

13 Sep 2026 · 31m · 13 chapters

Why biotech stocks (measured by SPDR S&P Biotech ETF XBI) have surged ~70% over the past year, and whether the rally can last. The episode links the move to policy shifts around drug pricing, rotation from AI mega-cap trades into healthcare, and recent cancer/news catalysts; it also weighs risks like biotech “binary” outcomes, valuation, M&A limits, and China competition.
David Wehner, Heard on the Street columnist at The Wall Street Journal; covers investing in health care, biotech, and pharma.
Trump-era drug-price regulation fears eased after late-2025 agreements with pharma CEOs; this improved sentiment. AI hasn’t directly driven drug breakthroughs, but investors rotated toward biotech as an alternative to expensive AI/tech. Big pharma M&A is less favored by investors now, and Wehner argues Revolution Medicines won’t be acquired.
Moderna melanoma mRNA vaccine showing reduced recurrence/spread; Revolution Medicines FDA approval for pancreatic cancer; Keytruda (Merck) challenged by Chinese data; Unicure Huntington’s gene therapy facing FDA scrutiny and upcoming four-year data.
Written by AI. May contain mistakes.
Discussion on biotech's surprising outperformance and key drivers.
“And of course, what was I doing on the beach?”
Introduction of David Wehner and insights into the biotech rally.
“We have an in-house expert right here at The Wall Street Journal.”
Analysis of how Trump's policies initially harmed biotech stocks.
“Because Trump ran on this platform that he was going to rein in drug prices.”
Exploration of changing sentiments in biotech and pharma stocks.
“And there's debate about how impactful that is.”
Discussion of recent breakthroughs in cancer treatments and their implications.
“So as the market gets more concerned about AI valuations and starts thinking like this thing is looking toppy, this thing is looking highly expensive.”
Exploration of the long-term potential and risks of biotech investments.
“So there's this kind of like, well, it's still got a long way back to where it was before.”
Discussion on big pharma's acquisition strategies and market risks.
“And it's always a question with biotech.”
Discussion on the potential of AI in healthcare and drug development.
Explore how AI is influencing drug development and investor perceptions in biotech.
“Is AI actually going to help with some of the development of these drugs?”
Learn about the advantages of index investing in the biotech sector.
“So it seems like this is a place where, like, index investing is really the way to go.”
Understand the potential impact of China's fast-moving drug development on US biotech companies.
“China could kind of threaten to undo it all because China's really very fast moving in its drug development.”
Discover the implications of new cancer treatments and their competitive landscape.
“Has there been a deep seek moment in the market, like the way that the sudden emergence of a Chinese AI model that was maybe as good as the ones you know, caused the market to crash?”
Explore the ethical debate surrounding FDA trials and access to experimental drugs.
“You know, it's just like they're taking data from a handful of patients and comparing it to sort of patients outside who aren't taking the drug.”

Get the gist, explore an idea or ask about something said.
On WSJ's Take On the Week, what are the key points of this episode?
Automatic transcript. May contain errors.
0:00Telis Demos: Tomorrow's opportunities start by seeing beyond the surface. Global X ETFs combine deep research and global expertise to uncover the forces shaping markets. Explore ETFs for investors who lead with conviction at GlobalXETFs.com. Hi, Miriam. Hi, Telis. So I was out for a couple of weeks. And of course, what was I doing on the beach? I was catching up to take on the week. I was listening to the episode that you did. I'm such a devoted co-host, I really have to say. You know, not just a co-host, but also a listener, as I like to say. But in all seriousness, the episode about small caps was really interesting.
0:37Telis Demos: And one thing that jumped out to me was that the guest talked about, Dan Rasmussen talked about how one driver of small caps outperformance has been biotech. And that caught me because my, you know, kind of understanding was that biotech had been underperforming for a long time. So it turns out that's not the case recently. It is definitely not the case. In fact, as of this recording, XBI, which is the big biotech ETF, is up about 70 percent over the past year versus about 20 percent for the S &P 500. So that's a really significant outperformance. Well, and I guess it didn't surprise me ultimately, right?
