Immunological
The FDA has approved the IL-23 inhibitor for Crohn's disease to add to its ulcerative colitis approval and put the drug in a position to compete with the likes of AbbVie's Skyrizi and Johnson & Johnson's Stelara.
The US biotech is paying $250m upfront to the Danish group in what is the second STAT6 deal secured in the past three weeks.
The company’s IgG antibody constructs have now failed in oncology and autoimmune disease, leaving it with few remaining strategic options.
The French biotech plans to file for EMA approval in graft-versus-host disease in mid-2025 while starting a US Phase III trial, which the CEO said in an interview is contingent on financing.
The company reported positive Phase II data from the BEACON trial testing the c-Kit inhibitor in chronic spontaneous urticaria and said it is planning a Phase IIb/III program.
With new Phase I/II data for its anti-IGF-1 agent lonigutamab, Acelyrin will move into Phase III in thyroid eye disease. But how competitive it will be versus Tepezza or Viridian’s Phase III candidate is uncertain.
While quieter than some recent years, 2024 did produce several clinical trial readouts destined to have an impact on their respective markets. Here, in roughly chronological order, Scrip takes a look at the 10 clinical stories that got readers clicking the most over the past 12 months.
The biopharma sector has once again experienced highs and lows this year. With just a week left, and in no particular order, Scrip takes a look at five of the biggest stories of 2024.
CytoCares’ CEO shares plans for CC312, a potentially first-in-class trispecific antibody for autoimmune disorders it sees as differentiated from global rivals.
Certa and OccuRx both came out of Fibrotech and are now joining forces to advance asengeprast as a potential therapy for scleroderma and focal segmental glomerulosclerosis.
Looking to compete with Amgen’s Tepezza, veligrotug has now met efficacy and safety endpoints in active and chronic patients, while offering less burdensome dosing.
The French group says it can only fund operations in the first quarter of 2025 but having secured “a clear and reasonable pathway towards an accelerated approval” after talks with the US Food and Drug Administration for its Viaskin Peanut patch in toddlers, the future is looking much brighter.
The immunology company has used business development to bring in atopic dermatitis bispecific antibodies. J&J VP-immunodermatology disease area leader Liza O’Dowd talked to Scrip about the developments.
Topical, oral and biologic drugs have made a difference for patients with atopic dermatitis, but full control remains elusive for many, with the heterogeneous condition, leaving open a door for new medications.
Deal Snapshot: December is just over a week old but the UK giant has packed a lot in, signing collaborations with likes of Duality Biologics (cancer) and Muna Therapeutics (neurodegeneration). Now it is targeting fibrotic diseases and osteoarthritis after inking a deal with Relation Therapeutics.
The Dutch group has assembled an impressive syndicate which is betting that the first-in-class monoclonal antibody CIT-013 could be a transformative treatment for rheumatoid arthritis and hidradenitis suppurativa.
The US healthcare giant says that icotrokinra could provide an “industry-leading combination of significant skin clearance with demonstrated tolerability in a once-daily pill" after succeeding in late-stage trials.
Incyte is looking to expand in dermatology, but two products at the center of its Escient buyout earlier this year have run into some trouble.
The company said it does not see a development path for zelnecirnon based on feedback from the US FDA. It halted two Phase II trials in asthma and atopic dermatitis earlier this year.
Uptake in immunology, gastrointestinal and dermatology indications have enabled Skyrizi to post 51% year-over-year growth, and overtake sales for biosimilar-challenged stalwart Humira.