Pharmaceutical Industry Roundup: Janux Setback, FDA Reviews, and Leadership Changes

Janux Therapeutics Faces Setback in Prostate Cancer Trial

Janux Therapeutics experienced a significant stock price drop of nearly 50% following the release of new early-stage results for their "masked" T cell engager, JANX007, in advanced prostate cancer treatment. The latest data revealed a response rate of 30% among 27 evaluable patients, a decrease from the 50% response rate reported in December. This decline has raised concerns among investors, although some analysts, such as William Blair's Matt Phipps, suggest the selloff may be an "overreaction."

Despite the setback, Phipps noted that patients treated with the dosing regimens advancing into further testing, or those with lower tumor burden, still showed promising results. He maintains that JANX007 could potentially have a "best-in-disease profile."

FDA Developments and AstraZeneca's Baxdrostat Review

The pharmaceutical landscape sees movement on the regulatory front as the FDA begins its review of baxdrostat, a blood pressure medication acquired by AstraZeneca through its 2023 buyout of CinCor Pharma. The agency has granted baxdrostat priority review for treating hard-to-control hypertension, with a decision expected in the second quarter of 2026.

AstraZeneca has high hopes for baxdrostat, projecting potential billions in yearly sales. The drug is also under investigation for primary aldosteronism and in combination with Farxiga for chronic kidney disease and heart failure prevention.

Leadership Changes and Vaccine Advisory Panel Updates

In a significant shift, the U.S. Department of Health and Human Services has appointed Martin Kulldorff as the chief science officer for its in-house policy guidance group, ASPE. Kulldorff, who previously chaired the influential Advisory Committee on Immunization Practices (ACIP), has been replaced in that role by Kirk Milhoan.

Milhoan, a pediatric cardiologist, has been critical of COVID-19 vaccines and has advocated for the use of controversial treatments like hydroxychloroquine and ivermectin. This change comes just days before a key ACIP meeting to discuss the childhood immunization schedule and hepatitis B shots.

Eli Lilly Adjusts Zepbound Pricing Strategy

Eli Lilly has announced a price reduction for its obesity drug Zepbound, specifically for cash-paying customers using its online channel. The new pricing structure sets the monthly cost at $299 for a starter dose, with a maximum of $499 for subsequent doses. This adjustment follows a recent agreement with the Trump administration to lower Zepbound's average monthly cost to $346 when purchased through a U.S. government cash-pay portal.

The price changes affect various dosages of Zepbound, with the 2.5 milligram weekly starter dose now priced at $299, down from $349, and the 5 milligram dose reduced to $399 from $499. All other doses will be priced at $449.