1:12Telis Demos: Because when we talk about biotech, we're talking about companies developing new drugs, right? The kind of tech companies of the health care world. That's right. And what have been in the headlines recently? I mean, we have what? Basically a cancer vaccine now in development, right? We have incredible breakthroughs all the time. So I guess it makes sense that the stocks would reflect that, right? I think so. And I wanted to dig into that more. And, you know, we thought, oh, we could bring in some Wall Street analysts. And then we thought, you know what? We have an in-house expert right here at The Wall Street Journal.
1:44And that is Heard on the Street columnist David Wehner, who writes incredible commentary about investing in health care, including biotech and pharma. And he is joining us here today. Welcome, David.
1:55Telis Demos: Thank you. I'm so happy to be here. Obviously, there's been a lot of really exciting news in the biotech world, but I'm sure it's not so simple as like drug news, stocks go up. So why don't you catch us up? What has been happening to drive the rally in biotechs? And we're measuring it by, just for listeners' ease, the SPDR S &P Biotech ETF XBI. That's the one that's really just been gangbusters over the past year. What's driving that? So to understand what's going on in biotech and pharma, you have to go back to when Trump was elected for the second time, right? Because Trump ran on this platform that he was going to rein in drug prices.
2:35And more importantly, he brought in RFK Jr. as his health secretary, right? So there was absolute panic in the biopharma world when these folks came on. And stocks actually fell as a reaction to them? Stocks fell, yeah.
2:50Telis Demos: And that's just because the Maha agenda was like very anti-vaccine and everything. Yeah, they were anti-vaccine. There was concern that there was like this sort of big anti-big pharma, you know, wing within the Trump camp. And then on top of it all, Trump was actually talking about drug price regulation. He has this thing called most favored nation that he wanted to basically say, you guys can no longer charge more than what you charge European countries or Japan or something like that. So the sentiment was very negative. And then somewhere, you know, as we've seen with the taco trade, you know, in many parts of our economy.
3:23That's Trump always chickens out for those who have not been following. Right. Eventually, in late 2025, Trump signs these agreements, starting with Albert Bourla, the CEO of Pfizer, basically declaring the whole thing over. Tariffs are off. Drug pricing regulation is agreed upon. And there's debate about how impactful that is. So he went through each of the pharma CEOs and signed a pact with them? Right, exactly. He started with Pfizer CEO, and then there were like these group signings at the White House every other day. At some point, everybody stopped paying attention. And that just lifted pharma stocks and gradually started to lift biotech stocks as well.
4:03And we can get into that.
4:04Telis Demos: Well, just very quickly, what is the difference between a pharma stock and a biotech stock? What's the demarcator there? You know, the big pharma stocks are the like big, you know, scaled global companies. They're no longer really good at innovating. They're really good at acquiring companies. And this is really important. Right. And then you've got like smaller and medium sized biotechs. They're like, maybe they got one really important drug. Maybe they have a platform like Moderna. We can talk about that later. And you've got these like large biotech companies. I guess we like Amgen and Gilead.
4:34Eli Lilly would be thought about as a big pharma company. That's now famously a$1 trillion company. due to the GLP-1 thing. You know, companies like Gilead, they're still in the sort of$200,$300 billion and less, you know, market caps.
4:49Telis Demos: And has pharma been rallying as well alongside the smaller kind of biotech companies? Big pharma's definitely rallying as well. Yeah. And what's interesting there, and this is all kind of ties together, not only did the sort of the policy headache go away, Trump stopped talking about tariffs on drugs. he stopped talking about controlling drug prices. So suddenly Wall Street's going like, okay, the field's clear. We now have a clear view into the future, or as clear as it's going to get for the next couple of years. But also the AI trade is becoming more and more linked to healthcare trade. So as the market gets more concerned about AI valuations and starts thinking like this thing is looking toppy, this thing is looking highly expensive.
5:34I see. They're looking for alternatives. Yeah, and health care, which was kind of back here, partly because of policy, but also partly because AI was driving all the investment. Now it's sort of like money is rotating. Which really ties into what Dan Rasmussen was talking about. AI and biotech were sort of like the speculative fuel behind the small cap rally as well, because people were looking for alternatives to the big hyperscalers in the market. But I do want to talk about, you know, the two big cancer breakthroughs that occurred last month. Moderna showed that its experimental melanoma vaccine was working to stop cancer coming back or spreading in high-risk patients.
