60 Degrees Pharmaceuticals Files New Dietary Ingredient Notification (NDIN) with FDA for Australian Chestnut Extract
Rhea-AI Summary
60 Degrees Pharmaceuticals (NASDAQ: SXTP) submitted a New Dietary Ingredient Notification (NDIN) to the FDA on March 11, 2026, for an Australian Chestnut Extract product; FDA review runs through May 25, 2026.
The company also signed an option to license Florida State University capsule formulation methods and previously exercised a January 2026 license option for large-scale purification rights for castanospermine.
Positive
- NDIN submitted to FDA on March 11, 2026, with May 25 review deadline
- Option agreement signed to license FSU capsule formulation methods
- License exercised in January 2026 for large-scale castanospermine purification
Negative
- FDA may object by May 25, 2026, which could block marketing of the supplement
- Safety claims rely on published literature and past clinical experience, not new human trials
News Market Reaction – SXTPW
On the day this news was published, SXTPW declined 5.20%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
No peer stocks in the listed sector appeared in the momentum scanner, and no same-day peer headlines were recorded, suggesting the move in SXTPW is stock-specific rather than part of a sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 11 | Clinical trial update | Positive | +84.2% | All three patients in expanded-use tafenoquine babesiosis trial achieved cure. |
| Feb 02 | Commercial partnership | Positive | +1.6% | GoodRx collaboration to offer up to 30% savings on ARAKODA at 70,000+ pharmacies. |
| Jan 28 | Licensing and R&D | Positive | -2.9% | Exercised option with FSU for exclusive large-scale castanospermine purification rights. |
| Jan 22 | Access partnership | Positive | +70.6% | Runway Health partnership to provide online consultations and ARAKODA delivery for travelers. |
| Jan 15 | Reverse stock split | Negative | +8.7% | One-for-four reverse split approved to help regain Nasdaq minimum bid compliance. |
Recent positive catalysts (clinical data and partnerships) often coincided with sharp upside moves, though some constructive licensing news drew a negative reaction, indicating inconsistent but sometimes strong sensitivity to news.
Over the past few months, 60 Degrees Pharmaceuticals reported several notable milestones. A January 2026 reverse stock split addressed Nasdaq bid requirements, while partnerships with Runway Health (effective April 2, 2026) and GoodRx sought to expand ARAKODA access. A January license option with Florida State University focused on large-scale castanospermine purification, tying directly to today’s Australian Chestnut Extract NDIN. Most recently, a March 11, 2026 expanded-use babesiosis trial update reported all patients were cured, which coincided with a strong price gain.
Market Pulse Summary
The stock moved -5.2% in the session following this news. A negative reaction despite constructive regulatory progress would fit a pattern where the market sometimes discounted long‑dated or early‑stage initiatives, as seen when prior castanospermine licensing news coincided with a price decline. While the NDIN and FSU capsule formulation option expand the non‑prescription platform, fundamentals still show net revenue of only $257,820 and a six‑month net loss of $3,612,231, so balance sheet and commercialization execution would remain central concerns.
Key Terms
new dietary ingredient notification regulatory
u.s. food and drug administration regulatory
FDA regulatory
immunomodulation medical
clinical trials medical
metabolite medical
pharmacological targets medical
AI-generated analysis. Not financial advice.
- FDA has until May 25, 2026 to object to the notification, after which the Company will be free to market its proposed dietary supplement containing Australian Chestnut Extract
- Company has signed an option agreement with Florida State University (FSU) to license a capsule formulation, expanding on its recent exercise of a license option for large-scale production
WASHINGTON, March 18, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced it submitted a New Dietary Ingredient Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian Chestnut Extract on March 11, 2026. FDA has until May 25, 2026, to object to the notification, after which the Company will be free to market its planned dietary supplement containing Australian Chestnut Extract.
The Company has also signed an option agreement to license Florida State University’s (FSU) ownership rights related to new capsule formulation methods for Australian Chestnut Extract, which FSU jointly owns with the Company. This expands on the Company’s January 2026 exercise of a license option with FSU for exclusive rights to large-scale purification of Castanospermine for non-prescription uses.
Australian Chestnut Extract is derived from the seeds of Castanospermum australe (commonly known as the Australian Chestnut, the Moreton Bay Chestnut, and the Black Bean Tree). The dominant molecular constituent of Australian Chestnut Extract is castanospermine.
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.
Castanospermine is also a metabolite of celgosivir, a product evaluated in clinical trials in more than 500 patients against HIV and Hepatitis C, but which is no longer in commercial development for those indications. That safety record suggests castanospermine is safe at achievable doses in humans and is active against the same pharmacological targets as in animal studies.
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) 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.
Cautionary Note Regarding Forward-Looking Statements
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 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 March 27, 2025 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
