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Exploiting Connections and Navigating Bumps Along the Brain-Gut Axis

 
• By Chris Morrison

The recent setback in SUI by Lilly's depression drug duloxetine may have implcations for a handful of biotech companies aiming to exploit their knowledge of the brain-gut axis to develop CNS drugs for IBS, OAB and other below-the-belt indications. Dynogen and Vela are two companies with promising products in the area.

The Food and Drug Administration's intimation to Eli Lilly & Co. in late January that the regulator wouldn't approve Lilly's serotonin and norepinephrine reuptake inhibitor (SNRI) duloxetine as a treatment for stress urinary incontinence (SUI) could be a setback for more than just Lilly and partner Boehringer Ingelheim GMBH . [See Deal]

The FDA move surprised observers, particularly considering the lack of existing pharmacotherapy for SUI and duloxetine's safety profile, which have...

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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.

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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.