6:13And then Revolution Medicines got FDA approval for its pancreatic cancer treatment. But would you say that they are now appropriately priced or have investors gotten out over their skis? That's a great question, right? And that's always the difficult questions with these stocks. You know, I think both companies are very exciting for investors because they have platforms, right? Like the idea is that in the Moderna side, you have this mRNA platform, right? We saw it with the COVID vaccines. Now we're seeing it with cancer treatments. So investors sort of start to think, wow, this could really apply to a lot of things.
6:47And remind us, what's like the overview of how mRNA works? Is there like a quick description of that? In the case of the vaccines, I think what's really exciting is you're building these personalized therapies. And, you know, sometimes people call it vaccines. They're really more like therapies. And you're really taking the tumor and you're looking for the mutations. And then you're building a therapy based off of that to target the cancer. But it's really by activating your own immune system, kind of like with the COVID shots. Right. So it's telling your immune system to go like an attack dog and hunt the cancer.
7:21So investors kind of see, okay, if they could do this with one cancer, maybe they could do this with another cancer. Absolutely. And so the rally that we saw, and I think obviously it depends where the stock is today, but it added over$25 to$30 billion. It was like about a$20 billion company before the announcement. It's now a$50 to$60 billion. So that's more than double. Now, remember, Moderna used to be worth like$150,$200 billion during the pandemic. So there's this kind of like, well, it's still got a long way back to where it was before. So let's just keep buying the stock, right? Right.
7:53Telis Demos: I'm glad you raised that because this is, as just an observer here, you know, I think about, okay, we had incredible breakthroughs in recent years, too. We had, obviously, the COVID vaccine that came about through Operation Warp Speed. It was incredible. It suddenly arrived. You had Wegovy and the sort of, you know, weight loss targeting GLP-1s, right? But the stocks of the companies that innovated those things, like I guess BioNTech in the case of COVID-19 and Novo in the case of WeCoV was the first of those drugs, the stocks did OK for a while, but then went through years where they did terribly.
8:30Telis Demos: So is the market saying, OK, no, but this one, this cancer thing, this is the real thing and this stock's going to go up for a while? Or is this another like stock pops, it drops? I mean, that's how I think of biotech is like huge jumps, huge drops. It does have that reputation. Are we still in that dynamic, potentially? That's a great question, and I think maybe connects back to the other company you mentioned, Revolution Medicine. Look, I think Moderna will be going up and down for a while. It was Moderna and Merck that had this joint breakthrough. I think what Moderna has brought to the world is revolutionary.
9:04It's really exciting, and there's potential for sure. But the market definitely is attributing like a huge future revenue to this drug. And so, you know, I'd be careful with that one. It's not to say that Moderna's long-term prospects aren't really exciting. They are. And I'm a fan of the company and what they're doing. With Revolution Medicines, I think it's more of a clear case. Yes, the market's also very excited about it. But there is nothing for pancreatic cancer. It's like it's just. It's a deadly, deadly cancer. Yes. Yeah. And so now they've gotten this drug approved that, you know, really extends people's lives.
9:46It's still, you know, not going to be a cure for a long time. But the company has a huge platform of these so-called RAS drugs. And they're looking to tinker with that and improve that. And so it's more of a clear cut thing. If you believe. And it's always a question with biotech. And, you know, you can never say, like, buy this or sell this. These are binary bets for the most part. But if you believe in this platform and you see that, you know, this is going to be a huge market, this company, which is already now about a$50 billion company, could be one of those biotechs that becomes that sort of Gilead or Mgen that trades like at$100 billion one day.
10:24Telis Demos: I was going to ask, like, is there a precedent for a company that starts off with like a small platform or, you know, comes out with one thing and then, you know, has a long sustained kind of growth like into a mega kind of company? Absolutely. And, you know, that's that's the sort of like large biotech thing that we were talking about earlier. Names that come to mind are Amgen, Vertex, which has pioneered like treatments for cystic fibrosis, Gilead, which is now growing in HIV. So there's these companies, they come up with a few therapies, and normally big pharma goes and acquires. That's the model.
11:00But every once in a while, for whatever reason, either because no big pharma managed to get to it and then it got too expensive, or because a CEO or a founder team has very high conviction. They don't want to sell at any price, and the stock just runs up, and eventually they build it out on their own.
