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.
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.
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.
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.
H.C. Wainwright maintains a Buy rating on Lexeo Therapeutics but slashes its price target, citing persistent market doubts over the company's PKP2 cardiomyopathy program despite encouraging early clinical results.
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.
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.
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.
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.
Pharmaceutical giant Eli Lilly announces a major $3.5 billion manufacturing expansion for its weight-loss drugs and enters two strategic research collaborations in gene editing and immunology, signaling aggressive growth plans amid a recent stock valuation dip.
Iran has summoned the ambassadors of all European Union member states in Tehran in a sharp diplomatic protest against the bloc's move to formally designate the Islamic Revolutionary Guard Corps (IRGC) as a terrorist organization.
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.
Sanofi announces promising late-stage results for its immunology candidate amlitelimab and expands into genetic therapies via an investment in Sensorion, signaling a strategic push into high-value therapeutic areas.
ResMed Inc. reports an 11% revenue surge for its second fiscal quarter, driven by robust mask sales and strategic acquisitions, while navigating competitive pressures and capitalizing on emerging healthcare trends.
While Legend Biotech's CAR-T therapy Carvykti missed Q4 sales estimates, prompting mixed analyst reactions, some firms emphasize its curative potential and view the stock's recent decline as a strategic entry point for investors.
Sanofi reports a pivotal Phase 3 win for its investigational therapy venglustat in a rare neurological disorder, alongside positive EU regulatory news for Rezurock and progress for amlitelimab, signaling a strategic shift toward high-value specialty medicines.
Iranian officials confirm active review of diplomatic channels with Washington, signaling potential de-escalation as military posturing continues in the Gulf region.
Japan has successfully retrieved sediment containing rare earth minerals from a depth of 6,000 meters in the Pacific Ocean, marking a world-first achievement in deep-sea resource exploration. The mission, part of a strategic push to reduce reliance on Chinese supplies, could reshape global supply chains for critical technology components.
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.
