September 3, 2025

The need-to-know this morning

Wave Life Sciences reported updated results from a mid-stage study of its RNA-editing treatment for the serious lung condition alpha-1 antitrypsin deficiency, or AATD.

exclusive

Gilead wants to hike price of HIV meds distributed by states

Gilead Sciences is looking to significantly boost the price of several HIV treatments that are distributed by state programs, threatening their financial stability, my colleague Ed Silverman exclusively reports.

These state AIDS Drug Assistance Programs currently provide free or low-cost medicines to about 110,000 low-income people nationwide with HIV and AIDS who lack sufficient health care coverage.

Program directors are unnerved by Gilead's proposal. It comes as the Trump administration is already seeking to cut funding for HIV prevention programs, which could lead to new HIV infections that would likely boost demand for medicines and services provided by the state programs.

market check

Biotech stocks did well yesterday

In a development rarely seen this year — the XBI, the closely watched index of biotech stocks, rose over 3% yesterday, outperforming the SPY, which tracks the S&P 500, and the QQQ, which tracks tech companies. The move was driven by some biotech companies that reported positive data in recent days.

Cytokinetics showed over the weekend that its experimental heart drug outperformed commonly used beta blockers in patients with obstructive hypertrophic cardiomyopathy. Its stock surged 40% yesterday.

Meanwhile, Ionis Pharmaceuticals reported yesterday that its rare disease drug lowered the triglycerides of patients with a common condition, opening up a potential blockbuster opporunity for the company. Ionis' stock climbed 35%.

Shares of United Therapeutics rose 33% after it released positive results yesterday of its inhaled medicine Tyvaso in patients with idiopathic pulmonary fibrosis.

vTFET-biotech-stocks-outperform-broader-market(1)

But was yesterday an anomaly or a signal that the industry could see more upside?

In a note, Mizuho analyst Jared Holz wrote that while much of the market moves yesterday were due to short positions being reduced or closed, "there is growing evidence of a continued recovery for the space in total."

infectious disease

Experts fear 'emboldened' ACIP may revisit RSV antibodies

Now that health secretary Robert F. Kennedy Jr. has ousted CDC Director Susan Monarez, public health experts fear that the agency's advisory committee on vaccines may propose fundamental changes to childhood infectious disease policies that don't align with scientific consensus — and that those recommendations will be adopted.

The panel, called the Advisory Committee on Immunization Practices, could "be very much emboldened to make more aggressive changes," said a former chair of the group.

In particular, experts fear that the ACIP, which consists of members hand-picked by Kennedy, may roll back a recommendation that it made last meeting in support of a preventive monoclonal antibody developed by Merck that protects infants against RSV.

Since the last meeting, one member, Robert Malone, has posted an analysis that questions the data that CDC presented on Merck's antibody and wrote that he no longer trusts what the agency presents to the committee.