CymaBay maps out regulatory filing for primary biliary cholangitis drug seladelpar

Regulatory applications in EU and the UK will follow a potential filing in the US in early 2024.

Latest news

Glenmark Pharma to divest 75% stake in life sciences unit for $680m

Following the divestiture, Glenmark Pharma will own a 7.84% stake in GLS.

FDA accepts Takeda's NDA resubmission for eosinophilic esophagitis therapy

The company is expecting a decision from the regulator in the first half of next year.

Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine

The collaboration will use Evaxion’s EDEN platform to bring AI-designed mRNA vaccine to the market.

Yale and Transcend wins US DoD grant for PTSD therapy

The Department of Defense grant is to study methylone for the rapid and long-lasting treatment of PTSD.

Medicenna to expand Phase III glioblastoma trial globally

Medicenna is also starting to enrol patients in an ongoing Phase I/II trial in solid tumours investigating dose expansion of MDNA11.

Kezar and Everest enter lupus nephritis therapy development deal

Kezar is eligible to receive up to $132.5m in initial upfront and milestone payments.

Gilgamesh completes SAD and MAD studies of MDD therapy

The company plans to commence a Phase IIa study in MDD patients in the second half of this year.

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