching $1,005,000. The company also noted a reduction in operating expenses and an improvement in net loss compared to the previous year. Recent business highlights include successful treatment outcomes in an expanded access study and partnerships to enhance sales of its product ARAKODA. However, the company faces challenges such as high operating costs and inventory write-offs.

60 Degrees Pharmaceuticals Expands Access to ARAKODA® with GoodRx Partnership

60 Degrees Pharmaceuticals has partnered with GoodRx to provide savings on ARAKODA, a malaria prevention medication. Starting February 2, 2026, eligible patients can access discounts of up to 30% at over 70,000 pharmacies nationwide. ARAKODA is the only FDA-approved, once-weekly prescription for malaria prophylaxis in the U.S.

Jan 29, 2026

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60 Degrees Pharmaceuticals Exercises License Option with Florida State University for Large-Scale Purification of Castanospermine for Non-Rx Use

60 Degrees Pharmaceuticals has exercised its option to negotiate an exclusive license with Florida State University for large-scale purification of castanospermine from Australian Chestnut seeds. The company is preparing to enter the U.S. market with this botanical product for non-prescription use, following successful safety testing and development of oral formulations. Castanospermine has shown potential benefits in modulating carbohydrate metabolism and impacting disease outcomes in animal studies.

Jan 23, 2026

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60 Degrees Pharmaceuticals Announces Partnership with Runway Health to Provide International Travelers Direct Access to ARAKODA® for Malaria Prevention

60 Degrees Pharmaceuticals has partnered with Runway Health to enhance access to ARAKODA, a malaria prevention medication, for international travelers. This collaboration will allow travelers to receive personalized medical treatment plans and home delivery of the medication before their trips. ARAKODA is notable for being the only once-weekly malaria prophylaxis available in the U.S.

Jan 16, 2026

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60 Degrees Pharmaceuticals, Inc. Announces Approval of Reverse Stock Split Ratio

60 Degrees Pharmaceuticals, Inc. has announced a one-for-four reverse stock split effective January 20, 2026. This decision follows stockholder approval and aims to ensure compliance with Nasdaq's minimum bid price requirements. The split will reduce the number of outstanding shares significantly, while maintaining the par value and not altering stockholders' percentage interests.

Jan 15, 2026

Degrees Pharmaceuticals, Inc. Announces Approval of Reverse Stock Split Ratio

60 Degrees Pharmaceuticals, Inc. has announced an upcoming one-for-four reverse stock split effective January 20, 2026, to comply with Nasdaq's listing requirements. This decision was approved by stockholders at a special meeting in October 2025 and aims to improve the stock price perception for potential investors. Post-split, the company will have approximately 1,287,192 shares outstanding, while the par value will remain unchanged. The reverse split will adjust all outstanding options and related securities accordingly, while not altering stockholders' percentage interests significantly.

Jan 8, 2026

SXTPConferences/Events

Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserved. October 2025 1 - 8 - 26 Webinar Disclaimer and Forward - looking Statements 2024 60 Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserved. DISCLAIM

Degrees Pharmaceuticals, Inc. has outlined a commercial strategy for its malaria treatment, ARAKODA. The plan includes increasing awareness and differentiating ARAKODA from generic alternatives through targeted marketing efforts. Additionally, the company aims to boost trial usage by engaging more inside sales representatives to prompt healthcare providers to prescribe the medication based on its unique attributes. They are also addressing affordability issues to manage the high out-of-pocket costs for patients, using tools like GoodRx discounts.

60 Degrees Pharmaceuticals Announces Detection of Babesia Infection in 24 Percent of Patients Presenting with Chronic Fatigue in Peer-Reviewed, Sponsored Study at NC State

60 Degrees Pharmaceuticals announced that a study found Babesia infection in 24% of patients with chronic fatigue. This research, conducted at North Carolina State University, supports the theory that Babesia may prolong recovery from chronic fatigue. The company is currently enrolling participants in the B-Free Study to evaluate the efficacy of tafenoquine for treating chronic babesiosis.

