Health
New drug for stiff person syndrome granted designation to speed up development: ‘Thrilled for the community’
Patients with stiff person syndrome are one step closer to having access to a new treatment.
Kyverna Therapeutics’ new drug, KYV-101, has been designated by the U.S. Food and Drug Administration (FDA) a Regenerative Medicine Advanced Therapy (RMAT), the company announced on Monday.
A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website.
STIFF PERSON SYNDROME PATIENTS SHARE WHAT IT’S LIKE TO LIVE WITH THE RARE DISEASE
One of the benefits of RMAT is that Kyverna will be able to work closely with the FDA to help support accelerated development, review and approval, according to the company.
The FDA’s decision was based on positive results from clinical trials with patients, a company press release stated.
Carrie Robinette, left, was diagnosed with stiff person syndrome in 2023. The FDA named KYV-101 a Regenerative Medicine Advanced Therapy (RMAT) on Monday. (Carrie Robinette; iStock)
A rare neurological disorder, stiff person syndrome affects only one or two people for every million — including singer Celine Dion.
The disease can have a devastating impact, causing muscle rigidity, pain, spasms and loss of mobility.
LIKE CELINE DION, PENNSYLVANIA MAN IS FIGHTING STIFF PERSON SYNDROME WITH ‘EVERYTHING I HAVE’
Kyverna Therapeutics, based in Emeryville, California, developed the new CAR-T cell therapy, KYV-101, with the goal of “resetting” the immune systems of patients with autoimmune diseases, according to the company.
“As a physician dedicated to optimizing diagnosis and treatments for patients with autoimmune neurological disorders, I am grateful to be able to witness and contribute to the advancement of treatments and patient outcomes in stiff person syndrome via collaborative research efforts with leading players in the field and the support of the FDA oversight,” Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus in Aurora, Colorado, told Fox News Digital via email.
Céline Dion shared her stiff person syndrome diagnosis with the world in Dec. 2022. (Edward Berthelot/GC Images/Getty Images)
Piquet was not involved in the development of KYV-101, but did take part in one of the medical advisory boards.
Peter Maag, PhD, CEO of Kyverna, also commented on the announcement.
“This RMAT designation means science agrees that fast-tracking this treatment could save lives.”
“Kyverna is focused on supporting patients and their clinical unmet needs, building patient-centric clinical trials to allow access to the latest medical advances in the CAR-T space for autoimmune disease,” Maag told Fox News Digital in a written statement.
“We are proud to be able to investigate the potential of safe and effective long-lasting treatment that can lead to meaningful, durable remission for patients suffering from autoimmune diseases like SPS.”
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Patients also reacted to the news with a sense of excitement.
“From the moment I learned what Kyverna’s treatment had done for the SPS patient in Germany, my dream was that it would get FDA-approved quickly so we could all benefit,” Carrie Robinette, 45, from San Diego, California, told Fox News Digital.
A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website. (REUTERS/Andrew Kelly/File photo)
Robinette, a Navy wife and mother, was diagnosed with stiff person syndrome in spring 2023.
“This RMAT designation means science agrees that fast-tracking this treatment could save lives,” she added. “I’m thrilled for the entire autoimmune disease community.”
During clinical trials, 50 patients with oncological and autoimmune conditions have been treated with KYV-101 in more than 15 locations in Europe and the U.S., according to the company.
Kyverna will now continue collecting data from the drug’s Phase 2 trials for stiff person syndrome, multiple sclerosis and myasthenia gravis.
Carrie Robinette, 45, from San Diego, California, at left, and Corwyn Wilkey, 44, who lives in Anchorage, Alaska, right, are both living with stiff person syndrome. (Carrie Robinette; Corwyn Wilkey)
Phase 1 and 2 trials are also underway for systemic sclerosis and lupus.
“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” Maag said in the company’s release.
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Added Piquet, “Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease … I look forward to the data that will emerge from the KYSA-8 trial, as this trial could drastically change the treatment landscape for SPS.”
