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.
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.
UBS has launched coverage of Arcellx with a Buy rating and a $100 price target, signaling growing Wall Street confidence in a biotech sector recovery and spotlighting the company's promising CAR-T therapy for multiple myeloma.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
Ovid Therapeutics (NASDAQ: OVID) has garnered analyst optimism following positive Phase 1 trial results for its novel neurological drug candidate and a recent 'Outperform' initiation. The biotech firm is now shifting focus to a more potent oral therapy, with key regulatory milestones ahead.
Piper Sandler raises its price target for Century Therapeutics (IPSC), highlighting the biotech firm's robust financial position extending into 2029 and an upcoming Investigational New Drug application for its lead cell therapy candidate, CNTY-813.
Shares of Perspective Therapeutics (CATX) have rallied sharply following encouraging interim results from its lead cancer therapy trial and a strategic business update. While the data fuels optimism, a deep dive into the numbers reveals a stark disconnect between its current market price and analyst targets, highlighting both opportunity and significant risk.
RBC Capital has reaffirmed its confidence in Ascendis Pharma, raising its price target following the company's ambitious 2026 strategic goals, which hinge on sustained momentum for its lead therapy and significant long-term revenue targets.
