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Argos Not Stopping Cancer Vaccine Study Despite Futility

 
• By Joseph Haas

The biotech suggests that ADAPT trial design was not ideally structured to show the longer-term benefit that might result from its autologous immunotherapy. Argos plans to discuss its plan with FDA in May, despite analyst skepticism.

Cancer cells

Argos Therapeutics Inc. wants to finish out the Phase III ADAPT trial of its personalized immunotherapy for metastatic renal cell carcinoma (mRCC) despite an interim data review that indicates lower median overall survival compared to control and a recommendation by the independent data monitoring committee that the study be terminated.

In an April 18 investor call to review the data and its rationale for continuing the trial, North Carolina-based Argos...

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• By Sushmita Panda

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 
• By Anju Ghangurde

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 
• By Sushmita Panda

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

 
• By Joseph Haas

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.

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Europe’s Drugmakers Lament EU Pharma Package

 
• By Kevin Grogan

EFPIA says reforms make the continent less attractive for innovative firms.

ASCO: Carvykti Data Raise Possibility Of Myeloma Cure

 
• By Alaric DeArment

J&J presented data at the American Society of Clinical Oncology meeting showing more than five-year disease- and therapy-free survival, but a myeloma working group will need to define what makes a cure.

Vigil’s Iluzanebart Disappoints In Rare Neurodegenerative Disease

 
• By Jessica Merrill

The Phase II TREM2 agonist is not part of Sanofi’s planned acquisition.