Fox News Digital reached out to the FDA for additional comment.
Health
‘Weight Loss Has Never Been About Calories’: How This Low-Insulin Diet Helped Lillie, 58, Drop 70 Lbs!
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Health
Weight-loss experts predict 5 major treatment changes likely to emerge in 2026
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Big moves are continuing in the weight loss landscape in the new year following breakthrough research of GLP-1 medications and other methods.
Weight-loss experts spoke with Fox News Digital about their predictions for the most major changes to come in 2026.
No. 1: Shift to whole-body treatment
Dr. Peter Balazs, a hormone and weight loss specialist in New York and New Jersey, shared that the most important shift is likely to label GLP-1 drugs as “multi-system metabolic modulators” rather than “simple weight loss drugs.”
MORE AMERICANS MAY BE CLASSIFIED AS OBESE UNDER NEW DEFINITION, STUDY SUGGESTS
“The treatment goal is no longer just BMI reduction, but total cardiometabolic risk mitigation, with effects now documented across the liver, heart, kidneys and vasculature,” he said.
“We are seeing a significant reduction in major adverse cardiovascular events … and progression of renal disease,” he went on.
The focus of GLP-1 drugs will widen beyond weight loss and diabetes, according to experts’ predictions. (iStock)
Philip Rabito, M.D., a specialist in endocrinology, weight loss and wellness in New York City, also shared that “exciting” advancements lie ahead for weight-loss drugs, including GLP-1s and GIPs.
OLDER AMERICANS ARE QUITTING GLP-1 WEIGHT-LOSS DRUGS FOR 4 KEY REASONS
“These next‑generation agents, along with novel combinations that include glucagon and amylin agonists, are demonstrating even more impressive weight‑loss outcomes than currently available therapies, with the potential for better tolerability and sustained results,” he told Fox News Digital.
“There is also tremendous optimism around new federal agreements with manufacturers that aim to make these medications more widely accessible and affordable for the broad population of patients who need them most.”
No. 2: More convenient dosing
The typical prescription for a GLP-1 medication is a weekly injection, but delivery and dosing may be changing to more convenient methods in 2026, according to Balazs.
OPRAH JOINS WAVE OF CELEBRITIES WHO REVEALED DRAMATIC WEIGHT LOSS IN 2025
A daily 25 mg pill version of Novo Nordisk’s Wegovy, a semaglutide designed to treat obesity, is now approved and available for chronic weight management, offering a non-injectable option for some patients.
A once-weekly oral GLP-1 is currently in phase 2 trials, as well as an implant that aims for three to six months of drug delivery, Balazs noted.
Incisionless weight-loss procedures will rise as a lower-risk option, according to experts. (iStock)
No. 3: Less invasive surgery
In addition to decreased risk during surgery for GLP-1 users, Balazs also predicted that metabolic surgery without incision will rise as a better option.
“Incisionless endoscopic procedures — like endoscopic sleeve gastroplasty (non-surgical weight-loss procedure that makes the stomach smaller from the inside) and duodenal mucosal resurfacing (non-surgical procedure that resets part of the small intestine to help the body better handle blood sugar) — [may become] more durable and widely available,” he said.
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“These offer significant metabolic benefits with shorter recovery and lower risk than traditional surgery.”
Rabito agreed that “rapid progress” in minimally invasive weight‑loss procedures is “opening powerful new options for patients who are hesitant to pursue traditional bariatric surgery.”
Bariatric surgery remains the most effective weight loss method, one specialist says. (iStock)
This avenue offers “meaningful and durable weight reduction with less risk, shorter recovery times and no external incisions,” the expert added.
Dr. Muhammad Ghanem, bariatric surgeon at the Orlando Health Weight Loss & Bariatric Surgery Institute, reiterated that surgery remains “the most successful modality for the treatment of obesity … with the highest weight loss and most durable outcomes as of yet.”
No. 4: Younger GLP-1 users
As Novo Nordisk’s Wegovy has been indicated for adolescents over 12 years old as an obesity treatment, Balazs commented that pediatric use of weight-loss drugs is “now a clinical reality.”
