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.
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.
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.
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.
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.
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.
Barclays initiates coverage of 4D Molecular Therapeutics with an Overweight rating and a $33 price target, citing a favorable industry backdrop with potential M&A tailwinds and shifting focus away from drug pricing pressures. The gene therapy developer also outlined key clinical milestones expected through 2026.
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.
The Apis Flagship Fund reported robust quarterly and annual gains for 2025, significantly beating global benchmarks. While highlighting its performance drivers, the fund's investor letter also discussed its position on gene therapy firm uniQure (QURE).
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.
