Phase 2
Argenx shares have fallen more than 13% after the surprise futility finding, which overshadowed a mid-stage celiac disease win for a separate asset acquired in the company’s $2.2 billion Forte Biosciences buy.
For the second time in a week, Zealand Pharma’s weight loss pipeline has delivered mixed results, this time in a Phase 2 trial for the Roche-partnered asset petrelintide.
All signs continue to point forward for Biogen’s initial foray into lupus, as litifilimab elicited clear or almost clear skin within one year in patients with cutaneous lupus in a mid-stage study. Data from two Phase 3 studies of systemic lupus are expected by the end of the year.
Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.
Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’s Humira and UCB’s Bimzelx.
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.
Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up.
While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia.
Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.
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