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Biotech Hangout

Episode 173 - February 20, 2026

59 min episode · 2 min read
·

Episode

59 min

Read time

2 min

Topics

Investing, Fundraising & VC, Leadership

AI-Generated Summary

Key Takeaways

  • China out-licensing acceleration: China out-licensing deals hit $137.7B in 2025 across 186 transactions, with Novartis, Merck, and GSK among the largest participants. In early 2026 alone, 38 deals totaling $1.3B have closed, with deal sizes up 76% and upfront fees doubled year-over-year. Pharma scouts should expect premium pricing, not arbitrage opportunities, going forward.
  • FDA regulatory instability risk management: Nine companies reported FDA reversals after receiving prior alignment on trial designs, with Vinay Prasad reportedly involved in at least six. Investors and executives should avoid building probability-of-success models contingent on current FDA flexibility policies, as leadership continuity over a four-to-five-year drug development timeline cannot be assumed under present conditions.
  • Keytruda patent runway to 2033: Bloomberg Intelligence patent attorneys, who accurately predicted Humira's 2023 expiry years in advance, now project Keytruda protection through 2033, with formulation patents potentially extending to 2039. This flattens Merck's revenue cliff, preserves capital for M&A, and delays biosimilar competition — with meaningful downstream effects on IO combination trial costs.
  • Single-trial FDA approval pathway: Marty Makary and Vinay Prasad co-authored a New England Journal editorial formalizing one pivotal trial as the FDA's default approval standard, citing existing statutory authority and oncology precedent. Companies should monitor whether regulatory actions align with this stated policy before restructuring development programs around single-trial designs, as implementation remains unproven.
  • Psychedelic therapeutics commercial viability: Compass Pathways reported positive phase three results for COM360 psilocybin in treatment-resistant depression across two trials, with durable response data and manageable safety signals. J&J's Spravato generating approximately $2B annually despite a two-hour in-office dosing requirement signals commercial precedent for psilocybin, which offers longer dose spacing and stronger durability advantages.

What It Covers

Biotech Hangout Episode 173 covers China's record-breaking out-licensing deal surge, FDA instability under Marty Makary and Vinay Prasad including the Moderna vaccine reversal, XBI market sentiment, Keytruda patent protection extending to 2033, and positive phase three data from Compass Pathways in treatment-resistant depression.

Key Questions Answered

  • China out-licensing acceleration: China out-licensing deals hit $137.7B in 2025 across 186 transactions, with Novartis, Merck, and GSK among the largest participants. In early 2026 alone, 38 deals totaling $1.3B have closed, with deal sizes up 76% and upfront fees doubled year-over-year. Pharma scouts should expect premium pricing, not arbitrage opportunities, going forward.
  • FDA regulatory instability risk management: Nine companies reported FDA reversals after receiving prior alignment on trial designs, with Vinay Prasad reportedly involved in at least six. Investors and executives should avoid building probability-of-success models contingent on current FDA flexibility policies, as leadership continuity over a four-to-five-year drug development timeline cannot be assumed under present conditions.
  • Keytruda patent runway to 2033: Bloomberg Intelligence patent attorneys, who accurately predicted Humira's 2023 expiry years in advance, now project Keytruda protection through 2033, with formulation patents potentially extending to 2039. This flattens Merck's revenue cliff, preserves capital for M&A, and delays biosimilar competition — with meaningful downstream effects on IO combination trial costs.
  • Single-trial FDA approval pathway: Marty Makary and Vinay Prasad co-authored a New England Journal editorial formalizing one pivotal trial as the FDA's default approval standard, citing existing statutory authority and oncology precedent. Companies should monitor whether regulatory actions align with this stated policy before restructuring development programs around single-trial designs, as implementation remains unproven.
  • Psychedelic therapeutics commercial viability: Compass Pathways reported positive phase three results for COM360 psilocybin in treatment-resistant depression across two trials, with durable response data and manageable safety signals. J&J's Spravato generating approximately $2B annually despite a two-hour in-office dosing requirement signals commercial precedent for psilocybin, which offers longer dose spacing and stronger durability advantages.

Notable Moment

Following Moderna's refused-to-file letter for its mRNA flu vaccine, Marty Makary was reportedly summoned to the White House, where the president expressed displeasure with the agency's handling of the matter. Within days, the refusal was rescinded — a timeline described as virtually unprecedented in FDA procedural history.

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Episode Transcript

You're listening to the biotech hangout, a live and unedited weekly discussion of all the latest news on our industry with a a group of biotech leaders and experts. I'm Eric Schmidt, and my cohost today are Sam Pizzelli, Paul Matisse, Craig Shneva, and, Luba Greenwood. For more information about our hosts and guest speakers or to listen to the most recent episode, you can go to the biotechhangout.com. Well, thanks everyone for for joining today. It is a short ish week, but but a busy week. And I think, because we didn't have biotech hangout last week, we're gonna dip back into the bag a little bit and and pull out some topics, from the prior week to discuss as well. So we've got a pretty busy agenda lined up. We're gonna start, with some discussion of the markets, deal flow, fundraising, and biotech, and and maybe a discussion of the index itself, the XBI, and and kind of where it's where it's heading, what might be needed to, to get to better performance. We'll we've got a lot to talk about with regard to the FDA, a ton of updates, some good, some bad, some indifferent. So we'll spend a fair bit of time, going through all the machinations of the agency, and then, we'll conclude with some company specific updates. And there wasn't as much data this week as in prior weeks, but we've got some clinical datasets to to cover as well. So that's the agenda for today. Let's start with a little bit of a market look. And and, Luba, I think you were gonna walk us through some of the more interesting licensing and, and fundraising deals that occurred this week. Yeah. Thanks so much. And the focus this week, and, you may have seen quite a lot of articles written on this, is on China. So we saw a number of reports this week showing a major uptick in China for out licensing deals already this year. We're still only, in mid February right now. Because of patent clips and r and d cut costs, that is has been the, driver, of pharma companies to scout in China. China out licensing has hit a record, last year of being about a 137,700,000,000.0, with major pharma such as Novartis, Merck, and GSK doing some of the biggest deals in China last year. And the total number of deals was 186. We already just in this year, have, seen 38 out licensing deals in out of China. We have seen already deal size that has jumped by 76%. Upfront fees have doubled. So if you're going to China thinking you're gonna get a deal, that's not like not likely. You're gonna get some innovative assets, but they're gonna be expensive. Deals just this year in 2026 have reached 1,300,000,000.0. Just this month, we've seen AstraZeneca do a deal for weight loss, which was, valued at about 18,500,000,000.0. AbbVie has just done a deal, licensing deal …

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Books, tools, and gear mentioned in this episode

SignalCast may earn commission on purchases via these links. As an Amazon Associate, SignalCast earns from qualifying purchases.

Tools

  • by Bloomberg

    Bloomberg Intelligence patent attorneys, who accurately predicted Humira's 2023 expiry years in advance, now project Keytruda protection through 2033

Products

  • by Compass Pathways

    Compass Pathways reported positive phase three results for COM360 psilocybin in treatment-resistant depression across two trials
  • by Johnson & Johnson

    J&J's Spravato generating approximately $2B annually despite a two-hour in-office dosing requirement signals commercial precedent for psilocybin

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