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Neuralstem Plans Deep Dive Into Failed Phase II Major Depression Trial

 
• By Emily Hayes

Failure of NSI-189 in major depression study sends stock price down about 50% and next steps for development are unclear.

Neuralstem Inc. will be looking for new leads from a robust analysis of a failed Phase II study of its small molecule therapy NSI-189 in major depressive disorder (MDD) to guide next steps for the candidate.

According to the company, NSI-189 increases neurogenesis and stimulates volume in stem cells in the hippocampus, though its exact mechanism...

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More from Neurological

Atai Gives Up On Recognify’s Schizophrenia Drug After Phase IIb Miss

 
• By Joseph Haas

Set to merge with Beckley Psytech, Atai will focus on psychedelic candidates for treatment-resistant depression while Recognify will analyze Phase IIb data for possible next steps.

Roche Unveils Alzheimer’s Phase III Plan And Preclinical Study

 
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The trontinemab Phase III study is due to get underway this year, with Roche confident its brainshuttle technology will help it surpass approved rivals.

Gilead’s Yeytuo, Lilly’s Kisunla Headline CHMP Positive Opinions

 
• By Alaric DeArment

Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 
• By Alaric DeArment

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

More from Therapy Areas

GSK’s Blenrep US Setback Could Go From Bad To Worse

 
• By Sushmita Panda

With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.