What is the deal with Sarepta lately? Things are spiraling.
Before we dig into that, let’s give a RIP to Ozzy Osbourne, who had struggled with health issues. He was one of dozens of celebs to turn to unproven stem cells.
Also, a heads up that student and stem cell researcher Parmin Sedigh and I have a new educational video on stem cells and brain health. This one is on stem cells for dementia including Alzheimer’s disease as well as Parkinson’s. Check it out below and please subscribe to her channel as well as my stem cell YouTube channel.
Sarepta roller coaster mostly going down
Okay, back to Sarepta, which has been all over the news.
Three patient deaths related to gene therapies.
Conflicts with the FDA. First, it seemed they were going to defy the FDA on the gene therapy Elevidys. It’s for Duchenne muscular dystrophy.
Then they backed down.
Now a key EMA committee has rejected Elevidys.
What might the road back from this chaos be like for Sarepta?
BrainStorm Cell Therapeutics at risk
Speaking of regenerative biotechs in tough spots, we have this: BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB, PR. The company could have gotten a recent boost when patients asked the FDA to approve its cell therapy drug Nurown for ALS. However, things just keep getting worse including with a Nasdaq delisting. Never a good thing.
I don’t invest in stem cell stocks. I think I’ve own a couple over the period of 15 years and only for a very short time in each case. Even so, I follow a few dozen stem cell stocks (meaning cell therapy and regenerative medicine stocks). Some of this is more my interest in what the company in question is doing more than being upbeat about their prospects. I’m also interested in why some biotechs do well and others struggle or even die.
Even those that struggle, like Celularity (Down 96% in the last 5 years) sometimes hang around and there’s always the chance of a comeback. Recently, it seems Celularity is hoping for a comeback based on supplying placental cells to those who may want to market them under the new Florida stem cell law. Other firms are also excited about the Sunshine State law. Maybe the feds won’t challenge it?
More recommended reads
- The Peptide Craze, Eric Topol’s Substack. This is a helpful overview of how people have gone way over the top on unproven peptides. I recently wrote about BPC-157. Recall that in the same tweet where he said the FDA had been suppressing stem cells, RFK Jr. also mentioned “peptides.”
- Denise Richards’ Ex Aaron Called Out by Man Suing Him Over Alleged Fraud, MSN. A lot of drama here. Rupert Perry made accusations against Aaron Phypers related to stem cells: “As Us previously reported, Perry sued Phypers over payments his late wife, Elina Katsioula-Beall, made over stem cell treatments at Phypers’ now-closed wellness center, Quantum 360 Club.” Why am I writing about this? The club sounds like it was an unproven stem cell clinic or something similar. It’s also troubling that reportedly some kind of stem cells were sold to Katsioula-Beall for her sarcoma. To my knowledge, there is no approved stem cell treatment for sarcoma. Keep in mind, as best as I can tell, we’re not talking about hematopoietic stem cells after chemo for immune system reconstitution here.
- NIH, FDA plan to reduce animal testing draws mixed reactions among scientists, STAT News.What does this mean for funding of research on models like rodents?
- FDA’s New Drug Approval AI Is Generating Fake Studies, Gizmodo. And AI is one of the things that is supposed to replace real experienced people at the agency?