Sarepta Therapeutics Is Already Down 84% This Year. And The Other Shoe Just Dropped.
Sarepta stock dropped again Wednesday after the FDA announced it's investigating the deaths of two patients who received Elevidys.
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Business Wire
an hour ago
- Business Wire
Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. About Aurinia Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Miami Herald
7 hours ago
- Miami Herald
An acid reflux drug got recalled. Company says bottles might have different meds
One lot of reflux medicine got recalled when fluid retention tablets were discovered in the medicine bottles. Teva Pharmaceuticals pulled lot No. 5420094 of 10 mg Metoclopramide tablets in 100-count bottles after 'a single 20 mg Torsemide tablet that does not belong was discovered in each of three individual sealed bottles of 10 mg Metoclopramide tablets.' It comes from the Teva press release posted to the company website that the FDA apparently missed when it stated 'press release not issued for this recall' under the press release URL part of the FDA's enforcement alert. Metoclopramide treats reflux symptoms in adults after failure of normal treatments. 'Torsemide is used to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease,' the Mayo Clinic said. READ MORE: Broward drug company recalls 3 eye drugs that might not be sterile The FDA classified this as a Class II recall, meaning problems caused by this mixup shouldn't last long, and there's a 'remote' chance of serious problems. '...the likelihood of an unintended drug reaction occurrence is remote/unlikely as Metoclopramide tablets will not be dispensed in the original packaging but will be divided at the pharmacy level,' Teva said. 'and be dispensed in smaller quantities for patient use, where the difference in tablets is likely to be noticed by the pharmacist.' 'Likely' although there's not much difference in how each medication looks. Teva says the 10 mg Metoclopramide tablets are white, round, dividing line on one side, '2203' above the divider on that side and 'TEVA' on the other side. The National Library of Medicine describes the 20 mg Torsemide tablets are white, round, dividing line on one side with '917' above the divider. The Metoclopramide tablets are 8 millimeters in size, while the Torsemide tablets are 10 millimeters. For instructions on how to return the recalled lot, which has an expiration date of 9/2027, go to Teva's online consumer recall letter. Direct questions about this recall to 888-838-2872, option 4, Monday through Friday, 9 a.m. to 5 p.m., Eastern time to speak to a person. Voice mail works 24 hours a day. If you have a medical problem because you think a wayward Torsemide tablet was taken by a Metoclopramide user, call a medical professional. Then, notify the FDA MedWatch adverse event program. Third, call Teva at 888-838-2872, option 3, then option 4, Monday through Friday, 9 a.m. to 5 p.m., Eastern time, or email USMedInfo@
Politico
8 hours ago
- Politico
RFK Jr. is bringing psychedelics to the Republican party
Driven by a desire to help ex-servicemembers with mental illness, GOP lawmakers led a failed campaign last year to persuade the Biden administration to approve psychedelic drugs. Now they may have found the ally they need in President Donald Trump's health secretary, Robert F. Kennedy Jr. A longtime believer in psychedelics' potential to help people with illnesses like post-traumatic stress disorder and depression, despite the lack of supportive evidence Biden officials found, Kennedy is ramping up government-run clinical studies and telling the disappointed lawmakers doctors will be prescribing the drugs soon. 'These are people who badly need some kind of therapy, nothing else is working for them,' Kennedy said at a House hearing Tuesday. 'This line of therapeutics has tremendous advantage if given in a clinical setting. And we are working very hard to make sure that that happens within 12 months.' The GOP's embrace of psychedelics is another, and perhaps one of the more jarring, examples of cultural transformation that Trump's populist politics have brought. Veterans seeking cures for mental illnesses associated with combat, combined with the Kennedy-backed Make America Healthy Again movement's enthusiasm for natural medicine, have strengthened a libertarian strain on the right in favor of drug experimentation. Meanwhile, the left, where hippies are giving way to technocrats, has become more skeptical. When Joe Biden was president, for example, agencies studied the drugs' medical potential, but an air of doubt prevailed. The head of the National Institute on Drug Abuse, Nora Volkow, compared the hype for psychedelics as a cure for mental illness to belief in 'fairy tales' in Senate testimony last year. Then in August, the Food and Drug Administration rejected drugmaker Lykos Therapeutics' application to offer ecstasy, alongside therapy, as a treatment for PTSD. FDA advisers worried the company's researchers were more evangelists than scientists and determined that they'd failed to prove their regimen was either safe or effective. Republicans complained the loudest. 'These technocrats think they know better,' Texas GOP Rep. Dan Crenshaw, a former Navy SEAL who lost an eye in Afghanistan, wrote on X after FDA advisers recommended Lykos' application be rejected. 