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CNS

Set Alert for CNS

Intra-Cellular Poised To Add MDD To Caplyta’s Label

Caplyta succeeded in a second Phase III study as adjunctive therapy for major depression, putting the schizophrenia/bipolar disorder drug on track for sNDA filing later in 2024.

Clinical Trials Business Strategies

Marinus Considers Its Options After Mixed Phase III Data

Ganaxolone met one of two endpoints in its Phase III refractory status epilepticus trial, but next steps are uncertain. Analysts say the firm should focus on a more promising trial, but Marinus thinks conditional approval is possible.

Clinical Trials Drug Approval Standards

Takeda’s Soticlestat Fails In Seizure Trials

Two Phase III studies testing soticlestat, licensed from Ovid, in Dravet and Lennox-Gastaut syndromes failed to meet their primary endpoints on improvement in seizure frequency.

Clinical Trials Neurology

US R&D Setbacks For Multiple Japanese Firms

Several Japanese firms are facing R&D challenges and setbacks in the US, in the form of missed Phase III endpoints, trial recruitment difficulties and a Complete Response Letter.

Research & Development Clinical Trials

New Promise, Looming Competition For DMD In China

With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.

China Clinical Trials

Bukwang Adds To Stacking Mid-Stage Failures In Parkinson's

Bukwang and subsidiary Contera have become the latest to fail to progress a novel Parkinson's therapy to late-stage trials after a Phase II miss, although several other Korean firms remain in the race for the challenging indication, albeit mainly in Phase I-II.

South Korea Clinical Trials

Rapport Navigates Rough IPO Market With Well-Received Offering

Rapport Therapeutics launched an initial public offering in the middle of a proposed price range, and the CNS-focused company closed slightly above its IPO price on its first day of trading.

Financing Business Strategies

BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More

Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.

BIO Deals

Despite Trial Failure, NRx Leads In Bipolar

ANALYSIS: Few companies are pursuing therapies for bipolar disorder, but the few ongoing trials will yield data very shortly.

Clinical Trials Companies

Early Results Erode Belief In Biohaven’s Protein Degrader

Phase I results from BHV-1300 underwhelmed investors, but Biohaven is moving ahead and has many more shots on goal in protein degradation and beyond.

Clinical Trials Companies

Bristol Opts In On Second Neuro Candidate Under Prothena Alliance

Neither the mechanism nor indication is disclosed, but BMS is paying $80m up front for global rights to PRX019, which one analyst speculated might be an Alzheimer’s candidate.

Deals Business Strategies

China Biotech CEO Interview: Starting A CNS Venture In An Economic Downturn

From Wyeth/Pfizer to Jiangsu Hengrui to IMab to starting her own biotech, Joan Huaqiong Shen has seen many ups and downs of drug development in China. She sat down with Scrip on the sidelines of the recent DIA China meeting to discuss her latest startup devoted to novel small molecules to treat schizophrenia and epilepsy and a gene therapy for ALS.

China Research & Development
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