Cogent Biosciences secures a key FDA Breakthrough Therapy Designation for its bezuclastinib-sunitinib combination in advanced GIST, following promising Phase 3 data that showed a halving of disease progression risk.
Cogent Biosciences secures FDA Breakthrough Therapy Designation and enters the Real-Time Oncology Review program for its lead drug candidate bezuclastinib in gastrointestinal stromal tumors (GIST), marking significant regulatory momentum for the biotech firm.
Following the FDA's decision to remove the clinical hold on Intellia's Nex-Z hATTR-PN trial, analysts at Baird and H.C. Wainwright have significantly raised their price targets for the CRISPR gene-editing pioneer, citing reduced regulatory risk and a clearer path forward.
Glaukos Corporation's iDose TR glaucoma therapy receives a key FDA labeling update, permitting repeat administration. While the news bolsters the company's growth narrative, analysts are divided on whether its current stock price already reflects future potential amid rich valuation metrics.
The FDA's approval of a repeat treatment protocol for Glaukos's iDose TR implant transforms it from a one-time procedure into a potential chronic therapy platform, reshaping its commercial narrative and investor calculus in the competitive glaucoma market.
Glaukos Corporation secures a significant FDA nod allowing repeated administration of its sustained-release iDose TR implant, broadening treatment options for patients with glaucoma and potentially reshaping long-term care paradigms.
Exelixis has filed its next-generation therapy zanzalintinib with U.S. regulators for metastatic colorectal cancer, marking a significant step in its clinical development and potentially enhancing its competitive position in the targeted oncology space.
The FDA's Priority Review for Vyvgart's label expansion in myasthenia gravis accelerates Argenx's growth strategy, while investors weigh the company's broader pipeline against its current valuation.
The FDA clearance of Spectrum Dynamics' Veritas.AI platform marks a significant step forward for nuclear imaging, promising to cut scan times in half and enhance image clarity for critical applications like cancer theranostics.
Takeda Pharmaceutical raises its FY2025 revenue and profit guidance following resilient nine-month results and announces U.S. availability of a new ready-to-use immunoglobulin therapy for primary immunodeficiency, fueling discussions on its growth strategy amid high debt and margin pressures.
The FDA has cleared Intuitive Surgical's latest robotic system for use in certain heart surgeries, marking a strategic expansion into one of healthcare's largest and most complex service lines and potentially reshaping hospital capital planning for robotics.
New long-term results from the pivotal EMBARK trial indicate ELEVIDYS, Sarepta's gene therapy, continues to alter the disease trajectory for boys with Duchenne muscular dystrophy, with no new safety concerns emerging over three years.
Shares of Corcept Therapeutics plunged 16% after a corrected FDA letter disclosed the agency had repeatedly cautioned the company against filing its application for a Cushing's syndrome drug, which was later rejected over efficacy and safety concerns.
Eli Lilly bolsters its long-term growth strategy through two new R&D partnerships and a key regulatory milestone for an ovarian cancer drug, signaling a strategic push beyond its blockbuster diabetes and obesity treatments.
Wells Fargo boosts its price target for Taysha Gene Therapies (TSHA), citing strong progress in its pivotal Rett syndrome gene therapy program. The company has dosed the first patient in a key trial phase and received FDA alignment on its regulatory pathway.
Quince Therapeutics' lead candidate, eDSP, has failed to meet primary and secondary endpoints in its pivotal Phase III NEAT trial for the rare neurological disorder Ataxia-Telangiectasia (A-T), triggering a catastrophic drop in the company's share price.
Novo Nordisk charts a bold new course, launching a pivotal oral obesity drug while restructuring its workforce and deepening its investment in next-generation cell therapies for metabolic diseases.
At its Analyst Day, Korro Bio detailed its lead candidate KRRO-121, an RNA-editing therapeutic designed to tackle hyperammonemia in urea cycle disorders and hepatic encephalopathy by stabilizing a key liver enzyme, positioning it as a potential paradigm shift from current burdensome treatments.
Japan has successfully retrieved rare-earth-rich sediment from the deep Pacific seabed in a world-first test, marking a significant step in its national strategy to diversify critical mineral supplies and reduce dependence on China.
The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.
