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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AstraZeneca released data Wednesday morning from two studies in breast cancer: the Phase III CAPItello-291 trial studying capivasertib and the Phase II SERENA-2 trial studying camizestrant.
One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
The FDA has greenlit the use of Johnson & Johnson’s Tecvayli in heavily pretreated adult patients with relapsed or refractory multiple myeloma.
GSK terminated its cell therapy pact with Lyell Immunopharma. It’s opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.
AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.
Novartis’ positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.
Taysha Gene Therapies has entered into a strategic equity investment and licensing deal with Astellas. The latter stands to gain access to Taysha’s gene therapy development programs for Rett syndrome and GAN.
Data from two Phase I trials indicate Gritstone Bio’s samRNA vaccine can safely induce a strong and durable immune response against COVID-19.
In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.