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Galectin Offers Subgroup Approach For Struggling NASH Candidate

 
• By Joseph Haas

Having failed to meet its primary endpoint in consecutive Phase II studies, Galectin hopes to move GR-MD-02 forward in NASH in patients with cirrhosis who have not developed esophageal varices.

scientists doing lab research on digital screen

Galectin Therapeutics Inc. thinks subgroup analysis of its failed Phase IIb study in non-alcoholic steatohepatitis (NASH) highlights a way forward for its complex carbohydrate drug GR-MD-02, but investors don't seem to agree.

The Norcross, Ga., biotech reported Dec. 5 that GR-MD-02, targeting the galectin-3 protein which plays a role in fatty liver...

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Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
• 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.

More from R&D

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.