60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026

60 Degrees Pharmaceuticals announced plans to expand sales and marketing for ARAKODA after a successful commercial pilot indicated increased demand. The company will enhance its digital marketing efforts and add clinical sites for babesiosis studies following FDA feedback. This expansion reflects the company's commitment to improving access to malaria prevention.

Nov 21, 2025

60 Degrees Pharmaceuticals Announces Clinical Site Now Open for Patient Enrollment for the B-FREE Chronic Babesiosis Study at Mount Sinai Icahn School of Medicine

60 Degrees Pharmaceuticals has announced the opening of the Cohen Center for Recovery from Complex Chronic Diseases at Mount Sinai Icahn School of Medicine for patient enrollment in the B-FREE Chronic Babesiosis Study. This Phase 2 study will evaluate the efficacy and safety of tafenoquine over 90 days for patients suffering from chronic babesiosis. The study aims to clarify the prevalence of the disease and the potential of tafenoquine to alleviate severe fatigue associated with it.

Nov 13, 2025

60 Degrees Pharmaceuticals Announces Third Quarter 2025 Results

60 Degrees Pharmaceuticals, Inc. announced its financial results for the third quarter of 2025, highlighting its focus on vector-borne diseases. The company achieved FDA approval for its lead product, ARAKODA® (tafenoquine), in 2018. However, it faces significant challenges, including doubts about its ongoing viability and the need for successful clinical trials for future products.

60 Degrees Pharmaceuticals Announces No Detection of Babesia Infection in First Patient Following Treatment with Tafenoquine in Relapsing Babesiosis Study

60 Degrees Pharmaceuticals announced that the first patient in their expanded access study for relapsing babesiosis tested negative for the infection after treatment with tafenoquine. This study aims to evaluate the safety and efficacy of tafenoquine combined with standard care in immunosuppressed patients. The company has submitted a Breakthrough Therapy Application to the FDA for tafenoquine's use in treating babesiosis.

Oct 9, 2025

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60 Degrees Pharmaceuticals Unveils Name of Chronic Babesiosis Clinical Trial: B-FREE Chronic Babesiosis Study

60 Degrees Pharmaceuticals has announced the B-FREE Chronic Babesiosis Study, the first clinical trial aimed at evaluating a new treatment for chronic babesiosis. This Phase 2 open-label study will assess the efficacy and safety of the ARAKODA regimen over 90 days. The trial is significant as there are currently no FDA-approved treatments for this condition, which poses a growing public health threat.

Sep 9, 2025

SXTPConferences/Events

Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserved. September 2025 H.C. Wainwright Presentation Disclaimer and Forward - looking Statements 2024 60 Degrees Pharmaceuticals, Inc. CONFIDENTIAL All rights reserv

Degrees Pharmaceuticals is actively working to enhance the use of ARAKODA for malaria, focusing on increasing awareness and differentiating the product from generics. The company aims to encourage healthcare providers to prescribe ARAKODA based on its attributes while managing affordability through co-pay assistance programs. These efforts address potential financial barriers to patient access.

Sep 3, 2025

SXTPConferences/Events

60 Degrees Pharmaceuticals Live Webcast Link and New Date for Presentation at H.C. Wainwright 27th Annual Global Investment Conference

60 Degrees Pharmaceuticals has announced a new date and webcast link for its presentation at the H.C. Wainwright 27th Annual Global Investment Conference. The event is scheduled for September 9, 2025, at 3:30 PM ET, where CEO Dr. Geoff Dow will present and conduct one-on-one meetings. The company focuses on developing medicines for vector-borne diseases and has an FDA-approved product, ARAKODA, for malaria prevention.

