Drug Development

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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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When Roche announced that gantenerumab failed to meet the primary endpoint in two Phase III studies, several of its competitors saw their stocks rise - including Biogen and Eisai.
RSV, influenza, COVID-19 and monkeypox have dominated vaccine discussions this year, but vaccines are also being developed for a host of other infectious diseases.
Neoleukin Therapeutics plans to slash its workforce by about 40% and drop NL-201, a de novo IL-2/IL-15 agonist currently in Phase I, according to its third-quarter report.
Beam Therapeutics has enrolled the first patient in a Phase I/II trial studying a gene therapy leveraging base editing in adults with severe sickle cell disease.
Surrozen announced it paused its Phase I study in Crohn’s disease and ulcerative colitis as several healthy participants showed increased levels of liver enzymes.
Stoke Therapeutics is gearing up for a pivotal trial of its lead program for a rare genetic epilepsy disease and announced positive results from its Phase I/IIa study in children with Dravet syndrome.
Topline results from the Phase III SUMMIT trial showed Satsuma Pharmaceuticals’ migraine candidate STS101 did not meet its primary efficacy endpoint.
MBX Biosciences secured $115 million in Series B financing to advance its pipeline of Precision Endocrine Peptides for endocrine disorders.
Roche announced its investigational antibody gantenerumab failed to meet the primary endpoints in GRADUATE I and II - two Phase III studies in Alzheimer’s disease.
Early data from a combination of Cue Biopharma’s CUE-101 and Keytruda shows the treatment is effective in patients with recurrent/metastatic HPV16+ head and neck cancer.