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BioCity's SC0062 gains NMPA breakthrough therapy designation
BioCity's SC0062 gains NMPA breakthrough therapy designation

Yahoo

time3 days ago

  • Health
  • Yahoo

BioCity's SC0062 gains NMPA breakthrough therapy designation

The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted BioCity's endothelin receptor type A (ETA) antagonist, SC0062, a second breakthrough therapy designation (BTD). This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy's potential for chronic kidney disease indications. The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo. The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone. BioCity co-founder and executive president Dr Ivy Wang stated: 'With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges. 'This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide.' The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts. SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects. Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models. The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention. It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints. With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). "BioCity's SC0062 gains NMPA breakthrough therapy designation" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 登入存取你的投資組合

Canaccord Genuity Maintains a Buy on Inventiva (IVA) With a $20 Price Target
Canaccord Genuity Maintains a Buy on Inventiva (IVA) With a $20 Price Target

Yahoo

time5 days ago

  • Business
  • Yahoo

Canaccord Genuity Maintains a Buy on Inventiva (IVA) With a $20 Price Target

Inventiva S.A. (NASDAQ:IVA) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. Analyst Edward Nash from Canaccord Genuity maintained a Buy rating on Inventiva S.A. (NASDAQ:IVA) on June 5, keeping the price target at $20.00. The rating was based on several factors, including the potential of lanifibranor, the company's lead asset in the MASH space. Lanifibranor's oral administration and direct anti-fibrotic effects distinguish it from other treatments in development, with a primary focus on liver fat reduction. A research scientist in an idiopathic pulmonary fibrosis laboratory, carrying out clinical trials. The analyst also reasoned that Lanifibranor can be used in conjunction with other treatments, including GLP-1s and SGLT2 inhibitors. This factor is a significant boost to its appeal, especially when considering the high prevalence of type 2 diabetes in MASH patients. Nash stated that the drug is progressing well, which can be corroborated by the completion of full enrollment in the Phase III NATiV3 trial and the anticipated top-line data in H2 2026. Major pharmaceutical companies are also showing increasing interest in the MASH space, further supporting the optimistic outlook for Inventiva S.A. (NASDAQ:IVA). Inventiva S.A. (NASDAQ:IVA) is a clinical-stage biopharmaceutical company that develops oral small-molecule therapies to treat non-alcoholic steatohepatitis or NASH. It also develops therapies for other diseases with considerable unmet medical needs. While we acknowledge the potential of IVA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

The European Commission Approves Alnylam's AMVUTTRA
The European Commission Approves Alnylam's AMVUTTRA

Yahoo

time13-06-2025

  • Business
  • Yahoo

The European Commission Approves Alnylam's AMVUTTRA

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is one of the 13 Biotech Stocks with Huge Upside Potential. It declared on June 9, 2025, that AMVUTTRA® (vutrisiran) has been approved by the European Commission to treat wild-type or hereditary ATTR amyloidosis with cardiomyopathy (ATTR-CM). A researcher studying genetic medicines under a microscope in a biopharmaceutical laboratory. As a result, AMVUTTRA is the first and only RNAi treatment approved in the EU for transthyretin amyloidosis symptoms that show as cardiomyopathy and polyneuropathy. The HELIOS-B Phase 3 research, which revealed a 36% mortality reduction over 42 months and a 28% decrease in all-cause mortality and recurrent cardiovascular events, served as the basis for the approval. More than 6,000 patient-years of safety data support the quarterly administration of the medication. The drug is already authorized in Brazil and the United States. Up to 100,000 individuals in Europe have ATTR amyloidosis, mostly as cardiomyopathy. An RNAi treatment called vutrisiran provides continuous knockdown by stopping TTR production at its source with quarterly injections. Functional and quality-of-life gains were validated by the HELIOS-B trial, which involved patients on SGLT2 inhibitors and tafamidis. Elevations of liver enzymes and injection site responses are frequent adverse effects. Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is an innovator in the investigation of RNA interference medicines. While we acknowledge the potential of ALNY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

SGLT2 Inhibitors May Offer Better Delirium Protection in T2D
SGLT2 Inhibitors May Offer Better Delirium Protection in T2D

