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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BioNTech announced it is partnering with Pfizer to begin testing a next-generation universal vaccine against coronaviruses, including SARS-CoV-2, the coronavirus that causes COVID-19.
Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover’s homologous booster against Omicron increases antibodies, and much more.
89bio reported positive topline results from ENTRIGUE Phase II trial of pegozafermin in patients with severe hypertriglyceridemia.
Axsome hosted an investor day event to provide an update on plans for Sunosi and other developmental assets, including MDD treatment AXS-05.
Icosavax posted positive topline interim data from its Phase I/Ib trial of IVX-121, its candidate virus-like particle vaccine against the respiratory syncytial virus in young and older adults.
Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
The Phase III study of Jazz Pharmaceuticals cannabis-derived MS Sativex failed to achieve the primary endpoint of an improvement in muscle tone in patients.
Roivant Sciences announced it has discontinued development of several assets following a pipeline reprioritization.
Ascletis has commenced its Phase II trial in China for its candidate drug ASC22 alongside anti-retroviral therapy for the functional cure and immune restoration of HIV-1 infection.
Boehringer and BiomX intend to use the discovery platform to identify biomarkers for a pathogenic bacterium thought to be associated with IBD.