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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PTC Therapeutics reported Q4 and full-year 2022 results Tuesday ahead of a pivotal 2023 featuring three late-stage readouts in registration-directed trials.
After overcoming a clinical hold, Astellas presented preliminary safety and efficacy data from the Phase I/II FORTIS trial of AT845 in late-onset Pompe disease at the 19th Annual WORLDSymposium 2023.
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.
Actinium Pharmaceuticals’ Iomab-B met the primary endpoint in the Phase III SIERRA trial, demonstrating durable Complete Remission at six months.
On Friday, the FDA approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) as the first treatment for geographic atrophy (GA), a leading cause of blindness.
Takeda’s vedolizumab met its primary endpoint in the Phase III GRAPHITE study, significantly improving event-free survival in patients with acute graft-versus-host disease.
Hemab Therapeutics announced the closing of an oversubscribed Series B round to bring new treatment options for lesser-known bleeding disorders.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Moderna announced mixed interim results Thursday from a Phase III trial of mRNA seasonal flu vaccine candidate, mRNA-1010.