Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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BioMed X and Sanofi have inked an R&D collaboration to use digital data and artificial intelligence to predict the efficacy of first-in-class drug candidates using virtual patient populations.
The FDA greenlit AstraZeneca’s tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma.
Alpine Immune Sciences has voluntarily terminated enrollment in two clinical trials of its immuno-oncology asset, davoceticept, after a second patient death.
Top-line data from Tricida’s VALOR-CKD trial showed veverimer failed to meet its primary endpoint and does not slow progression in patients with metabolic acidosis and CKD.
In a Phase III trial comparing Novartis’ experimental iptacopan against AstraZeneca’s Soliris and Ultomiris in paroxysmal nocturnal hemoglobinuria, iptacopan demonstrated superiority.
New data from Scholar Rock’s Phase II TOPAZ trial showed its investigational antibody apitegromab improves quality of life in types 2 and 3 spinal muscular atrophy patients.
Shares of Immunic stock have plunged more than 70% in premarket trading after an early peek at its Phase Ib psoriasis drug candidate has so far failed to distinguish itself from placebo.
Roche and Austria-based Hookipa Pharma tied up a licensing and research and development collaboration valued at more than $950 million focused on KRAS-mutated cancers.
After the Data Monitoring Committee reviewed the case based on protocol modifications implemented earlier this year, it was determined that enrollment in the trial and dosing may continue.
BMS’s blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate -76K trial for a particularly intractable form of melanoma.