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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Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.
The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval.
The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens.
Lilly investigators said they hoped to differentiate their Phase I candidate from the competitive KRAS space by making it the first to gain approval as a first-line treatment.
The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.