11:14Telis Demos: What do you think will happen here? Are we on the cusp of another big M &A wave where the giant pharma kind of platformer companies are going to snap up the revolutions of the world? I'm not asking for a call specifically on that, but do you think we'll see an M &A wave? That's a great question. I mean, I will make a call on that. Revolution of Medicine will not get acquired. And I think that's partly because a lot of big pharma companies are sort of tapped out. And it's really big now. It's big. Yeah. There's also been this whole change in perspective by investors. So like a few decades ago, big pharma companies, they'd see their patent cliff.
11:47And that's when like your drugs are going off patent and your revenues are about to go down a cliff.
11:52Telis Demos: Because somebody is going to make a generic and sell it for a fraction of the price. Exactly. So you've got to find something else. And they would often go and acquire another big pharma company, cut costs, fire a bunch of people, get rid of duplicate marketing costs. And, you know, investors would... Rinse and repeat. Yeah. You could do that formula for years and years. Did that generate value for shareholders? Not as much as people would have hoped. And so we saw reports that AstraZeneca was going to acquire Bristol-Myers, or was in talks to acquire, and AstraZeneca stock tank. Investors were sort of like, red card, no, you're not doing it.
12:24So people aren't really that hot on these big mergers anymore. They're not. They are in the recipe for big pharma CEOs right now. And I wrote about this recently is, you know, go to the supermarket when you're not too hungry. You know, like leave a little room. Like so go, you know, fill up your shopping carts, but with, you know, like smaller things. So meaning go for those biotech companies that maybe in a year or two will give you that data that will become the next big drug. Novartis has actually been one of these companies doing a lot of these smaller midsize acquisitions. But this past week, the stock tanked because of several data readouts from a couple of clinical trials of companies that partnered with or acquired that basically didn't work out.
13:08I guess that's kind of the risk of that strategy. It's more of a venture capital type approach, right? You're buying these small companies that are a bit unproven in the hopes that one of them is going to take you to the next level.
13:20Telis Demos: Exactly. I want to dig into that, but we need to take a quick break. When we come back, more with David Wehner of Heard on the Street.
13:31Telis Demos: What connects GlobalX ETFs with the advisors and investors who choose us? Conviction. The belief that vision returns value and innovation yields opportunity. Combining insights both local and global, we look beyond obvious trends to uncover the opportunities shaping tomorrow. Explore our funds at GlobalXETFs.com. Global X. Beyond Ordinary ETFs.
14:05Welcome back. David, I want to talk about AI. Is AI actually going to help with some of the development of these drugs? Because all I ever hear from investors is that healthcare and pharma are going to be some of the biggest beneficiaries of AI. But as far as I can tell, these Moderna and Revolution Medicine's breakthroughs didn't really have a lot to do with AI. No, you bring up a great point, and we can already see AI improving with clinical trial recruitment. Obviously, health technology is changing rapidly. Software around health care. The way we diagnose disease. People are already going on ChatGPT and saying, I've got this spot on my toe.
14:46Is that cancer? Is that a good thing? There's a huge debate around that as well, right? And some people are actually quite positive. Is this the new WebMD? The holy grail is like, will AI fundamentally revolutionize the way we develop drugs, we find cures? Yeah, will it be able to identify the cure for cancer that we can't find? Exactly. And there, I'm not saying I don't think it's going to happen, but I think you have to think of it as part of a bigger thing that needs to shift because, you know, we're talking about biology. In the end, we still have to test drugs in human bodies and we have to wait years and years and years.
15:20And AI can't accelerate that, not yet. So a lot more needs to change, like the way we measure things, the way we visualize things. Imagine one day maybe AI paired with a better way of visualizing a drug's impact on the human body. But we're just not there. And so AI is like churning up drug candidates. But guess what? We still got to run it through these very slow clinical trials. And so we just don't know. And if there will be an improvement, it will take years to find out.
15:50Telis Demos: You said before that investors were looking for, you know, kind of not AI to invest in, maybe to diversify their portfolios. Is the fact that AI is not going to like overnight sort of revolutionize drug development, is that maybe a feature rather than a bug for some investors? I don't know if I would call it a feature. I think it's more because healthcare became perceived as like a defensive trade, you know, because it just hadn't run up. Like the valuations were just like grounded, you know what I mean? And so they were just like, well, this is an opportunity for us to just park our money if AI.
