Clinical Trials

EADV: Leo Makes A Big Leap With Eczema Drug Temtokibart Set For Phase III

 
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CSO Jacob Thyssen tells Scrip that the monoclonal antibody which blocks the IL-22RA1 receptor subunit is a very safe and effective option to treat the chronic inflammatory skin disease.

Incyte’s Povorcitinib Wins Stack Up, Will It Be Enough To Hedge Jakafi Loss?

 
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With patent expiry for its blockbuster blood cancer drug Jakafi on the horizon, Incyte will need to translate these povorcitinib wins from clinic to market.

Regeneron’s Garetosmab May Become Second Drug For Rare Bone Disease FOP

 

The company announced positive Phase III data for the drug in fibrodysplasia ossificans progressiva, as well as Phase II combination data among patients with obesity.

Roivant Sets The Stage For Commercial Return With Brepocitinib Data

 

Positive Phase III data positions Roivant to launch the oral TYK2/JAK1 inhibitor for dermatomyositis, with an NDA filing planned in early 2026.


AstraZeneca’s Fasenra RESOLUTE Failure Highlights The Limits Of Biologics In COPD

 

AstraZeneca’s IL-5 blocker has again missed in COPD, adding to a number of disappointments for biologics in this disease. Complex biology and overlapping inflammatory pathways seem to be at the heart of the problem.

Lilly’s Orforglipron Bests Novo Rival In First Oral Head-To-Head Study

 

The company’s cardiometabolic leader Ken Custer discusses the topline ACHIEVE-3 results in diabetes and just-published full results of ATTAIN-1 in obesity of orforglipron, with a pledge to maximize access to the oral GLP-1 therapy worldwide, once approved.

EADV: Sanofi Smiles Again As Brivekimig Blooms In HS Study

 
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The dual TNFα/OX40L drug comfortably beat placebo in reducing symptoms of hidradenitis suppurativa but no news on Phase III plans yet.

Areteia Looks To Take On Biologics In Eosinophilic Asthma With Dexpramipexole

 

The company announced positive topline Phase III results for the first of a series of Phase III studies of the drug in inadequately controlled disease.


Skepticism Greets aTyr’s Plans To Take Efzofitimod To Regulators

 

The company reported that the Phase III EFZO-FIT trial in pulmonary sarcoidosis did not meet the primary endpoint, but showed improvement on a secondary endpoint.

Eli Lilly Thinks Twice About Lab Investment, Adding To UK Gloom

 

A pause to Lilly’s plans for a UK biotech incubator reflect escalating tensions between pharma and the British government.

Pipeline Watch: Seven Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Biokin/BMS, Genfleet/Verastem’s Drug Candidates Impress At WCLC

 

With data generated from China-only trials and consistency issues lingering, Chinese drug makers presented impressive results from early-stage studies of their assets at the World Conference on Lung Cancer annual conference.


Revolution’s Daraxonrasib Data Bolster Phase III Case Amid RAS Cancer Push

 

The company announced positive monotherapy and chemotherapy-combination data for the RAS(ON) inhibitor in first-line pancreatic ductal adenocarcinoma.

Eyes On Icotrokinra As J&J Submits Oral Psoriasis Therapy

 
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The EMA is reviewing the IL-23-targeting oral peptide which the company claims will transform the plaque psoriasis treatment paradigm.

Indigenization, AI Drive ICMR, Gennova, Zydus Vaccine Efforts In India

 
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Indian firms are upping indigenization, exploring AI application and expanding use of technology platforms like self-amplifying mRNA to develop vaccines against age-agnostic diseases like malaria, dengue, flu and Nipah encephalitis

Capsida Is Latest To Have Patient Fatality In Gene Therapy Trial

 

The privately owned biotech said it would pause its Phase I/II study of CAP-002 in STXBP1-related disorders after the first patient in the study died.


For PMV Pharma, Ovarian Cancer Is First Big Stop On Rezatapopt’s Regulatory Journey

 

PMV announced positive data from its Phase II trial in multiple TP53 Y220C-mutant solid tumors, with the second-line ovarian cancer opportunity worth up to $630m.

BioNTech/BMS Novel Bispecific Global Study Consistent With China-Only Results

 

Interim Phase II data showed a 76% response rate with pumitamig plus chemo in first-line extensive-stage small-cell lung cancer, largely in line with data from an earlier China-only trial. Analysts say more mature outcomes data will be key as a Phase III trial advances.

Can You Keep The Cat and The Relationship? Regeneron Thinks So

 
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Regeneron’s CEO has highlighted the large market potential for effective new anti-allergy treatments after the company reported positive data from a pair of allergen-blocking antibodies.

Daiichi Sankyo/Merck’s I-Dxd Tipped For Fast Track After Lung Cancer Results

 

The companies’ multi-billion dollar collaboration on antibody-drug conjugates could be starting to pay off, with a potential first-in-class filing for ifinatamab deruxtecan (I-Dxd) based on promising Phase II data just presented at WCLC.