2026 predictions: historic FDA shift, plausible mechanisms, bespoke tx, RFK Jr., biotechs, state AGs, peptides, embryos

I do yearly predictions for the stem cell and regenerative medicine field. Today’s post discusses my 2026 predictions. You can also see my 2025 stem cell predictions and their grades. It was one of the most accurate years.

Now, there’s still a lot swirling around in the regenerative medicine field, the FDA, RFK Jr., politics, peptides, wellness and longevity influencers, and more. So you can see it’s not simply “stem cells.” These other elements are likely to be areas of important news in 2026.

I believe this could be one of the most significant years of change at the FDA on biologics, cell and tissue products in decades.

Let’s start with the vision for the FDA in 2026.

FDA approvals and policies

• 1. The FDA approves deramiocel from Capricor for Duchenne muscular dystrophy. You never know on these things and it could be 2027, but there are multiple reasons to think this approval is likely.
• 2. The agency approves at least two total cell therapies in 2026. At least one will be based on limited clinical trial data and no Phase 3 data.
• 3. We hear more about RFK Jr.’s views or actions on oversight of stem cells. This possibly will include lowering regs on stem cells or other kinds of cell therapies. He might mention support of a past or future state or federal law on stem cells.
• 4. Interestingly, despite potentially softer oversight in our field, CBER continues to issue a fairly steady stream of warning letters in 2026 including especially in the perinatal space and to stem cell clinic and supplier-type firms. It could be less than 2025, but I expect we’ll see at least 4 and probably more.
• 5. More top FDA departures, potentially even Makary exiting.
• 6. Look out for key buzzwords of historic change on biologics and related products at the FDA: plausible mechanisms, N=1, bespoke, and real-world data. The odd thing is that using these to speed up approvals doesn’t seem to really fit the world vision of CBER Director Vinay Prasad. Along those lines we’ll more broadly continue to see big contradictions at the FDA in terms of strictness and laxness. We might call this the Prasad Paradox.
• 7. Buzzword concepts twisted. Some potentially logical approvals based on the key concepts in #6 will happen, but we’ll see firms arguably twist or break the spirit of those words to aim for and maybe get approvals with less data. For example, the term “bespoke therapy” will likely to be applied to investigational approaches that maybe don’t exactly fit into that category. The idea of plausible mechanism may also be distorted. Maybe by the FDA itself.

Peptide fad: more people hurt, yet less regulation

• 8. The FDA somehow makes unproven peptide compounding and marketing easier driven by RFK Jr.’s interest in peptides. Note that these influencer-promoted peptides have little clinical trial data behind them. In some cases, essentially all the data are from in vitro studies of cells and animal studies. Peptides like BPC-157 have definite risks. The mechanism of easing peptide access is likely going to be through enforcement discretion on peptide compounding as two GOP lawmakers recently requested.
• 9. I expect an interesting dualism here with peptides and the FDA. As I said, we’ll likely see the agency open the door to more peptide compounding, but at the same time I predict we’ll see at least one or two warning letters or other oversight actions (e.g. on Chinese imports) on certain sources of peptides too. There’ll be a tension here between these actions. As mentioned in #6 above, this will continue to be an FDA that seems inconsistent.
• 10. At least one more incident of peptides causing harm comes to light.

State stem cell laws & AG actions; another area of tension

• 11. Problems arise related to the Florida stem cell law that says FDA approval is not needed for use of certain stem cell drugs in the state. This law conflicts with federal law and guidance from the FDA. The problems here could be harm to customers or issues related to state or federal actions.
• 12. At least one more state produces a new stem cell bill or passes a law saying FDA approval is not needed for marketing of certain cell therapies, probably mentioning “stem cells” or some other regenerative biologics.
• 13. More AG activity on unproven stem cells or biologics. The list of AG successes on clinics is growing. Iowa won another stem cell case for $1M in 2025. This will continue in 2026.
• 14. At least one more set of criminal charges in the regenerative space too. I recently wrote about three charged with felonies in Utah.

Human embryos and embryo models

• 15. More exciting science on the human embryo model front.
• 16. Probably also more drama here, possibly from Jacob Hanna and Magdalena Zernicka-Goetz. How about a co-authored policy paper from these two in favor of reasonable changes like a 28-day limit to human embryo growth in the lab and maybe the same limit for models too? It’d be great to see such a paper unambiguously say no pregnancies should be initiated from human embryo models.

Longevity, de-extinction hype

• 17. We hear more about the Bryan Johnson longevity experience. I wouldn’t be surprised to see him involved in a start-up in this space.
• 18. We’ll probably hear more from Harvard Professor David Sinclair as well about longevity. I’m curious to see what he publishes in 2026 too in the way of research.
• 19. And surely there will be more about body or epigenetic clocks that claim to measure aging. Will Shift Biosciences reveal the identity of their secret anti-aging gene SB000? Will the community think it is cool or hype?
• 20. More de-extinction hype. If you think about it, de-extinction research is the ultimate in longevity research of a kind. Dead? It doesn’t matter, we’ll bring you back. De-extinct you. Fact-checks are important here. After all these years, I still think de-extinction of a woolly mammoth has almost no pros but would be full of cons. De-extinction of dire wolves didn’t really happen. Colossal Biosciences got my The Screamers Science Hype Award last year for overstating what they achieved.

CRISPR babies, genetic optimization, & eugenics

• 21. Cathy Tie and her Manhattan Project make more news on the gene-edited babies goal. Will they find a high-profile bioethicist to help them navigate these difficult waters? I don’t know.
• 22. Eugenics is discussed more openly as a supposed good thing, perhaps by tech bros & politicians. In this spirit, others talk breathlessly about making gene-edited babies not just to try to prevent genetic diseases.
• 23. Nucleus Genomics, a firm claiming to already be able to use elective IVF and polygenic risk scoring-type analyses to optimize future babies, keeps making news along with its main competitors. Probably not all of the news will be positive.

Regenerative biotech space & stocks

What about stem cell stocks?

• 24. Polarized cell therapy stocks in 2026. Granted or expected FDA approvals in the broad regenerative space will lift a few stocks far higher this year. We saw that with Mesoblast after it got FDA approval. Capricor could be similar in 2026 and is already way up in part in anticipation. Do you have favorite cell therapy/regenerative stocks for 2026 and why?