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.

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.

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.

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.