16:24That's what I would say there.
16:25Telis Demos: It's weird, though, to think of a sector like pharma or biotech as defensive because, like you said, we're always pushing out the boundaries of what is possible and known and new treatments. And there is certainly a lot of risk that something that we thought was going to be promising isn't. isn't. So should an investor really think of biotech as they kind of set it and forget it part of their portfolio? No. And I should clarify, like, so the AI versus healthcare is more of like the big large cap companies, for sure. You're absolutely right. Because those companies are steadier, right? For the most part?
17:00Telis Demos: Is that the case? They're steadier, exactly. Like your Pfizer's, your Merck's, et cetera, that type of thing? Yeah. And health insurers and hospitals, you know, these are seen as non-discretionary you know, spending. And so investors rotate to that in a crisis, right? Biotech is more of like a speculative investment. And that's run up now, as we talked about, partly because it was catching up from the declines that it had actually before RFK Jr. and Trump. You know, it all started around the pandemic because the pandemic sort of sent stocks shooting up because it was like, we're going to find a cure for everything now.
17:36And then Yeah. Interest rates shot up and remember what happened. And then everything went down and biotech plunged and biotech went into a deep crisis. So we're really still crawling back from then. Exactly. And if you look at the absolute value of the XVI index that we've talked about, it's just caught up with its high from 22. So a lot of investors like that because it's like at least, you know, hey, this is I mean, you know, it's like it's like we talked about with the Moderna thing, you know, hey, we're just catching up to where we were before. Of course, that doesn't prove that something's cheap.
18:05It doesn't mean that it was ever actually worth that much. Exactly. Exactly. But, you know, biotech, I think the thing for investors to keep in mind is, like, if you want to think about whether biotech is going to keep working, as long as the M &A boom, meaning pharma companies keep buying biotech companies, and this year we're on pace for one of the best years ever, you're just going to keep seeing the sector work. And Eli Lilly has been one of the main acquirers. Yeah. So I wanted to ask about that because it seems like the, you know, the mega cash cow in the room, the GLP-1s, is what's really driving a lot of the M &A.
18:43How much of that is actually priced into Eli Lilly's stock? Or is there like, are there a lot more people who are going to, you know, still adopt GLP-1s? Is that saturated? Is everyone who's on one of these going to, you know, on one by now? It's really mind-blowing because, and Telus brought up Novo Nordis earlier, and it's like if you look at Novo Nordis stock, I think it's about where it was before Wigobi came to the market, right? Wow. And when people think of – Wow, so it's gotten no benefit from that. It went up and down. And when people think of GLP-1s, correct me if I'm wrong, the average person thinks Ozempic and Wigobi, right?
19:22They don't think Mount Jaro and Zepbound. Well, that's obviously shifting. Yeah, whichever one Serena Williams represents. Based on the sports I watch, they're trying to make you hear about Monjaro. Right, right, right. But Ozempic became just like kind of, you know, you Google something and you Uber somewhere. Yeah. You have Ozempic face. Ozempic became the word. Right. Totally. Yeah. Nobody's name dropping Monjaro.
19:45Telis Demos: Can you take us quickly through like why did Novo, why did the stock go down? Yeah. And it will answer Miriam's question from earlier because I think what happened was, And we see this a lot in biotech and pharma. And you alluded to this earlier, right? Sometimes you see companies go up and then they go back down. Because sometimes you're the first to something. You introduce a revolutionary idea. Your drug takes off. But then a company comes right after you, and it just has a better technology. It has a slightly better drug. Like Ask Jeeves in Google or something like that. Yeah, exactly. Exactly, yeah.
20:20And to be fair, Novo Nordisk and Eli Lilly were competitors in the insulin space for over 100 years or something like that. So they both discovered together that these drugs worked in diabetes. And then they both realized that this could be a powerful drug in weight loss. So they were racing together. And then Eli Lilly came up with this combination that just worked more powerfully. And that's what we see with Monjaro and ZepBat. And so Eli Lilly has just been eating Novo Nordisk's lunch. Interesting. Wow.
20:52Telis Demos: All right. Hold that thought. We're going to take a quick break. When we come back, more with David Wehner.