Aug 19, 2025

60 Degrees Pharmaceuticals Selects Icahn School of Medicine at Mount Sinai as Central Clinical Trial Site for Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis

60 Degrees Pharmaceuticals has selected the Icahn School of Medicine at Mount Sinai as the central site for a Phase II clinical trial evaluating tafenoquine for chronic babesiosis. The study will assess the efficacy and safety of tafenoquine over 90 days, targeting patients with disabling fatigue and confirmed babesiosis. Results from this trial could support a future New Drug Application to the FDA for babesiosis treatment.

Aug 13, 2025

60 Degrees Pharmaceuticals Announces Second Quarter 2025 Results

60 Degrees Pharmaceuticals reported its Q2 2025 financial results, highlighting a decline in net product revenues due to a resolved supply chain disruption. However, the company achieved increased profitability, driven by cash-pay patients using KODATEF®. The firm anticipates conducting an interim analysis of its hospitalized babesiosis study before the end of the 2025 tick season, contingent on enrollment.

Jul 17, 2025

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60 Degrees Pharmaceuticals and Tulane University Sign Research Agreement to Study Tafenoquine Against Lyme and Bartonella Bacteria

60 Degrees Pharmaceuticals has signed a research agreement with Tulane University to study tafenoquine's effectiveness against Lyme disease and Bartonella bacteria. This initiative aims to address the growing need for effective treatments for these tick-borne diseases. Although tafenoquine is approved for malaria prophylaxis, it has not yet been proven effective for these new indications.

Jul 16, 2025

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60 Degrees Pharmaceuticals Announces Closing of up to $10 Million Public Offering

60 Degrees Pharmaceuticals has successfully closed a public offering, raising $5 million through the sale of shares and warrants. The offering includes Series A-1 and Series A-2 warrants, with potential additional proceeds of $5 million if the latter are exercised. The funds will be used for working capital and corporate purposes, although there are uncertainties regarding the exercise of the warrants and the company's ongoing viability.

Jul 15, 2025

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60 Degrees Pharmaceuticals Announces Pricing of Up to $10 Million Public Offering

60 Degrees Pharmaceuticals has announced the pricing of a public offering aimed at raising up to $10 million through the sale of common stock and warrants. The offering is expected to close on July 16, 2025, subject to customary conditions. The company plans to use the proceeds for working capital and general corporate purposes.

Jul 15, 2025

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60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion

60 Degrees Pharmaceuticals has identified a substantial market for ARAKODA (tafenoquine) in treating human babesiosis, estimating an annual sales potential of $245 million. The cumulative total addressable market could reach $1.1 billion by 2035. The company is conducting clinical trials to evaluate tafenoquine's efficacy for this condition, with data expected in 2026.

Jul 15, 2025

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Degrees Pharmaceuticals Announces Pricing of Up to $10 Million Public Offering $5 million upfront with up to an additional $5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants

Degrees Pharmaceuticals has announced a public offering aimed at raising up to $10 million, comprising an upfront amount of $5 million and the potential for an additional $5 million from short-term warrants. The offering price for the common stock and accompanying warrants is set at $1.90 per share. The proceeds from this offering will be utilized for working capital and general corporate purposes. However, the company cautioned that there is no assurance regarding the exercise of the warrants, and outlined certain risks that may affect its future performance.

Degrees Pharma Announces $1.075 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules WASHINGTON

60 Degrees Pharmaceuticals, Inc. has announced a registered direct offering to raise $1.075 million by selling 1,503,500 shares at a price of $0.715 each. Alongside this, the company will issue short-term warrants for the purchase of additional shares. The offering is expected to close around February 6, 2025, and the funds will be directed towards working capital and general corporate purposes. The company highlights potential risks associated with its future operations and the execution of the offering.

Degrees Pharma Announces $1.043 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules WASHINGTON

60 Degrees Pharmaceuticals has announced a registered direct offering of approximately $1.043 million, set to close on January 30, 2025. The offering consists of over 1 million shares at $1.021 each, alongside short-term warrants for additional shares. Proceeds from this offering will be utilized for working capital and general corporate purposes. The company has a notable focus on developing treatments for infectious diseases, but faces potential challenges regarding its operational continuity and product development timelines.

