The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.

Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water

BioSpace

Hello, and welcome to BioSpace's The Weekly. I'm Jeff Axt, Managing Editor, and we just returned from covering bio in San Diego. I was out there with Annalie Armstrong, so we'll have a lot to talk about in terms of the regulatory and business environments facing biopharma at the moment. The good news is that sentiment is overwhelmingly positive, but it is nuanced, so we'll get into that in a little bit. In today's show, we'll also address the biggest headline of the week so far, the retraction of a pivotal study for Amgen's rare disease drug, Tavneos.

It's been on the FDA's radar since January when the agency requested that Amgen pull the drug from the market, but now the pivotal study published in the New England Journal of Medicine has been retracted. Finally, it's officially the start to the second half of the year, so we'll take a look back at the deals struck so far and what it means for the overall health of the industry. Let's dig in. Hi everyone! How are y'all doing? Annalie, do you feel recovered from our week in San Diego?

Annalie Do, yeah. You know, I had a smooth travel experience. As everybody who I've talked to at any of these conferences knows, that is never the case. So, yeah, feeling good. Annalie That's a literal miracle, Annalie. Annalie I know. Annalie And by the way, welcome back and thank you for coming back. Yeah, it was a long week. You guys were so helpful even, you know, with news from San Diego. I couldn't believe how, you know, how smooth it actually went. Annalie You two were hustling. We could tell.

Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water

Read the full transcript

The candid version is on a podcast,
not the earnings call.

Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.