21:07Telis Demos: Welcome back. So it seems like this is a place where, like, index investing is really the way to go. rather than trying to pick out kind of a winner that sort of – which has worked really well in AI, right? Like the big have been rewarded. The big keep getting bigger. But in biotech investing, is the smart thing to do to just spread your bets by buying the index, especially when you're talking about the smaller caps, right? Like some small company that hasn't come out with their breakthrough yet but might. Or are people really – have people focused in on what the next Moderna is going to be? Is it already kind of known in the market what that's going to be?
21:44Telis Demos: Is Revolution going to suck all the money out of the room and everyone's just going to buy that and the others are going to kind of lose value? Yeah. That's a good question. No, I do think what Telus was saying earlier makes a lot of sense. Of course, there are companies that I think are interesting. But I think, you know, look at hedge funds, look at the way biotech, seasoned biotech investors invest, and they spread their bets. And so for someone sitting at home wants to invest in biotech, I do think like the XBI index we talked about and other ETFs that follow biotech can be a pretty good way to invest in this industry that, you know, is kind of a, you know, it's an innovative play.
22:23And it's also it's not priced as richly as some other sectors. And it's totally separate from the AI investment for now. So, yeah, that's how I think I would be doing it. And then, you know, one could also invest in big pharma companies that that are just growing more quickly, like we talked about Eli Lilly or the index as well. That's how I would do it. I wanted to ask about a kind of looming giant that we haven't discussed, and that is China. You've written about this, that China, you know, as much as these, you know, discoveries that we've had, these great breakthroughs that we've had have powered the stocks and excited investors.
23:08China could kind of threaten to undo it all because China's really very fast moving in its drug development. Is that right? Yeah. And you know what? When I spoke with investors, when I speak with investors about the different drivers of this sector, for example, AI, of course, AI is huge. But China is absolutely the thing that everyone is looking at and worrying about and the immediate catalyst or threat. There's different ways to think about it because basically China, as we've seen with other areas, they're just moving fast. They're catching up. They probably don't have the same lengthy trial requirements that we have.
23:45Exactly. They're much, much quicker trials. And people also, you know, to be just fully fair, you know, like people just work a lot more there. And so China is moving ahead. And that's already starting to threaten early stage biotech companies because they have these things called fast followers where, you know, if a biotech company comes up with an idea and they file a patent within, you know, a very quick, short amount of time, a Chinese company might have a similar drug, which is perfectly legal because that's how biotech works. you just have to come up with a different approach. Like a slight tweak to that patented drug.
24:21Yeah. So just to answer your question, I think the U.S. biotech pharma world is at a key crossroads because if it can respond to China and adapt its clinical trials and make things work more expediently, then it might be able to compete better with China. There's others who say we should shut off China completely, bar investments to China, bar everything with China, just like we've seen in other parts of our economy. So it's a big moment. It might be hard to tell that to the cancer patients who are awaiting their treatment. That's exactly the debate.
24:56Telis Demos: Has there been a deep seek moment in the market, like the way that the sudden emergence of a Chinese AI model that was maybe as good as the ones you know, caused the market to crash? Has that happened in pharma? It definitely has. In In fact, I used that term at one point because the best-selling drug in pharma right now is a drug called Keytruda. It's a cancer drug. It sells over$30 billion a year and just works on a lot of different cancers, some better than others. I've definitely seen ads for that, and now I know what it is. Yeah, exactly. And so we saw data that came out from this company that partnered with a Chinese biotech that basically showed better improvement to cancer patients using the formulation that Keytruda had, but locking it in with a new target.
25:48And suddenly the market was like, oh, boy, like, we have a problem, you know, or we have an opportunity, depending on how you look at it. Right, right, right. But stocks fell. Well, the stocks that were developing it rose. And, you know, in the case of Keytruda, Merck is the company that developed it. They fell in response to it. But not as much because they're a big pharma company. Right. As we've talked about, they've done all these acquisitions of smaller companies.
26:14Telis Demos: Yes. Well, what played out? Did it turn out that they had cracked the code and that, you know, a better version of Keytruda was coming? It's still playing out. But as the data started to come out, the debate intensified and the stock kind of came down, the company that developed it. We're still waiting for the critical thing, which is overall survival. Did patients live longer? We're waiting for more data. And also the trials were run in China. So there's a whole lot of debate about, like, what happens when you replicate that clinical trial in the United States or internationally. So, David, as we close out here, are there any favorite stocks that you want to talk about?
