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Nippon Shinyaku Co., Ltd.

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Latest From Nippon Shinyaku Co., Ltd.

Autobahn Speeds Lead Drug Into Phase II With $100m In Fresh Cash

Autobahn raised $100m in series C venture capital to take its oral, brain-penetrant thyromimetic ABX-002 into Phase II studies in major depressive disorder and bipolar disorder depression.

Financing Neurology

All Over For Asarina With No Partner Found For Tourette's Drug

Sepranolone may have progressed positively through a Phase IIa trial but its potential to reduce tics has failed to tempt any of the 20 or so potential partners that the Swedish biotech spoke to about a licensing deal.

Neurology Business Strategies

Lead Daiichi/Merck ADC Collab HER3-DXd Hit With CRL

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.

Complete Response Letters United States

Déjà Vu: CBER Director’s Intervention Saves Sarepta’s Elevidys Again

Failure of the EMBARK confirmatory trial convinced US FDA reviewers the Duchenne muscular dystrophy gene therapy did not show clinical benefit, but biologics center director Peter Marks invoked totality of evidence to grant full approval.

Approvals Gene Therapy
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