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.
FEATURED STORIES
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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In advanced non-small cell lung cancer, Summit Therapeutics’ ivonescimab appears to be 49% more effective at reducing the risk of disease progression or death versus Merck’s Keytruda in a late-stage study. However, analysts contend the caveat is that the trial was conducted in an entirely Chinese patient population.
Follow-up data from the MARIPOSA study show a favorable overall survival trend versus Tagrisso in EGFR-mutated advanced non-small cell lung cancer. The findings come just weeks after the Rybrevant-Lazcluze combination was approved for the first-line treatment.
Using a computational biomarker, the companies say they can identify which patients would derive significant clinical benefit from their experimental antibody-drug conjugate. AstraZeneca and Roche are co-developing and commercializing a companion diagnostic for the biomarker.
Bispecific antibodies and anti-TIGIT therapies both appear to be writing comeback stories as cancer experts head to Barcelona for the 2024 European Society for Medical Oncology Congress. Radioligand therapies and synthetic lethality assets are also attracting attention.
The next generation of Alzheimer’s therapeutics is moving away from amyloid plaques and tau tangles, offering multiple approaches to slow cognitive decline.
Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month—Sanofi and Regeneron’s blockbuster Dupixent.
BioMarin executives sought to calm an anxious investor base Wednesday with a public address and pledge to achieve a nearly 50% bump in annual revenue by 2027. But analysts were left wanting.
Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.