STRATEGIC NEWS WATCH — September 9, 2026
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HHS installed permanent directors at CDER and CBER for the first time since Patrizia Cavazzoni and Peter Marks departed, steadying the FDA’s two largest review centers from within. Separately, Revolution Medicines’ newly approved pancreatic-cancer drug Rasonque, priced at roughly $477,000 a year and more than double Keytruda’s list price, reopened the US drug-pricing argument. Today’s top developments:
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What to Watch
- What the two permanent directors do first — Davis at CDER and Mikhail at CBER now hold their posts permanently with no confirmed commissioner above them. Mikhail arrives from a commercial background rather than the regulatory or academic route into the center that sets cell and gene therapy policy, so early CBER decisions will be the first read on whether the appointment shifts review posture.
- Tozorakimab’s label breadth — The $3-5 billion peak-sales case depends on a broad COPD label rather than an eosinophil-restricted one, with the FDA decision expected in the first quarter of 2027 and no specific date published. The mucus-plugging claim is the only thing that clearly separates the antibody from Dupixent and Nucala, so whether it survives into the label is the number that matters.
- Whether Rasonque’s price draws a response — $477,000 a year against a roughly doubled median survival in metastatic pancreatic cancer is the pricing argument in its sharpest form. Watch payer coverage decisions and whether the drug is named in the next Medicare negotiation cycle, which is where a price at this level is actually tested.
- Porustobart’s therapeutic window — Solstice’s thesis rests on a four-to-five-day half-life concentrating activity in the tumor and limiting the systemic toxicity that has constrained the CTLA-4 class. The Phase 2 due to start by the end of 2026 in microsatellite-stable colon cancer — and specifically the immune-related adverse-event rate in combination with a PD-1 blocker — is what decides whether the re-engineering worked.
- KO-7246’s preclinical data at EASD — Caspian’s beta-cell regeneration data are due at the European Association for the Study of Diabetes meeting in Milan later this month and remain preclinical. Watch whether the effect holds in large-animal models, the stage at which earlier beta-cell regeneration programs have generally stopped.
This brief highlights the edition’s top stories. Read the full September 9, 2026 edition → for all stories and analysis — or browse the Strategic News Watch archive.