Medscape

time12-06-2025

  • Health
  • Medscape

SGLT2 Inhibitors May Offer Better Delirium Protection in T2D

In adults with type 2 diabetes (T2D), the use of SGLT2 inhibitors was associated with lower risks for delirium and all-cause mortality than the use of metformin, with more prominent protective effects in high-risk patients such as those aged 80 years or older. METHODOLOGY: T2D is a recognized risk factor for delirium. Although several studies have shown neuroprotective effects of metformin and cognitive protection by SGLT2 inhibitors, a real-world comparative analysis is lacking. Researchers conducted a retrospective cohort study using data from electronic health records of healthcare organizations worldwide for a head-to-head comparison of metformin and SGLT2 inhibitors in preventing delirium among patients with T2D. After propensity score matching, they included adults with T2D who initiated either SGLT2 inhibitors (n = 79,723; mean age, 65.52 years; 39.77% women) or metformin (n = 79,723; mean age, 65.62 years; 39.43% women) between January 2005 and January 2025. The primary outcome was the first recorded diagnosis of delirium, and the secondary outcome was all-cause mortality. TAKEAWAY: The use of SGLT2 inhibitors was associated with a lower risk for incident delirium than the use of metformin (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.87-0.95). The risk for all-cause mortality was also reduced in patients who used SGLT2 inhibitors (aHR, 0.85; 95% CI, 0.87-0.88). The protective effect of SGLT2 inhibitors against delirium was most prominent in patients aged 80 years or older (aHR, 0.83; P < .0001), men (aHR, 0.94; P = .0131), White patients (aHR, 0.90; P < .0001), and patients with better glycemic control with A1c levels between 5% and 6.49% (aHR, 0.91; P = .0212). < .0001), men (aHR, 0.94; = .0131), White patients (aHR, 0.90; < .0001), and patients with better glycemic control with A1c levels between 5% and 6.49% (aHR, 0.91; = .0212). Among patients who used SGLT2 inhibitors, the use of medicines such as insulin, sulfonylureas, antiepileptics, and sedatives was also associated with a significantly reduced risk for delirium ( P < .05 for all). IN PRACTICE: 'By leveraging real-world data on an unprecedented scale, this study not only bridges a critical knowledge gap but also paves the way for a paradigm shift in first-line diabetes management, prioritizing both metabolic and neurocognitive health,' the study authors wrote. SOURCE: This study was led by Mingyang Sun and Xiaoling Wang, Department of Anesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital in Zhengzhou, China. It was published online in Diabetes Care . LIMITATIONS: The researchers relied on diagnostic codes which may have missed milder cases of delirium, especially those managed outside hospital settings. The presence of residual confounding factors could not be completely ruled out. Information on neurocognitive markers was absent, which restricted the understanding of the neuroprotective effects of SGLT2 inhibitors. DISCLOSURES: This study was supported by grants from National Key Research and Development Program of China, National Natural Science Foundation of China, and Lo-Hsu Medical Foundation, Lotung Poh-Ai Hospital. The authors reported having no conflicts of interest.

These diabetes drugs are finding new life as an antiaging hack
These diabetes drugs are finding new life as an antiaging hack

