Key Takeaways:
- Firefly Neuroscience and Next Health launched a precision cognitive health platform
- FDA advisory panel recommended easing compounding restrictions on six peptides
- Imports of peptide compounds from China doubled to $328 million in 2025
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Firefly and Next Health launch cognitive initiative after FDA backs 6 peptides
Firefly Neuroscience is partnering with Next Health to combine AI-powered brain biomarkers with peptide therapies, capitalizing on an FDA advisory panel's recommendation to ease compounding restrictions on six neuroprotective peptides.
Firefly Neuroscience partnered with Next Health to launch a precision cognitive health platform, capitalizing on an FDA advisory panel's recommendation to ease compounding restrictions on six peptides including Epitalon and Semax.
"Combining Firefly's quantitative brain biomarkers with Next Health's clinical expertise has the potential to redefine how cognitive health is measured, personalized, and monitored," Greg Lipschitz, Firefly's chief executive officer, said.
Firefly's FDA 510(k)-cleared Evoke System uses AI to analyze EEG/ERP brain scans from a proprietary database of more than 200,000 records — the world's largest known standardized repository. Next Health, founded more than a decade ago, operates a network of longevity clinics offering biomarker-driven health optimization and therapies including NAD+ infusion and glutathione.
The partnership comes as the gray market for unapproved peptides has surged. Imports of hormone and peptide compounds from China roughly doubled to $328 million in the first three quarters of 2025 from $164 million in the same period of 2024, according to U.S. customs data. Firefly, which trades on the Nasdaq under the ticker AIFF, is positioning its diagnostic platform to become the measurement standard as regulatory barriers fall.
FDA Panel Backs Six Peptides, Rejects One
The Pharmacy Compounding Advisory Committee voted last week to recommend adding Epitalon, Semax, BPC-157, KPV, TB-500, and MOTs-C to the list of bulk drug substances eligible for pharmacy compounding. Only one peptide, emideltide, was rejected. The recommendation, while not binding, marks a regulatory milestone that could broaden physician access to therapies that have attracted growing scientific interest for their potential neuroprotective and cognitive-supportive properties.
Epitalon, a synthetic peptide derived from the pineal gland, has been studied for its potential to increase melatonin production and lengthen telomeres, though no human trials have tested it for sleep outcomes specifically. Semax, a synthetic fragment of adrenocorticotropic hormone, has shown promise in human studies for treating ischemic stroke, primarily in Eastern European trials, but larger high-quality studies remain lacking.
The FDA had recommended against reclassifying any of the peptides, citing insufficient evidence on safety and efficacy. Several panel members disclosed financial ties to peptide-related businesses, according to the Associated Press.
What the Regulatory Shift Means for Investors
The advisory committee's vote follows a broader policy shift under the Trump administration. In February, Health and Human Services Secretary Robert F. Kennedy Jr. told Joe Rogan he was a "big fan of peptides" and wanted to make several legally accessible. In April, 12 peptides were removed from the FDA's Category 2 list — substances deemed to present significant safety risks — and referred for re-evaluation.
For Firefly, the timing aligns with its push to establish objective brain measurement as a standard component of longevity medicine. The company's EEG-based platform provides quantitative biomarkers that can track cognitive function before, during, and after treatment — replacing subjective assessments with data-driven clinical decision-making.
Dr. Darshan Shah, founder and chief executive officer of Next Health, said the partnership enables clinicians to "objectively measure brain function before, during and after treatment," adding that brain mapping could become "an important component of personalized cognitive medicine."
The companies plan to develop standardized clinical protocols integrating Firefly's platform with provider-guided peptide therapies and expect to provide updates as key milestones are achieved. Firefly's cash position and cash runway were not disclosed in the announcement.
This article is for informational purposes only and does not constitute investment advice.
[1] Firefly Neuroscience (NASDAQ: AIFF) and Next Health Launch Precision Cognitive Health Initiative as FDA Advisory Committee's Recommendation Backs Broader Access to Key Neuroprotective Peptides[2] Firefly Neuroscience (NASDAQ: AIFF) and Next Health Launch Precision Cognitive Health Initiative as FDA Advisory Committee’s Recommendation Backs Broader Access to Key ...[3] FDA Panel Votes To Ease Restrictions on 6 Peptides—But Experts Still Have Major Concerns[4] FDA panel backs two peptides for compounding, rejects one[5] The Peptide Gray Market Is Already Here. The FDA Is Just Catching Up.
