Immunological

Scrip Asks... What Does 2025 Hold For Biopharma? Part 6: Therapeutic Area Advances

 

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

Dupixent Set To Dominate Bullous Pemphigoid Space

 

Argenx has discontinued Vyvgart for the rare skin disease as other potential candidates linger in the very early stages of development.

Alumis To Merge With Acelyrin, But Pause Lonigutamab Program

 

Alumis said it will pause the planned Phase III program for Acelyrin’s lead drug and assess the value of the candidate, which produced underwhelming Phase II results in January.

10 Clinical Trials To Look Out For In 2025

 

Scrip surveys some of the more interesting Phase III clinical trial readouts expected this year.


Roche Expands TL1A Development In A Catalyst-Rich Year

 

The company ended the year with financial momentum and will initiate clinical trials for its anti-TL1A in atopic dermatitis and MASH on top of late-stage studies ongoing in IBD.

Sanofi Happy To Spend To Hit Immunology Top Spot

CEO Paul Hudson has declared that “immunology is effectively our obesity” and the French firm is looking to use its position of strength in the space and its healthy cash pile to bring in early-stage assets.

Switzerland’s AB2 Bio Bags Nippon Shinyaku As Late-Stage IL-18 Inhibitor Partner

 
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CEO Djordje Filipovic tells Scrip that after talks with "multiple other potential partners,” the firm chose the Japanese group for its expertise and marketing capabilities in rare diseases” to be the licensing partner for tadekinig alfa in the US.

R&D In The IRA Era: Takeda Opts Not To Develop Zasocitinib For Lupus

 

The TYK2 inhibitor is in Phase III development for plaque psoriasis and psoriatic arthritis but the company said it will not pursue late-stage studies in lupus, partly due to the Inflation Reduction Act.


Crohn’s Gets More Competitive As Lilly Lands Second Omvoh Okay

 
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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.

Gilead and Leo Pact Adds Fuel To Hot STAT6 Inflammation Space

 
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The US biotech is paying $250m upfront to the Danish group in what is the second STAT6 deal secured in the past three weeks.

Crisis Deepens At IGM Biosciences As Autoimmune Gambit Fails

 

The company’s IgG antibody constructs have now failed in oncology and autoimmune disease, leaving it with few remaining strategic options.

MaaT Prepares For EMA Filing, US Expansion After Positive GVHD Readout

 

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.


Jasper’s Briquilimab Stands Up To Competition, But Investors Bail

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.

Acelyrin To Take Tepezza Competitor Into Phase III In TED

 
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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.

10 Clinical Trials Of 2024 – Hits, Misses And Some In Between

 

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 Top Five Pharma Stories Of 2024

 
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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.


TCE Specialist CytoCares Makes Inroads Into Autoimmune Space

 

CytoCares’ CEO shares plans for CC312, a potentially first-in-class trispecific antibody for autoimmune disorders it sees as differentiated from global rivals.

Australian Fibrosis Pioneers Merge Ahead Of Financing

 
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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.

Viridian Continues Building Case For Veligrotug In TED

 
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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.

Cash-Strapped DBV Gets FDA Boost For Peanut Allergy Patch

 
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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.