Pharmaceutical Executive Daily: Treasury Issues Notice to Add Biotech into Proposed COINS Act

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, the Treasury Department proposes adding biotechnology to its Outbound Investment Security Program under the COINS Act, a pharma funding roundup covers Gilead’s $1.275 billion acquisition of an oral IL-23R inhibitor from PepStar and Zymeworks’ licensing deal with Roche for its DLL3-targeting T cell engager, and Incubate’s John Stanford argues that MFN deals are voluntary in name only.

The U.S. Department of the Treasury issued a Notice of Proposed Rulemaking adding biotechnology to the list of sectors subject to its Outbound Investment Security Program under the COINS Act, extending national security review into cross-border pharma licensing and investment activity. MassBio CEO and president Kendalle Burlin O’Connell says the biotech trade group is reviewing the proposal and plans to submit comments before the rule is finalized. Treasury is accepting public input before issuing final implementing regulations.

Two deals closed this week in immunology and oncology. Gilead Sciences entered a definitive agreement to acquire PepStar Therapeutics’ oral IL-23R inhibitor program, including lead asset HCXT-2001, for $1.275 billion in upfront cash, adding the Phase I peptide inhibitor to its inflammatory bowel disease pipeline. Separately, Zymeworks licensed its DLL3-targeting T cell engager ZW209 to Roche in a deal including a $55 million upfront payment, a $40 million milestone tied to Phase Ib initiation, and up to $718 million in additional milestones plus tiered royalties.

Finally, Incubate executive director John Stanford contends that Most-Favored Nation drug pricing deals are voluntary in name only, comparing the pressure companies face to “an offer you can’t refuse” given the threat of Section 232 tariffs and reference-pricing frameworks. He warns that the resulting risk aversion discourages companies from pursuing ambitious “moonshot” therapies, with cancer and Alzheimer’s already showing reduced innovation investment under the IRA.

Thanks for listening to Pharmaceutical Executive Daily. For more updates and in-depth analysis, visit PharmExec.com.