Chris Gasink’s Post

BioCity Biopharma's SC0062 has achieved a significant milestone by successfully meeting the primary endpoint of proteinuria reduction in the 2-SUCCEED trial. This randomized, double-blind, placebo-controlled, phase 2 clinical trial underscores the efficacy and safety of SC0062 in chronic kidney disease (CKD) patients, particularly those with IgA nephropathy. By selectively targeting the endothelin receptor type A, SC0062 demonstrates promise in mitigating proteinuria, a critical marker of kidney damage and CKD progression. BioCity Biopharma is steadfast in advancing SC0062 development and aims to present detailed findings at upcoming medical conferences and publish the results in a peer-reviewed journal. Read the full article at https://lnkd.in/eu46yETR

𝙁𝘿𝘼 𝙂𝙧𝙖𝙣𝙩𝙨 𝙍𝙈𝘼𝙏 𝘿𝙚𝙨𝙞𝙜𝙣𝙖𝙩𝙞𝙤𝙣 𝙩𝙤 𝙆𝙮𝙫𝙚𝙧𝙣𝙖 𝙏𝙝𝙚𝙧𝙖𝙥𝙚𝙪𝙩𝙞𝙘𝙨’ 𝘾𝘼𝙍 𝙏-𝘾𝙚𝙡𝙡 𝙏𝙝𝙚𝙧𝙖𝙥𝙮 𝙛𝙤𝙧 𝙎𝙩𝙞𝙛𝙛-𝙋𝙚𝙧𝙨𝙤𝙣 𝙎𝙮𝙣𝙙𝙧𝙤𝙢𝙚 The US FDA has granted RMAT designation for Kyverna Therapeutics’ CAR T-cell product candidate, KYV-101, for treating refractory stiff-person syndrome (SPS) 🎉. SPS is a rare, debilitating neurological autoimmune disorder characterized by muscle stiffness and spasms. KYV-101 is an autologous, fully human CD19 CAR T-cell therapy designed to address B cell-driven autoimmune diseases 💪. This innovative CAR technology, developed by the NIH, has shown promise in a Phase I oncology trial with results published in Nature Medicine 📚. KYV-101 is currently undergoing clinical evaluation in the US and Germany through sponsored Phase I/II and Phase II trials. Kyverna Therapeutics is hiring for a DIrector, Medical Affairs (Emeryville, CA) https://lnkd.in/gs8NDs-u #CARTcellTherapy #AutoimmuneDisease #FDA #RMAT #ClinicalTrials #Innovation #Biotech

Muzamil Saleem, PhD writes a fascinating and informative piece on NASH and the challenges in studying, testing and treating this "silent killer." Muz, thanks for this. I am lucky to get to work with scientists like you at ProEd Regulatory ! #liverdisease #nafld #nash #biomarkers #drugdevelopment #clinicaltrials #hepatology #fda #healthcare #regulatoryaffairs #workshop #ai

Check out my new blog about the FDA's recent workshop to address knowledge gaps in noninvasive tests related to nonalcoholic steatohepatitis (NASH). 

In this blog, we discuss the FDA's recent effort to address knowledge gaps in noninvasive tests related to nonalcoholic steatohepatitis (NASH). We examine the implications for screening, diagnosis, and monitoring treatment response in the context of both drug development and advancing the NASH clinic. #NASH #FDA #RegulatoryWatch https://lnkd.in/emUqv2bc

𝐓𝐡𝐞 𝐅𝐃𝐀 𝐇𝐚𝐬 𝐂𝐥𝐞𝐚𝐫𝐞𝐝 𝐭𝐡𝐞 𝐅𝐢𝐫𝐬𝐭 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐚 𝐏𝐫𝐢𝐦𝐞 𝐄𝐝𝐢𝐭𝐨𝐫 Prime Medicine, Inc. Medicine announced this week that the FDA has cleared its investigational new drug application for PM359 for the treatment of chronic granulomatous disease. PM359 will be the first prime-editing therapeutic candidate to enter the clinic. Read more at CRISPR Medicine News 👇🏻 https://lnkd.in/e-nEnaGY #crisprmedicinenews #crisprmedicine #crispr #primeediting #immunedeficiency #clinicalnews #geneediting

Prime editing is heading for the clinic!! The FDA has cleared Prime Medicine's application to begin a clinical trial of PM359 in chronic granulomatous disease. Congrats to all involved in reaching this milestone, Prime Medicine, Inc. #crisprmedicinenews #crisrpmedicine #primeediting #crisprtrial #clinicalnews

This is another piece of very exciting news!! Another green light for a #crispr clinical trial. And not only that, but also the first Prime Editor! #crisprcas9 #crisprtherapeutics #genetherapy #geneediting #genomeediting #celltherapy #rnatherapeutics

Are you satisfied with your current dermatomyositis treatment? If you are still experiencing symptoms with your dermatomyositis, you may be interested in learning about a clinical study sponsored by Proviant Therapeutics The Valor Study is evaluating an investigational medicine called brepocitinib to see if it may improve symptoms of dermatomyositis in adults 18-75 years old Your participation of the study may last up to 116 weeks, and you will have a visit to the study site approximately every 4 to 12 weeks. Once you complete the Blinded Treatment Period, you may have the option to continue in an Open-label Extension Period. If you are eligible and decide to participate, you will: * Receive study drug at no cost * Be closely monitored by the study doctor * Join others in helping to advance research for dermatomyositis Participation is voluntary, and if you decide to join, you can choose to stop at any time. To learn more about the Valor Study, go to; www.VALORStudy.com OR click the link in our bio to go directly to the study website #dermatomyositis #ValorStudy #ClinicalTrials #ClinicalTrial #DermatomyositisPatient #myositis #MyositisLife #MyositisClinicalTrial #ProviantTherapeutics

𝙅𝙤𝙝𝙣𝙨𝙤𝙣 & 𝙅𝙤𝙝𝙣𝙨𝙤𝙣 𝙧𝙚𝙥𝙤𝙧𝙩𝙨 𝙥𝙤𝙨𝙞𝙩𝙞𝙫𝙚 𝙋𝙝𝙖𝙨𝙚 3 𝙧𝙚𝙨𝙪𝙡𝙩𝙨 𝙞𝙣 𝙈𝙮𝙖𝙨𝙩𝙝𝙚𝙣𝙞𝙖 𝙂𝙧𝙖𝙫𝙞𝙨 💊 Johnson & Johnson announced significant positive results from the Vivacity-MG3 𝗽𝗵𝗮𝘀𝗲 𝟯 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 of nipocalimab in patients with generalized myasthenia gravis (gMG). The study enrolled 199 patients over 24 weeks, showing a substantial improvement in daily living activities and muscle function. 📈 Positive trial results can lead to increased investor confidence and potentially drive up J&J's stock value. With the potential regulatory approval of nipocalimab, J&J could see a boost in its immunology segment revenues, further strengthening its financial position in the biopharma market. Potential $𝟲.𝟱 𝗯𝗶𝗹𝗹𝗶𝗼𝗻 𝗽𝗿𝗼𝘀𝗽𝗲𝗰𝘁. 💰 The 𝗴𝗠𝗚 𝗺𝗮𝗿𝗸𝗲𝘁 is projected to grow significantly, with a rising number of cases and demand for effective treatments. Successful commercialization of nipocalimab could capture a substantial market share, providing a new revenue stream for J&J. Despite these promising results, how will Johnson & Johnson navigate the potential regulatory and market access challenges to ensure nipocalimab reaches the patients who need it most? #headcountag #JNJ #clinicaltrial #phase3 #investment https://lnkd.in/ddWvp7tQ