60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP) announced that all three patients enrolled in its expanded access study for relapsing babesiosis were successfully cured after completing a treatment regimen based on tafenoquine, according to a company press release.
Despite the positive clinical update, the company’s stock has struggled over the past year. Shares recently traded at about $1.88, representing a decline of roughly 72% over the past 12 months and remaining close to a 52-week low of $1.36. The stock’s beta of 2.71 reflects the elevated volatility typically associated with early-stage biotechnology firms. Analysts currently maintain a strong buy consensus, with price targets ranging from $11.20 to $24, suggesting notable potential upside if the therapy advances through regulatory pathways.
The open-label, multi-center study is evaluating the safety and effectiveness of the ARAKODA-based tafenoquine regimen in combination with atovaquone and other antimalarial or antibiotic therapies. The trial focuses on immunocompromised patients suffering from relapsing babesiosis who previously failed standard treatments. The research is intended to validate findings from a 2024 publication by the Yale School of Public Health in the journal Clinical Infectious Diseases.
Patients in the trial receive tafenoquine for up to one year, continuing treatment until two consecutive negative PCR tests for Babesia parasites are obtained and symptoms resolve. A patient is considered cured if no evidence of infection appears 60 to 90 days after treatment ends, confirmed through an FDA-approved RNA amplification test that is at least 1,000 times more sensitive than standard commercial RT-PCR diagnostics.
The first two patients achieved cures using a triple combination of tafenoquine, atovaquone and an antibiotic. The third patient was treated successfully with a four-drug regimen consisting of atovaquone, azithromycin, proguanil and weekly tafenoquine.
Including previously published Yale data, a total of seven patients have now been evaluated. According to the company, the combined evidence indicates that the cure rate for relapsing babesiosis in immunocompromised individuals may approach 100% when weekly tafenoquine is added to an atovaquone-based treatment and continued until two negative PCR tests are recorded.
Despite the encouraging clinical findings, the company’s financial performance remains modest. Revenue over the twelve months through the second quarter of 2025 totaled approximately $980,000, although revenue growth accelerated by 129%. The company remains unprofitable, reporting negative EBITDA of $7.63 million.
Babesiosis is a tick-borne infection frequently seen as a co-infection in patients with Lyme disease. Symptoms can include fever, chills, sweating and fatigue, and the illness can become life-threatening in elderly or immunocompromised individuals. Currently, there are no FDA-approved treatments or vaccines specifically for babesiosis.
Tafenoquine itself is not approved by the U.S. Food and Drug Administration for the treatment of babesiosis. However, the drug is approved in the United States as a malaria prevention therapy under the brand name ARAKODA.
Separately, 60 Degrees Pharmaceuticals has recently faced several corporate developments. The company received a delisting notice from Nasdaq after failing to meet the minimum bid price requirement of $1.00 per share for 30 consecutive business days, prompting exchange staff to determine that its common shares and warrants should be removed from the Nasdaq Capital Market.
In another update, the company announced a partnership with GoodRx aimed at offering discounts on prescriptions for ARAKODA, potentially providing eligible consumers with savings of up to 30%.
The company has also exercised an option to negotiate an exclusive licensing agreement with Florida State University related to large-scale purification techniques for castanospermine. The compound, derived from seeds of the Australian chestnut tree, has demonstrated potential in animal studies for influencing carbohydrate metabolism and modifying disease outcomes.