The Weekly Digest: What Went Down Last Week in Pharma

Welcome to The Weekly Digest, by Chakib Rachedi, PharmD, where I break down the latest developments in the pharmaceutical and biotech industries. If you’re looking for sharp insights and actionable takeaways, you’re in the right place!

This week’s updates feature regulatory moves, major acquisitions, and scientific advances that are reshaping the pharma landscape. Let’s dive in!

?? Medicare Price Negotiations Shake Up the Industry

The Centers for Medicare & Medicaid Services (CMS) unveiled 15 new drugs set for price negotiations under Medicare Part D by 2027. While most selections were predictable, surprises like Teva’s Austedo reveal CMS’s aggressive approach to controlling drug costs before their loss of exclusivity (LOE).

?? Key Insights:

• Nine of the selected drugs face LOEs by 2029, minimizing long-term pricing impacts.
• Novo Nordisk’s semaglutide (Ozempic, Wegovy) and AstraZeneca’s Calquence are among those with later LOEs, signaling extended pricing risks.
• Industry backlash highlights systemic issues with middlemen in the pharmaceutical supply chain, as rebates and PBM practices continue to raise costs for patients.

?? STAT6: The Next Frontier in Inflammatory Disease Treatment

Gilead Sciences joined the STAT6 race through its partnership with LEO Pharma, acquiring rights to preclinical oral STAT6 inhibitors and degraders. This move reflects the growing momentum behind STAT6 as a target for Th2 inflammatory disorders like asthma and eczema.

?? Key Insights:

• STAT6 inhibitors may redefine treatment paradigms, akin to an “oral Dupixent.”
• Gilead follows in the footsteps of Johnson & Johnson, Sanofi, and Kymera Therapeutics, signaling robust competition in this space.
• Kymera’s KT-621 program, with Phase I data expected in 2025, leads the pack, underscoring the importance of early-stage innovation.

?? J&J Acquires Intra-Cellular Therapies to Expand CNS Portfolio

Johnson & Johnson’s $14.6 billion acquisition of Intra-Cellular Therapies strengthens its foothold in the CNS market with the addition of Caplyta, approved for schizophrenia and bipolar disorders. Analysts forecast significant sales growth, particularly if FDA approval for major depressive disorder (MDD) is secured by late 2025.

?? Key Insights:

• Caplyta’s potential MDD approval could generate $1.4 billion in peak sales by 2033.
• J&J’s strategy reflects the increasing demand for innovative CNS treatments amidst rising mental health concerns globally.
• A potential extension of Caplyta’s LOE to 2040 underscores its long-term value.

?? Keros Faces Setback as TROPOS Trial Halts

Keros Therapeutics terminated its Phase II TROPOS trial for cibotercept after safety concerns related to pericardial effusions. This marks another blow to the company’s PAH program, dampening investor confidence.

?? Key Insights:

• Safety issues in high-dose and low-dose arms led to the trial’s cessation.
• Despite the setback, Keros plans to prioritize other programs like KER-065 for Duchenne muscular dystrophy.
• With shares trading below cash, Keros faces significant pressure to rebuild market trust.

Final Thoughts

This week highlighted the dynamic interplay of regulatory shifts, strategic acquisitions, and scientific advances in pharma. As companies navigate pricing pressures and safety challenges, innovation remains the industry's cornerstone.

?? Stay informed and stay ahead—Share & Follow for more on the pharmaceutical industry!