The FDA published briefing documents ahead of advisory committee meetings for Capricor Therapeutics’ Duchenne muscular dystrophy therapy and Replimune’s advanced melanoma drug indicating an uphill battle for the biotechs; GSK and AstraZeneca outlined ambitious plans in second quarter presentations; Sarepta tapped Michael Severino as its new CEO; and Amgen launched its official defense of Tavneos.

Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more 

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Welcome to The Weekly. I'm Heather McKenzie, filling in for Jeff Axe. This week is all about adcoms and earnings. The FDA released briefing documents for two advisory committee meetings taking place today and tomorrow, and it's looking like both Replimune and Capricor are in for a tough slog.

Meanwhile, GSK, AstraZeneca, and Roche announced Q2 results. Sarepta has a new CEO, and Amgen has launched a full-court press to defend its embattled rare disease drug, Tavenios. Let's get started. Hi, Annalie. Welcome back. Hi. Thank you. Yeah, I feel like... Have I been off the podcast for two weeks? Three weeks?

Three weeks. Yeah, I don't think... Yeah, we missed you. But how was your vacation? How is your garden looking now? My vacation was good. It was a little long, but it was nice. And yeah, I came back. I had somebody taking care of my garden the whole time. But it turns out I've been lovingly nursing a weed, which is now five feet tall in my garden. I thought it was a dahlia. It's not. Maybe you could get it classified as something else, like a new flower.

Well, I wish, but it does already have a name. It's apparently called pigweed. Okay. Yeah, yeah. It's a type of amaranth, which is a plant that some people grow for beauty, but not this particular variety. It's just a weed. So now I have to decide what to do with it because it's really tall and as tall as my other dahlia. Is it pretty? No. No. Yeah. Maybe it's run its course.

Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more

Read the full transcript

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

Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more

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.