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
One walking habit could signal a healthier brain after 80, scientists say
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Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers.
That’s according to a recent study led by Stony Brook Medicine in New York, which evaluated the cognitive function of 4,000 adults 80 and over who participated in multiple aging and longevity studies over several years.
Among this group, 6% to 10% were classified as super movers, which means they walk at a much faster pace than others of the same age and gender — at speeds comparable to people three decades younger.
COMMON VITAMIN MAY INFLUENCE BRAIN AGING IN WAYS SCIENTISTS DIDN’T EXPECT
The super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed.
The findings were published in the journal Neurology on June 16.
Older adults identified as “super movers” are about half as likely to develop cognitive impairment than their peers. (iStock)
“The study reinforces that mobility and brain health are closely connected,” lead study author Dr. Joe Verghese, MD, neurologist at Stony Brook Medicine, told Fox News Digital. “This suggests that preserving mobility may be an important marker of healthy brain aging and resilience.”
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The most intriguing finding, according to Verghese, was that super movers maintained cognitive function despite having similar dementia-related brain changes as their peers.
In postmortem brain analysis, there was no difference in dementia-related pathologies between the super movers and the slower walkers, the study stated.
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“This suggests they may possess resilience mechanisms that help preserve brain function even in the presence of age-related changes,” he said. “Understanding these resilience factors could lead to new strategies for promoting healthy brain aging.”
As the study was observational, there were some limitations, and it does not prove that walking faster prevents dementia, the researchers noted.
Super movers were found to have about half the risk of cognitive decline compared to seniors with typical gait speed. (iStock)
“Other factors, such as cardiovascular health, physical fitness or genetics, may also contribute to both faster walking and better cognitive outcomes,” Verghese said.
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This study adds to growing evidence that what’s good for the heart and muscles also benefits the brain, he noted, adding that “staying physically active remains one of the most effective, evidence-based ways to support healthy aging.”
“Walking speed is best viewed as a marker of overall health, not a treatment.”
“The broader message is that physical activity is important at any age,” Verghese said. “Walking is an easy step-up point because you don’t need any special equipment. You can do it inside or outdoors, and you can do it on a regular basis. You can walk with a dog, you can walk with a friend.”
Any activity is beneficial if it’s done regularly and with the right intensity, he added.
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Rather than just trying to walk faster, the neurologist recommends that seniors focus on maintaining mobility through regular physical activity, strength training, balance exercises and good cardiovascular health.
“Walking speed is best viewed as a marker of overall health, not a treatment,” Verghese noted.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking.
Major public health guidelines from the CDC and U.S. Physical Activity Guidelines recommend at least 150 minutes of moderate-intensity aerobic activity each week, such as brisk walking. (iStock)
This can be achieved by walking 30 minutes a day, five days a week, or about 20 to 25 minutes most days. Another option is to engage in shorter sessions that add up over the day.
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“You have to do it within your health limitations and medical conditions,” Verghese advised. “So if there are any medical concerns, I would get your physician to clear you before starting exercise.” The good thing about walking, he added, is that you can start at a slow pace and then gradually build up to a brisker pace.
“And then adding on strength and balance training, whatever age you are, I think is also important.”
Health
I Tried the Viral Gelatin Weight-Loss Recipe—Here’s My Honest Take
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Health
Dr Oz warns Medicare scammers are stealing billions — and your personal information could be next
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Washington, D.C. – Medicare fraud is a multibillion-dollar problem that government officials say threatens both taxpayer dollars and Americans’ personal identities.
In a July 6 interview with Fox News Digital at the Great American State Fair in Washington, D.C., Dr. Mehmet Oz warned that every dollar stolen through Medicare fraud is a dollar taxpayers lose – a problem that has worsened since the COVID pandemic.
“If I had to just pick one thing to focus on to make healthcare more affordable in America, I’d go to health fraud and all the waste and abuse that accompanies it,” said Oz, who is the administrator of the Centers for Medicare & Medicaid Services. “And just to put this in perspective, we think it’s about $100 billion a year.”
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Medicare fraud can include billing for services that were never provided, overcharging for medical equipment, using stolen patient or doctor information, or performing unnecessary procedures, according to the U.S. Government Accountability Office.
CMS administrator Dr. Mehmet Oz is pictured on stage at the Great American State Fair in Washington, D.C., on July 6, 2026. (Angelica Stabile/Fox News Digital)
As the Trump administration ramped up efforts to combat fraud, CMS reported $41.9 billion in Medicare program integrity savings in 2025, up 59% from $26.3 billion in 2024.
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Medicare fraud not only harms the federal budget and steals from taxpayers, but exposes seniors to identity theft, unnecessary care, higher premiums and reduced access, Oz cautioned.
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Removing corruption from the healthcare system will have the greatest impact among seniors, since “so much of the fraud is perpetrated against them,” the administrator said.
“I’m talking about people tricking seniors to give up their Medicare beneficiary numbers, which is like a credit card basically,” he said. “These scammers can take those numbers and use them for all kinds of illegitimate purposes.”
“If I had to just pick one thing to focus on to make healthcare more affordable in America, I’d go to health fraud and all the waste and abuse that accompanies it,” said Oz. (Fox News Digital)
“People are stealing from you by pretending to send you drugs you don’t want, wheelchairs you don’t need, [and] services you never asked for or don’t benefit from,” Oz added.
To prevent this, he shared his top advice for seniors: Do not give your Medicare beneficiary number to anybody, do not answer questions on a phone call from an unknown person and do not give away personal information.
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“These scammers are calling seniors, tricking them, and once they have key information, they can steal it,” he said. “And I won’t know it and you won’t know it.”
“We want to protect people who need these programs the most,” Oz went on. “You do that by making sure scoundrels don’t corrupt the systems and steal money out of the till that is designed to help folks in dire straits when they’re vulnerable and in need of services.”
Seniors should never share their Medicare information with unknown people, the administrator advised. (iStock)
Removing fraud could “double the life expectancy of the trust fund that makes all this possible,” Oz predicted.
“If you’re worried about Medicare being there when you’re ready to retire in a couple decades, depending on how old you are, and you’re concerned that it might not last because of all the fraud that’s hitting it … you’ve got a good [reason to] worry,” he said.
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“If we take the fraud out, we could double the life expectancy, which means you, your kids, your kids’ kids … they could all benefit from this beautiful safety net program.”
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