Jan 28, 2025

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Degrees Pharma Announces IRB Approval of Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis Investigational Review Board (IRB) approval has been granted for the open-label study to evaluate tafenoquine for tre

60 Degrees Pharmaceuticals has received IRB approval for a Phase II study to evaluate tafenoquine for treating chronic babesiosis. The study will last 90 days and aims to assess the efficacy and safety of the ARAKODA regimen in patients with significant functional impairment due to the disease. Enrollment is expected to begin in the third quarter of 2025, reflecting a growing need for effective treatments for babesiosis as its incidence rises in the U.S.

Jan 8, 2025

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Degrees Pharmaceuticals Enrolls First Patient in Tafenoquine Expanded Access Clinical Study for Persistent (B. microti) Babesiosis Case reports published in medical literature suggest that tafenoquine combined with stand

60 Degrees Pharmaceuticals has enrolled its first patient in an expanded access clinical study for tafenoquine, aimed at treating persistent babesiosis in patients who have not responded to standard care. The study follows promising results from a clinical case series indicating an 80% cure rate for tafenoquine in similar patients. This development may significantly benefit a patient population with limited treatment options. Tafenoquine, already approved for malaria prophylaxis under the name ARAKODA, continues to be explored for its potential in treating babesiosis.

Degrees Pharmaceuticals Inc. Announces ARAKODA Promotional Pilot in Advance of Expanded U.S. Launch Highlights include increased ARAKODA ( tafenoquine ) brand awareness and utilization through virtual sales outreach usin

60 Degrees Pharmaceuticals has initiated a nine-month promotional pilot aimed at increasing awareness and utilization of ARAKODA (tafenoquine) prior to a planned expanded U.S. launch. This pilot will involve virtual sales outreach to healthcare providers and is designed to collect data on how ARAKODA is viewed and prescribed. The program includes a co-pay assistance initiative for patients traveling to malaria-endemic areas, and ARAKODA is recognized for its unique position as the only FDA-approved option for malaria prophylaxis. The outcomes from the pilot will inform future strategies for the company's marketing and sales efforts in 2025.

Sep 4, 2024

Degrees Pharmaceuticals, Inc. Announces $4 Million Private Placement Priced At-the-Market Under Nasdaq Rules WASHINGTON

60 Degrees Pharmaceuticals, Inc. announced a $4 million private placement of its common stock and warrants under Nasdaq rules. The offering, which includes nearly 2.9 million shares at a price of $1.38 per share, is anticipated to close around September 5, 2024. Proceeds from the placement are intended for working capital, operations, and research related to their product Arakoda. The company will also file a resale registration statement for the securities offered in this private placement.

Degrees Pharmaceuticals, Inc. Regains Compliance with Nasdaq Listing Requirements WASHINGTON

60 Degrees Pharmaceuticals, Inc. has announced that it has regained compliance with Nasdaq listing requirements as of August 26, 2024. The company was previously notified in February 2024 regarding its non-compliance with the minimum bid price requirement. To rectify this, 60 Degrees successfully maintained a stock price above $1.00 for a necessary duration, achieving a closing price of $1.81 on August 23, 2024. This reflects a significant recovery in their market standing.

Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA NDA in Support of SJ733 Phase IIb Study Published

60 Degrees Pharmaceuticals has granted the University of Kentucky the right of reference to its NDA for ARAKODA to support the SJ733 Phase IIb study. This collaboration allows the FDA to review crucial safety and efficacy data as SJ733 is evaluated in combination with ARAKODA for malaria treatment. SJ733, expected to address drug resistance issues, has demonstrated a favorable safety profile in earlier trials. The initiative aims to develop a new treatment regimen for uncomplicated P. vivax malaria, setting the stage for future pivotal studies.

