Another Cytokinetics own goal leaves investors fuming

From my colleague Adam Feuerstein: Cytokinetics... argh.

The company committed an unforced error that has extended the review of its heart disease drug by three months, knocked down its stock price, and once again, triggered the ire of investors over questionable management decision-making.

We learned yesterday that the FDA wants to review a safety management plan for the Cytokinetics' drug, called aficamten. The problem: The company, inexplicably, never submitted one in its original application. Now it has, but the FDA needs an extra three months to review it.

As a result, the expected approval decision date for aficamten was pushed back to Dec. 26 from Sept. 26.

Cytokinetics shares are down and investor are angry.

politics

Biotech industry gets candid about politics at Stanford

Biotech leaders gathered at Stanford’s Drug Discovery Symposium in Palo Alto this week to voice growing alarm over the Trump administration’s disruption of science — from sweeping FDA layoffs to NIH grant cuts to the hollowing out of diversity initiatives. The uncertainty is alerady reshaping R&D strategies, STAT’s Jonathan Wosen writes, along with funding decisions and clinical trial locations.

Juxtaposed with the maelstrom that is AI, the industry is unsure quite how to proceed: “I’ve never been more optimistic on the one hand about our ability to innovate and have impact,” Amgen CEO Robert Bradway said. “But I’ve never been more concerned about the ecosystem in which that innovation occurs.”

REGULATION

FDA rehires fired staff amid mounting backlash

In a chaotic about-face, the Food and Drug Administration is quietly reinstating dozens of laid-off employees — including travel coordinators, food scientists, and FOIA staff — after the sweeping round of DOGE-initiated layoffs slashed about 20% of its workforce. The abrupt rehiring comes as the agency scrambles to meet legal deadlines and maintain core safety operations.

Despite Commissioner Marty Makary’s repeated claims that no FDA scientists were affected, at least two dozen food safety researchers were let go, only to be told they may now return.

“I hope Commissioner Makary continues to assess these ill-informed cuts and works to bring back impacted employees expeditiously,” said Susan Mayne, a former food director at FDA. “His legacy as commissioner is on the line.”

podcast

The impact of Trump's first 100 days on biotech

On this week’s episode of the Readout LOUD, we review President Trump’s first 100 days, the return of biotech M&A, strong drug launches, and Eli Lilly’s PBM problem. The first 100 days of the Trump administration have had a profound impact on federal health agencies, medical research, health policy, and the biotech and pharmaceuticals industries.

To help us make sense of all the cuts and policy shifts, we talk with STAT editors Gideon Gil and Zach Tracer for their perspective overseeing STAT’s reporting on science and politics.

But first, your hosts, Elaine, Allison, and Adam, gab about the week’s relatively positive biotech news, including two acquisitions and a series of strong drug launches. What’s a podcast without dipping into obesity, so Elaine will explain the latest maneuverings between Eli Lilly and Novo Nordisk around patient access and compounding.

Listen here.

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