60 Degrees Pharmaceuticals Signs Exclusive Patent License Agreement with Florida State University for Non-Prescription Use of Australian Chestnut Extract as a Botanical Supplement
Rhea-AI Summary
60 Degrees Pharmaceuticals (NASDAQ:SXTP) signed an exclusive patent license with Florida State University to enable large-scale extraction and purification of castanospermine from Castanospermum australe seeds for non-prescription uses.
The FDA issued a Non-Notification Letter on the company’s New Dietary Ingredient Notification for Australian Chestnut Extract; a meeting is set for July 1, 2026, to clarify required safety information before a revised filing.
Positive
- Exclusive patent license enables large-scale extraction and purification of castanospermine
- Agreement supports non-prescription development of Australian Chestnut Extract as a botanical supplement
- Planned revised NDIN after FDA feedback may improve regulatory clarity for the product
Negative
- FDA Non-Notification Letter indicates current NDIN does not yet meet regulatory requirements
- Additional “other safety information” is required before FDA will accept the proposed supplement use
- Regulatory timing for U.S. marketing of Australian Chestnut Extract remains uncertain
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 26 | Clinical trial update | Positive | +1.4% | Early seasonal enrollment in tafenoquine babesiosis trial ahead of schedule. |
| May 15 | Quarterly earnings | Negative | -4.8% | Low net product revenue with higher operating expenses and net loss. |
| Apr 15 | Commercial access news | Positive | -11.7% | ARAKODA malaria prevention made available via Runway Health telehealth. |
| Mar 31 | Annual results | Positive | +15.9% | FY2025 revenue growth, lower operating expenses, and improved net loss. |
| Mar 18 | Regulatory filing | Positive | -5.8% | NDIN submission to FDA for Australian Chestnut Extract dietary product. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Mixed reactions: positive operational updates have sometimes sold off, while larger strategic/financial updates have drawn stronger upside moves.
Over recent months, 60 Degrees Pharmaceuticals reported several catalysts. A March 11, 2026 NDIN filing for Australian Chestnut Extract preceded today’s licensing and FDA feedback update, indicating continued pursuit of a botanical supplement path. Financially, FY2025 results on March 31, 2026 showed net product revenues of $1.005M with improved net loss, and Q1 2026 results on May 15, 2026 highlighted modest revenues and ongoing losses. Clinically, the tafenoquine babesiosis trial began seasonal enrollment ahead of schedule, while ARAKODA access expanded via telehealth partnerships.
Key Terms
new dietary ingredient notification regulatory
dietary supplement regulatory
immunomodulation medical
carbohydrate metabolism medical
clinical markers medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- License allows the Company to commence large-scale extraction of castanospermine from the seeds of Castanospermum australe
- Company will meet with FDA on July 1, 2026, to discuss Non-Notified Letter issued by the Agency in response to the Company’s recent New Dietary Ingredient Notification (NDIN) to market Australian Chestnut Extract in the U.S.
WASHINGTON, June 11, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or “60 Degrees Pharma”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced that the Company has executed a patent licensing agreement with Florida State University to commence large-scale production techniques to extract and purify castanospermine from the seeds of Castanospermum australe (commonly known as the Australian Chestnut, the Moreton Bay Chestnut, and the Black Bean Tree) for non-prescription uses. Castanospermine is the principal component of Australian Chestnut Extract.
According to recent scientific literature, at low doses, castanospermine modulates carbohydrate metabolism, altering glycogen, glucose levels and other clinical markers. In animal models, high doses have been shown to impact disease outcomes in several therapeutic areas through immunomodulation.
The U.S. Food and Drug Administration (FDA or “the Agency”) has issued a Non-Notification Letter to 60 Degrees Pharma providing feedback on the Company’s recent filing of a New Dietary Ingredient Notification (NDIN) for Australian Chestnut Extract. 60 Degrees Pharma and the Agency will meet on July 1, 2026, to discuss the feedback, including clarification regarding the minimum required “other safety information” to establish the safety of the proposed use of Australian Chestnut Extract in a dietary supplement. Subsequently, the Company will submit a revised NDIN.
Castanospermum australe grows primarily in the Australian states of Queensland and New South Wales, and in Florida, Hawaii, and California. The processed seeds of Castanospermum australe have been a traditional food source in Australia for thousands of years.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a 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.
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This press release may contain “forward-looking statements” within the meaning of the safe harbor 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 Australian Chestnut Extract 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 March 30, 2026, 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 Contact
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact
Patrick Gaynes
patrickgaynes@60degreespharma.com
