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SpringWorks Therapeutics Inc.

Latest From SpringWorks Therapeutics Inc.

With One Launch Under Way, SpringWorks Ramps Up For A Second

The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.

Launches Business Strategies

NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In

Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.

Europe Liver & Hepatic

Real-Time Oncology Review Speeds Supplements At US FDA, But Gives Modest Benefit For Novel Agents

US FDA’s 72 approvals under streamlined submission program consistently come before the PDUFA goal date, Pink Sheet analysis shows, but benefit ranges from 2 weeks for priority review novel agents to 1.8 months for other priority applications.

US FDA Performance Tracker Pink Sheet Perspectives

Finance Watch: Stark Contrast As Big FOPOs Reach Market, Other Firms Cut Costs

Public Company Edition: Arvinas grossed $350m in a private placement, while Xenon brought in $345m and Pharvaris raised $300m in follow-on public offerings. Fundraising remains challenging, however, so IGM Biosciences, Hansa Biopharma and other companies cut costs to save money.

Financing Business Strategies
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • MapKure, LLC
    • SpringWorks Therapeutics, LLC