Mint

time12-06-2025

  • Health
  • Mint

These diabetes drugs are finding new life as an antiaging hack

Some health-obsessed Americans believe the next antiaging therapeutic already exists—in the medicine cabinets of millions of diabetes patients. The widely used class of drugs, called SGLT2 inhibitors and sold under brand names such as Jardiance and Farxiga, have been on the market for over a decade as Type 2 diabetes medications. They have also gained regulatory approval to treat conditions like heart failure and kidney disease. Recently, though, the drugs have emerged as a hot topic on popular health podcasts and Reddit forums for longevity enthusiasts, many of whom don't suffer from any of those conditions. Instead, they are adding SGLT2 inhibitors to a roster of hacks they hope will help them live healthier for longer—or in other words, increase their healthspan. The drugs work by helping the kidneys release extra glucose from the body through urine, improving blood-sugar levels. While there are no studies of whether they can extend the lives of healthy humans, a growing body of evidence shows they help protect against multiple age-related diseases and reduce mortality rates for patients with certain chronic conditions. Some researchers believe they may also affect the fundamental biology of aging. 'This is probably the drug class of our era," says Dr. Timothy Gong, section physician leader for heart failure and transplant cardiology at Baylor University Medical Center, who has researched SGLT2 inhibitors. 'You see cardiologists, nephrologists, endocrinologists, even general internists as well, just getting so excited." Gong says he wouldn't be surprised to take an SGLT2 inhibitor one day, once they are studied more, though he's free from heart issues and diabetes. Yet it's too early to prescribe it for longevity benefits in otherwise healthy patients. 'I don't think that the evidence is strong enough yet for us to be able to say that," he says. Right now, use of SGLT2 inhibitors for potential antiaging benefits is limited mostly to a growing community of so-called biohackers, who seek to optimize their health through experimentation with gadgets, behaviors and various medicines and supplements. Because most take it off-label—meaning, for a nonapproved use—the drugs typically aren't covered by insurance and can cost hundreds of dollars a month out of pocket. Dave Aiello, a Boston chiropractor who doesn't have diabetes, began experimenting with the drugs after learning about a promising study in mice. The 38-year-old wanted to get ahead of health problems but was disenchanted by what he saw as a reactive approach to disease in conventional medicine. 'I'm trying to see if I can just stay as healthy as possible for as long as possible," says Aiello, who has been taking an SGLT2 inhibitor called empagliflozin since 2022. He also takes the kidney-transplant drug rapamycin off-label and has previously taken the diabetes pill metformin—both of which have gained traction as potential longevity boosters, too. He was particularly impressed by research showing SGLT2 inhibitors can help the body manage blood sugar more efficiently, which in turn supports cardiometabolic health. He says he's encouraged by the results so far: Between 2022 and 2024, Aiello's hemoglobin A1C, a measure of average blood sugar, fell to 4.6% from 5.1%, his laboratory test results show. The drugs aren't free of potential side effects, including increased risk of urinary-tract infections, dehydration, and in rare cases, severe genital infections and a life-threatening condition called diabetic ketoacidosis. When Aiello first started taking empagliflozin, he felt dehydrated and experienced fatigue and brain fog. Those side effects have subsided since he decreased his dose and has made sure to take in more electrolytes. 'I'm a little more willing to take some risks that could potentially affect me in the short term if I do think that there might be a benefit," Aiello says. It isn't clear precisely how SGLT2 inhibitors might protect against the ravages of aging, but the research in mice offers clues. In 2020, a National Institute on Aging-funded study found that one SGLT2 inhibitor called canagliflozin extended the lives of male—but not female—mice by 14%. One theory is that the drugs help slow the aging process partly by blunting blood-sugar spikes. Scientists say that by driving insulin levels down, these drugs promote fat burning and create an anti-inflammatory effect that mimics calorie restriction, which studies suggest can slow the pace of aging. Still, many drugs that work in mice don't work in humans, says Richard A. Miller, who led the study and is director of the Glenn Center for Biology of Aging Research at the University of Michigan. His lab is now studying how the small molecules inside slow-aging mice change over time. If a drug in humans produces these same metabolomic shifts seen in slow-aging mice, he says, it would provide more confidence that it could slow aging in people. 'We still have a lot of work to do to prove that the drugs do the same thing in people," says Miller. 'The hint here is that it's actually slowing the aging rate." Alan Vuong, who works in sales in Austin, Texas, started taking the SGLT2 inhibitor dapagliflozin this year after hearing a podcast interview with Miller. The 34-year-old has a family history of Type 2 diabetes and wanted to lower his fasting insulin level, a measure of metabolic health, from normal to optimal. He spends about $150 a month on his longevity protocol, which includes a dozen drugs and supplements, and has seen his insulin levels drop since starting the medication. Other than having to use the bathroom in the middle of the night more often, a known side effect of the drugs, Vuong hasn't noticed other physical side effects. 'My end goal is to extend lifespan, but more importantly, healthspan," he says. 'I'm willing to take that gamble."

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