He predicted that other alternatives are likely to be approved in 2026 for younger users.
No. 5: High-tech, personalized access
Amid the growth of artificial intelligence, Balazs predicted an expansion in the clinical implementation of AI-driven weight-loss methods.
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This could include categorizing obesity into sub-types like “hungry brain,” “emotional hunger” and “slow burn” to personalize how therapy is prescribed while moving away from “trial and error,” he said.
Ghanem agreed that there will likely be a “big focus” on individualized testing for causes of obesity in 2026, as it’s a disease that can have “different causes in different people,” thus requiring different treatments.
AI and other digital opportunities will drive more access for weight-loss patients, experts say. (iStock)
The doctor anticipates that more patients will seek combinations of comprehensive treatments and programs.
“Patients are more aware that now we have a few weapons in our arsenal to combat obesity, and [they] are seeking a multidisciplinary and holistic approach,” Ghanem said.
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Treatment options will also turn digital with the rise of prescription digital therapeutics (PDTs) for weight loss, Balazs predicted.
“These are software applications delivering cognitive behavioral therapy, personalized nutrition and metabolic coaching through algorithms, often integrated with continuous glucose monitors, and reimbursed as medical treatments,” he said.
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Ghanem added that body composition analyzers, like DEXA scans, will likely be more widely used as awareness grows about the limitations of BMI and weight in assessing obesity.
Health
Brain Health Challenge: Doctor Appointments for Your Mind and Body
Congratulations, you’ve reached the final day of the Brain Health Challenge! Today, we’re asking you to do a few things that might feel a bit out of left field — like getting your blood pressure checked.
No, it isn’t as fun as playing Pips, but experts say it’s one of the most important things you can do for your brain. That’s because heart health and brain health are intrinsically linked.
High blood pressure, in particular, can damage brain cells, and it’s a significant risk factor for stroke and dementia. When blood pressure is too high, it places stress on the walls of arteries in the brain. Over time, that added stress can cause the blood vessel walls to thicken, obstructing blood flow. In other cases, the increased pressure causes the artery walls to thin and leak blood into the brain.
These changes to the blood vessels can sometimes cause a large stroke to occur. More commonly, the damage leads to micro-strokes and micro-hemorrhages, which cause fewer immediate problems and often go unnoticed. But if someone has hypertension for years or decades, these injuries can build up, and the person may start to experience cognitive impairment.
High blood pressure “is known as a silent killer for lots of reasons,” said Dr. Shyam Prabhakaran, the chair of neurology at the University of Chicago. “It doesn’t cause you any symptoms until it does.”
Because the damage accumulates over many years, experts say that managing blood pressure in midlife matters most for brain health. Hypertension can be addressed with medication or lifestyle changes, as directed by your doctor. But the first thing you need to do is know your numbers. If your blood pressure comes back higher than 120/80, it’s important to take it seriously, Dr. Prabhakaran said.
While you’re at it, there are a few other aspects of your physical health that you should check on.
Your eyes and ears are two of them. Hearing and vision loss have both been shown to increase the risk of dementia. Experts think that with less sensory information coming in to stimulate the brain, the regions that process hearing and vision can start to atrophy. What’s more, people with sensory loss often withdraw or are left out of social interactions, further depriving them of cognitive stimulation.
Oral health can also affect your brain health. Research has found a connection between regular flossing and reduced odds of having a stroke. That may be because good oral health can help to reduce inflammation in the body. The bacteria that cause gum disease have also been tied to an increased risk of Alzheimer’s.
And have you gotten your shingles vaccine? There is mounting evidence that it’s a powerful weapon for protecting against dementia. One study found that it lowered people’s odds of developing the condition by as much as 20 percent.
To wrap up this challenge, we want you to schedule a few medical appointments that benefit your brain, as well as your body.
After five days of feeding, exercising and challenging your brain, you are well on your way to better cognitive health. Thanks for joining me this week, and keep up the good habits!
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