Drug Development
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
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At the European Society for Medical Oncology meeting this weekend, Merck will showcase three late-stage trials of its Kelun-Biotech–partnered TROP2-directed antibody sac-TMT that VP of Chemistry Alan Northrup says gets the payload release “just right.”
Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
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Troriluzole, in development for spinocerebellar ataxia, was rejected nearly a year ago when the FDA took issue with the design of Biohaven’s registrational study. The agency has now agreed to review a new application and render a decision in the first quarter of 2027.
The sector’s IPO tally has surpassed each of the past four years, with four October debuts adding momentum—but activity still remains well below the COVID-19 boom that saw nearly 100 public debuts in 2021.
The approval of Hibsago has created a new market for a handful of biopharmas, including Gilead, Arrowhead, and Vir, to fill in.
In this episode of Denatured, you’ll hear from Bruce Culleton, CEO at ProKidney and Demetri Maxim, CEO at Nephrogen. We discuss why kidney disease has long been a hard target for cell and gene therapies, and what new delivery strategies, therapeutic approaches and regulatory clarity mean for commercially viable products.
Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.”
China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck, and Summit Therapeutics.
Posthoc analyses in women divided by menopausal status show how Novo’s next-generation GLP-1 drug affects key cohorts of patients.
Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipolar mania.
Gilead’s emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company’s push beyond its HIV portfolio.
AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster can be outdone.