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

Key Figures

FDA objection deadline: May 25, 2026 NDIN submission date: March 11, 2026 Patients in prior trials: more than 500 patients

3 metrics

FDA objection deadline May 25, 2026 Last day for FDA to object to NDIN for Australian Chestnut Extract

NDIN submission date March 11, 2026 Date NDIN for Australian Chestnut Extract was submitted to FDA

Patients in prior trials more than 500 patients Clinical trials of celgosivir in HIV and Hepatitis C

Market Reality Check

Price: $2.25 Vol: Volume 297,930 is 0.09x t...

low vol

$2.25 Last Close

Volume Volume 297,930 is 0.09x the 20-day average of 3,239,195, indicating light trading ahead of this news. low

Technical Shares at $2.25 are trading below the 200-day MA of $5.26 and 87.27% below the 52-week high of $17.68.

Peers on Argus

Peer action is mixed: ARTL up 10.73%, KTTA up 1.81%, while TTNP, PLRZ, and SILO ...

3 Up

Peer action is mixed: ARTL up 10.73%, KTTA up 1.81%, while TTNP, PLRZ, and SILO are down. Momentum scanner shows three biotech peers (ARTL, ADTX, PLRZ) to the upside, but SXTP’s own direction was not captured, so the move appears stock-specific rather than a clear sector rotation.

Historical Context

5 past events · Latest: 2026-03-11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2026-03-11	Clinical trial update	Positive	+71.3%	Expanded-use tafenoquine trial reported all three relapsing babesiosis patients achieved cure.
2026-02-02	Commercial partnership	Positive	-12.3%	GoodRx partnership to offer up to 30% savings on ARAKODA at 70,000+ pharmacies.
2026-01-28	Licensing agreement	Positive	+7.9%	Exercised FSU option for exclusive large-scale castanospermine purification for non-Rx use.
2026-01-22	Distribution partnership	Positive	+152.0%	Runway Health partnership to provide online consults and delivery of ARAKODA from Apr 2, 2026.
2026-01-15	Reverse stock split	Neutral	-2.4%	Approved one-for-four reverse split to help maintain Nasdaq bid price compliance.

Pattern Detected

Recent SXTP news often triggered sharp upside moves on positive catalysts, though one commercial partnership saw a negative reaction.

Recent Company History

Over the past months, SXTP has combined clinical progress, commercial partnerships, and capital structure changes. On Jan 15, 2026, it approved a 1:4 reverse split. Partnerships with Runway Health (Apr 2, 2026 start) and GoodRx aimed to expand ARAKODA® access, with price moves of 152% and -12.29% respectively. Clinical updates, including a babesiosis trial with a 71.28% move and earlier castanospermine licensing, show strong market sensitivity to development milestones, into which today’s NDIN filing for Australian Chestnut Extract fits strategically.

Market Pulse Summary

This announcement highlights SXTP’s push into non-prescription, botanical products via an NDIN for A...

Analysis

This announcement highlights SXTP’s push into non-prescription, botanical products via an NDIN for Australian Chestnut Extract, backed by prior celgosivir experience in over 500 patients. It follows earlier steps with Florida State University on castanospermine production, suggesting a coherent strategy around this molecule. Investors may watch for FDA feedback by May 25, 2026, subsequent commercialization plans, and how this effort complements the company’s vector-borne disease portfolio and recent clinical milestones.

Key Terms

u.s. food and drug administration, fda, immunomodulation, pharmacological targets

4 terms

u.s. food and drug administration regulatory

"Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

immunomodulation medical

"In animal models, high doses have been shown to impact disease outcomes ... through immunomodulation."

Immunomodulation is the intentional changing of the immune system’s activity—either ramping it up, calming it down, or redirecting it—to treat disease or prevent harmful reactions. Think of it like adjusting a thermostat for the body’s defenses: the goal is to achieve the right balance so patients heal without excessive inflammation or infection risk. For investors, immunomodulation matters because therapies in this area can address many diseases, carry regulatory and safety considerations, and often determine commercial potential and clinical risk.

pharmacological targets medical

"safe at achievable doses in humans and is active against the same pharmacological targets"

Pharmacological targets are specific molecules in the body—often proteins such as receptors or enzymes—that a drug is designed to bind or modify to change a biological process. For investors, the target is like the lock a drug’s key is made for: it helps indicate how likely the medicine is to work, how selective it may be (impacting side effects), and how challenging the development and approval path — all key drivers of potential commercial value.

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

FAQ

What did 60 Degrees Pharmaceuticals (SXTP) file with the FDA on March 11, 2026?

They filed a New Dietary Ingredient Notification (NDIN) for Australian Chestnut Extract on March 11, 2026. According to 60 Degrees Pharmaceuticals, FDA has until May 25, 2026, to object before marketing may proceed.

When will FDA complete its review of SXTP's Australian Chestnut Extract NDIN?

FDA's review period runs through May 25, 2026, after which no objection clears the way to market. According to 60 Degrees Pharmaceuticals, that date is the agency's objection deadline.

What intellectual property steps did SXTP take related to the chestnut supplement?

60 Degrees signed an option to license FSU capsule formulation methods and earlier exercised a January 2026 license option. According to 60 Degrees Pharmaceuticals, both actions expand manufacturing and formulation rights.

What is the active constituent in the Australian Chestnut Extract SXTP plans to market?

The dominant constituent is castanospermine, noted for metabolic and immunomodulatory effects in literature. According to 60 Degrees Pharmaceuticals, historical clinical data on related molecules suggest tolerability at achievable doses.

If FDA objects to the NDIN, what happens to SXTP's marketing plans?

An FDA objection would prevent marketing the planned dietary supplement until issues are resolved. According to 60 Degrees Pharmaceuticals, the May 25, 2026 deadline is pivotal for moving forward with commercialization.