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Latest From Novan, Inc.

Marching On: Eight Novel Agents Among March Goal Dates For US FDA

Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.

US FDA Performance Tracker Approvals

As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

US FDA Performance Tracker Drug Review

Finance Watch: FibroGen, Amarin And Others Downsize To Survive

Restructuring Edition: FibroGen follows its clinical setback with a 32% reduction in force, cutting 104 jobs. Also, Amarin named a new CEO, but cut all US sales and 30% of non-sales US roles, and 9 Meters is headed for dissolution after Chapter 7 bankruptcy, while several others seek strategic alternatives.

Restructuring Business Strategies

Finance Watch: No Big Post-ASCO Follow-On Frenzy, But Biotech Had A Good Week

Public Company Edition: Follow-on offerings did not surge after ASCO, but Day One and Cogent raised $150m-plus. Also, IQVIA and Ionis sold $1.25bn and $500m in notes, while Krystal and Lexicon grossed $160m and $125m from post-approval offerings.

Financing Growth
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