OF 60 DEGREES PHARMACEUTICALS, INC. DATED AS OF AUGUST 6, 2024 E XHIBIT 99.1 60 Degrees Pharmaceuticals, Inc. Announces 1:12 Reverse Stock Split Published

60 Degrees Pharmaceuticals, Inc. announced a 1-for-12 reverse stock split effective August 12, 2024, to meet Nasdaq's $1.00 minimum bid price requirement. The decision follows stockholder approval and aims to maintain the company's listing on the Nasdaq Capital Market. This action will convert every twelve existing shares into one new share, affecting all stockholders uniformly. The company has faced risks and uncertainties regarding its future operations and financial condition, which may impact its stock performance.

Degrees Pharmaceuticals Awarded Contract with U.S. Army for ARAKODA Supply Chain Upgrade Support 60 Degrees Pharmaceuticals has been awarded a contract with the United States Army Medical Materiel Development Activity to

60 Degrees Pharmaceuticals has secured a contract with the U.S. Army Medical Materiel Development Activity to support the commercial validation of packaging for ARAKODA, its malaria prevention product. This contract is crucial for ensuring a sustainable supply chain for the product, especially after recent increases in sales. ARAKODA has shown significant growth, with Q1 2024 revenues rising sharply compared to the same period last year. The company is optimistic about ARAKODA's future role in malaria prevention and its potential use in treating babesiosis.

Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior Treatment WASHINGTON, D.C.

60 Degrees Pharmaceuticals has received Institutional Review Board (IRB) approval for a clinical study exploring tafenoquine as a treatment for babesiosis in immunocompromised patients. The study follows promising results from a previous case series that indicated an 80% cure rate when using tafenoquine in combination with standard care. This trial aims to further validate these findings and expand access to treatment for those suffering from persistent babesiosis, particularly among vulnerable populations. If successful, the company plans to file for FDA approval for this new indication by mid-2026.

Jun 27, 2024

First Patient Enrolled in 60 Degrees Pharmaceuticals Clinical Trial of Tafenoquine for Babesiosis at Tufts Medical Center; First and Only Study of Its Kind The efficacy and safety of tafenoquine in treating human babesio

60 Degrees Pharmaceuticals announced the enrollment of the first patient in a clinical trial assessing tafenoquine's efficacy and safety for treating babesiosis at Tufts Medical Center. This trial is notable as it is the first of its kind globally, targeting human patients diagnosed with the disease. The study aims to enroll between 24 to 33 patients and is designed to provide valuable insights into a serious tick-borne illness's treatment. Tafenoquine has previously been approved for malaria prophylaxis, but its effectiveness for babesiosis remains unproven and not FDA-approved.

Jun 11, 2024

Degrees Pharmaceuticals Receives FDA Orphan Drug Designation for Tafenoquine for Treatment of Patients with Acute Babesiosis With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals n

60 Degrees Pharmaceuticals has received orphan drug designation from the FDA for tafenoquine, aimed at treating acute babesiosis, a disease transmitted by the Babesia parasite. This designation supports ongoing clinical trials, which will begin recruitment on June 13, 2024, at Tufts Medical Center and other hospitals. The company anticipates that tafenoquine could meet the urgent need for effective treatment options for this potentially life-threatening condition as recent animal studies show encouraging results. While the drug is currently approved for malaria prophylaxis, it does not yet have FDA approval for treating babesiosis.

May 2, 2024

Degrees Pharmaceuticals Receives FDA Comments on Tafenoquine-Babesiosis Clinical Trial Protocol; No Material Changes Required Trial planning and execution to proceed as planned WASHINGTON, D.C.

60 Degrees Pharmaceuticals has announced that the FDA provided comments on their clinical trial protocol for tafenoquine in treating babesiosis, with no material changes required. The company continues to prepare for patient enrollment later this year. Tafenoquine, which is approved for malaria prevention, is being explored for its potential effectiveness against babesiosis, a disease affecting many in the U.S. The trial aims to enroll at least 24 patients, with results expected to contribute valuable data on the drug's efficacy in this new indication.