'Their job is to say NO and support the status quo.' But Crenshaw, who's helped secure funding for psychedelic research at the Defense Department, got the response he wanted from Kennedy at Tuesday's budget hearing. Kennedy said results from early government studies at the Department of Veterans Affairs and FDA were 'very, very encouraging.' He added that his FDA commissioner, Marty Makary, sees it the same way. 'Marty has told me that we don't want to wait two years to get this done,' he said. Crenshaw was pleased. 'I've spent years supporting clinical trials to study the use of psychedelics to treat PTSD,' he told POLITICO. 'It's been a long fight, and it's taken a lot of grit. I'm grateful Secretary Kennedy is taking this seriously — helping to mainstream what could be a groundbreaking shift in mental health.' Kennedy's comments have revived hope among psychedelics' advocates that the Lykos decision was more hiccup than death knell. 'It's important for the entire community and the entire value chain around psychedelic therapy to hear that he wants to responsibly explore the benefits and risks of these therapies,' said Dr. Shereef Elnahal, a health official at the VA under Biden who sees promise in the drugs. The VA, under Trump's secretary, Doug Collins, is working directly with Kennedy on clinical research. Collins has referenced psychedelics on a podcast appearance, on X and at a cabinet meeting this spring when Trump pressed him on what he's doing to drive down the high suicide rate among veterans. 'I talk with Collins about it all the time,' Kennedy said Tuesday. 'It's something that both of us are deeply interested in.' Earlier this month, Texas' Republican governor, Greg Abbott, signed a law to put $50 million into clinical trials of the psychedelic ibogaine, as a mental health treatment. 'That culture shift is underway,' W. Bryan Hubbard, who spearheaded the Texas bill and is executive director of the American Ibogaine Initiative, told POLITICO. As Hubbard sees it, the narrative around psychedelics has evolved from counterculture recreation to a promising medical treatment for the 'deaths of despair' from alcohol, drug overdoses and suicides the United States has grappled with in recent decades. Kennedy was happy to see it. 'It's super positive. It is really notable that the Republicans have become the party of some of these issues you wouldn't have expected before,' Calley Means, a top Kennedy adviser, told POLITICO. 'States pushing the envelope is certainly aligned with what Secretary Kennedy is trying to do. It gives him leverage to push bolder reforms.' The Texas effort involved a six-month sprint by Hubbard and former GOP Gov. Rick Perry to convince state lawmakers to pass the bill. Rep. Morgan Luttrell, another Lone Star Republican who credits ibogaine he took in Mexico with helping him overcome trauma he incurred during military service, also lobbied for it. Hubbard attributes their success partly to Texas' independent pioneer culture and a red-state philosophy that was receptive to his pitch for a medicalized psychedelics model. It didn't hurt that Abbott had signed a bill to study ecstasy, psilocybin and ketamine as treatments for veterans with PTSD with Baylor College of Medicine. And since Texans are no stranger to religion, conversations about the spiritual aspect of ibogaine treatment seemed to resonate with lawmakers. 'We had a message that was tailor-made for the Lone Star State,' he said. Veterans turned out at public hearings to describe traveling out of the country, often to Mexico, where ibogaine is unregulated, to receive treatment they couldn't access in the U.S. 'These heroes have gone to war to defend the land of the free, only to come home and be faced with inflexible, bureaucratic systems that offer ineffectual solutions, paired with the Controlled Substances Act that has forced them to flee the country that they have defended in order to access treatment in a foreign country,' Hubbard said. But the biggest momentum push was likely the boost Hubbard and Perry got from conservative kingmaker Joe Rogan when the two went on Rogan's podcast in January. 'That really put a tremendous amount of wind in our sails,' Hubbard said. Still, last year's FDA decision to reject Lykos Therapeutics' application underscores the concerns raised by many scientists that the utility of the drugs is oversold. FDA advisers raised ecstasy's potential to damage the heart and liver; a suspicion that trial researchers were more advocates than scientists; and a worry that results had been skewed by the psychedelics' pronounced effects, since participants could figure out if they got the drug. Ibogaine also poses heart risks. The Drug Enforcement Administration lists both it and ecstasy on its schedule of drugs with no currently acceptable medical use and high risk of abuse. That would have once been enough to make law-and-order Republicans say no. Kennedy's adviser Means says things are changing for the better. 'Ten years ago, nobody expected the Republican Party as the party of healthy food, as the party of exercise, as the party of questioning pharmaceutical companies, as the party of psychedelic research — but that's where we are,' Means said. 'The Democratic Party has become the party of blindly trusting experts,' he concluded. 'The Republican Party has become the countercultural party that's asking common-sense questions.'
