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

Rhea-AI Summary

60 Degrees Pharmaceuticals (NASDAQ: SXTP) has announced the potential market size for ARAKODA® (tafenoquine) in treating human babesiosis, projecting maximum annual sales of $245 million and a cumulative market value of $1.1 billion through patent expiration in 2035.

The market assessment is based on comprehensive research including a 6,000-patient nationwide survey and feedback from 300 healthcare professionals. The company estimates a total addressable market of 380,000 patients annually.

Currently, three clinical trials are underway or planned to evaluate tafenoquine's safety and efficacy. The company expects to submit a New Drug Application (NDA) to the FDA in 2026, pending positive trial results.

Positive

• Potential annual market of $245 million and cumulative market of $1.1 billion through 2035
• Large addressable market of 380,000 patients annually
• Patent protection extends through 2035
• Three clinical trials in progress to support FDA approval
• No FDA-approved treatments exist, positioning ARAKODA as a potential first-in-class therapy

Negative

• NDA submission not planned until 2026
• Clinical trial results still pending and required for approval
• Market projections dependent on successful trial outcomes and FDA approval

Insights

Pharmaceutical Investment Analyst

60P identifies $245M annual market for ARAKODA in babesiosis; promising opportunity if clinical trials succeed, but significant execution risks remain.

60 Degrees Pharmaceuticals has quantified a substantial commercial opportunity for ARAKODA (tafenoquine) in human babesiosis, projecting an annual total addressable market (TAM) of $245 million with 380,000 potential patients. The cumulative opportunity through patent expiration in 2035 is estimated at $1.1 billion. These figures derive credibility from market research involving 6,000 patients and 300 healthcare professionals.

The commercial thesis is compelling: babesiosis represents an underserved market with no FDA-approved treatments, frequent resistance issues with current generic options, and a connection to the more widely recognized Lyme disease. This creates an attractive opportunity for a pharmaceutical company with a modest market cap like 60P.

However, investors should note several key uncertainties: the company still needs to generate positive data from three clinical trials before submitting an NDA in 2026. The press release provides no insight into trial design, endpoints, or preliminary efficacy signals. The projected timeline suggests data availability in H1 2026 with submission later that year—an ambitious schedule that leaves little room for setbacks.

The addressable market calculation appears thorough but represents a theoretical maximum rather than a likely penetration rate. Real-world factors including insurance coverage, physician adoption patterns, and competitive dynamics will determine actual market share. The timing of potential revenue generation—likely 2027 at earliest assuming approval—means this opportunity represents a medium-term value driver rather than an immediate catalyst.

• New Drug Application intended for 2026, subject to generation of positive data from three U.S. clinical trials planned or in progress
  
  
• Total addressable market (TAM) for ARAKODA for Human Babesiosis is informed by results of a 6,000 nationwide patient survey and a quantitative research study involving 300 healthcare professionals
  

WASHINGTON, July 15, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced it has determined the maximum size of the commercial market for ARAKODA^® (tafenoquine) for treatment of human babesiosis to be 380,000 patients/$245,000,000 in sales annually, with a cumulative TAM of 1.17 million patients/$1.1 billion through patent expiration in 2035. Human babesiosis is a serious and debilitating emerging tick-borne illness often found as a co-infection in patients with Lyme Disease. There is a substantial unmet medical need due to the lack of FDA-approved treatments and the frequent generation of resistance associated with repeated use of generic drugs to manage persistent disease.

TAM calculations were based on a nation-wide 6,000 patient survey and a quantitative research survey of 300 healthcare professionals conducted by Format Analytics, an independent market research firm.

“The full extent to which 60 Degrees Pharmaceuticals may be in a position to improve the lives of large numbers of people who suffer with babesiosis is now coming into view,” said Chief Executive Office of 60 Degrees Pharmaceuticals, Geoff Dow, PhD. “Yet, no approved treatment exists for this disabling and sometimes deadly disease. As the leader in this space, our goal is to continue advancing our robust clinical research program evaluating tafenoquine for babesiosis, and to secure approval of a supplemental indication for ARAKODA as expeditiously as possible.”

Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals
Three 60 Degrees Pharmaceuticals-sponsored clinical trials (NCT06478641, NCT06207370, NCT06656351) are underway or planned to evaluate tafenoquine’s safety and efficacy in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies in the first half of 2026 and will be used as part of a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration for babesiosis, anticipated in 2026.

About ARAKODA^® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.

ARAKODA^® (tafenoquine) Important Safety Information

ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.

Contraindications

ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA^®.
  

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®.

To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based Pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com. The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safeharbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contacts:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com

FAQ

What is the projected market size for SXTP's ARAKODA in treating babesiosis?

60 Degrees Pharmaceuticals projects maximum annual sales of $245 million and a cumulative market value of $1.1 billion through patent expiration in 2035, based on an estimated 380,000 patients annually.

When does 60 Degrees Pharmaceuticals plan to submit the NDA for ARAKODA's babesiosis indication?

The company plans to submit the New Drug Application (NDA) to the FDA in 2026, following the completion of ongoing clinical trials.

How many clinical trials is SXTP conducting for ARAKODA in babesiosis?

60 Degrees Pharmaceuticals is conducting three clinical trials (NCT06478641, NCT06207370, NCT06656351) to evaluate tafenoquine's safety and efficacy in treating babesiosis.

What research supports SXTP's market size projections for ARAKODA?

The market projections are based on a nationwide survey of 6,000 patients and a quantitative research study involving 300 healthcare professionals, conducted by Format Analytics.

When does SXTP's patent protection for ARAKODA expire?

The patent protection for ARAKODA extends through 2035.