Degrees Pharmaceuticals Announces Communication from the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024 Washington, D.C.

Degrees Pharmaceuticals, Inc. announced that the FDA will provide its comments on the company's babesiosis trial protocol submission in April 2024, instead of the previously anticipated March 2024 timeline. This adjustment does not require a strict response timeline from the FDA. Despite the delay, the company is preparing to begin the trial on June 1, 2024, as planned. Tafenoquine, the active ingredient, was previously approved by the FDA in 2018 for malaria prophylaxis.

Feb 20, 2024

Degrees Pharmaceuticals to Sponsor Pre-Clinical Studies of Tafenoquine Use in Candida spp , Including Candida auris Candida auris (C. auris) is a dangerous drug-resistant fungal pathogen emerging in U.S. hospitals Tafeno

60 Degrees Pharmaceuticals announced plans to sponsor pre-clinical studies investigating the use of tafenoquine against Candida spp, including multidrug-resistant Candida auris. Conducted by Monash University, the studies aim to assess tafenoquine's efficacy as a treatment for infections that can affect hospitalized patients. The urgency of this research is underscored by the increasing prevalence of drug-resistant infections, emphasizing the need for effective therapeutic options.

Degrees Pharmaceuticals Announces Pricing of $2.4 Million Public Offering WASHINGTON

60 Degrees Pharmaceuticals has announced the pricing of its public offering, aiming to raise approximately $2.4 million. The offering includes 5,260,901 units priced at $0.385 each and 999,076 pre-funded units priced at $0.375. The expected gross proceeds will support working capital, general corporate purposes, and the relaunch of its FDA-approved product ARAKODA for malaria prevention. The offering is expected to close on or about January 31, 2024, pending customary closing conditions.

Degrees Pharma Plans Pivotal Babesiosis Study with Tafenoquine Following Jan 17 FDA Meeting

60 Degrees Pharmaceuticals, Inc. announced plans for a pivotal clinical study of tafenoquine for hospitalized babesiosis patients following a recent FDA meeting. The FDA provided feedback indicating the proposed study could support regulatory approval if designed appropriately. The study aims to recruit participants starting summer 2024 and will take place at three hospitals in the northeastern U.S. The company emphasizes the need for new treatment options as babesiosis cases continue to rise in the U.S.

Degrees Pharmaceuticals Suspends Phase IIB Study of Tafenoquine for COVID-19, Pivots to Refocus on Commercialization of Treatments for Malaria and Tick-Borne Diseases FDA advice to the Company suggested execution of ACLR

60 Degrees Pharmaceuticals has announced the suspension of its Phase IIB study of tafenoquine for COVID-19 due to recent FDA advice indicating that the study's continuation is unfeasible. The company will instead pivot towards the commercialization of treatments for malaria and tick-borne diseases. They are planning a Phase IIA study of tafenoquine for babesiosis, an increasing concern in the U.S. Additionally, the company is focusing on expanding its commercialization efforts for ARAKODA, which has seen significant sales growth.

Sep 18, 2023

Degrees Pharma Withdraws COVID Phase IIB IND, Will Resubmit Pending Assessment of Ability to Meet FDA Requirements Prompted by advice from FDA regarding study design, 60P Australia Pty Ltd, a majority-owned subsidiary of

60 Degrees Pharmaceuticals has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase IIB study involving tafenoquine for COVID-19 treatment. This decision follows feedback from the FDA, which the company plans to address before resubmitting a new IND later this year. In the meantime, the trial's start-up activities have been paused to conserve resources. Additionally, 60P is continuing its work on a Phase IIA study of tafenoquine for babesiosis and reaffirming its commitment to its malaria drug, ARAKODA, which has seen significant sales growth.

Jul 12, 2023