26:51Things that you think have a lot of potential that are maybe not quite overvalued yet in this rally? So like I said, I think investors should really try to pick either large cap companies or trade the index unless they have really high conviction about something. They really understand something very well. Maybe I can mention something that's interesting, a big moment that I think is going to happen, and we'll speak to a lot of what's been going on. And that's a company called Unicure. Unicure has a therapy that is injected right into our brain, and it's a gene therapy. And it's for Huntington's disease, where there's really nothing out there.
27:32Wow. And that's a very serious condition. So these kind of drugs, in recent memory, they've been approved by the FDA through something called the accelerated approval pathway. And so this accelerated approval pathway allowed companies to file with incomplete data, so to speak, without the normal kind of phase three comparative trials that compare one, you know, drugged arm versus a placebo arm. You know, it's just like they're taking data from a handful of patients and comparing it to sort of patients outside who aren't taking the drug. And so this company tried to file for approval for this drug based on, you know, mixed data.
28:21You know, it's hard to sort of judge completely whether these drugs work or not. But the FDA was being run by a group of people, as we spoke about, who were quite anti-pharma or at least very skeptical of the way things were being done. And the FDA said, no, you've got to go and you've got to run a complete trial. You've got to have a sham trial where you inject some people with, like, not the drug. Like a placebo. Yeah, placebo. But, like, can you inject a placebo into someone's brain? That was the huge controversy, right? Yeah. Because a lot of people were like, this is unethical. We're talking about Huntington's patients.
29:00And so it just highlighted this very interesting debate that's going on about how much do we have to hold these biotech companies to account? How much do we want them to prove that this drug works before we allow desperate patients to get access to the drug? So anyway, that whole FDA leadership is now gone. We're talking about Marty Macri, Vinay Prasad. These were people who were quite controversial. They're all gone. And now there's like a new caterer of leaders that are considered more amenable. And we're going to be seeing four-year data on this drug, this gene therapy from Unicure. And the market's going to trade very heavily on that drug.
29:45When that gets released. Yeah, the stock will react to it. Interesting. So we should be seeing that any time now? Yeah, sometime this month. And then the company is going to once again, you know, file with the FDA. So these are the kind of opportunities you have. Good luck trading on that. Right.
30:02Telis Demos: That's what I was going to say. Boy, that really highlights sort of the promise and peril of this stuff, right? It does, yeah. Maybe that data comes in and it's great and it ushers in a new era of rare disease treatment, but maybe it just doesn't work as well. And who can trade on that? But I really look forward now that I know about this to seeing what happens. For sure. We'll talk about that on this show when we can. We certainly will. Well, David, this has been a fascinating conversation. Thanks so much for joining us. It's been a pleasure. Thanks for having me. And that's everything you need to know to take on your week.
30:35Telis Demos: This show is produced by Alexis Moore and Michael LaValle. Michael LaValle is our sound designer. He also wrote our theme music. Aisha Al-Muslim is our development producer. Chris Zinsley is our deputy editor. and Leetal Molad is our senior director of shows. For even more, head to WSJ.com. I'm Tel Stimos. And I'm Miriam Gottfried. Until next time. What if you invented like a box, like a small box where just a tiny drop of blood would... Seems like we really could use them for this. It's a good idea. A Theranos reference here. It's a great reference. Oh, kidding aside, that actually would be a great invention.
31:13Telis Demos: It would be great if it worked. In that case, it happened to not work.
31:45Telis Demos: GlobalX ETFs.com. GlobalX, beyond ordinary ETFs.
Despite a rough past week for the healthcare sector, pharmaceuticals and biotech stocks have outperformed the S&P 500 this year. Investors have gotten excited over cancer treatment breakthroughs for Moderna, Merck and Revolution Medicines—plus regulatory shakeups at the FDA. But is market hype running ahead of reality? Can the rally last?
On this week’s episode, co-hosts Telis Demos and Miriam Gottfried are joined by WSJ’s Heard on the Street columnist David Wainer to discuss how AI and competition from China are shifting the market, where pharma M&A is headed next, and how everyday investors should navigate the sector.
This is WSJ’s Take On the Week where co-hosts Telis Demos, writer for WSJ’s Heard on the Street, and Miriam Gottfried, WSJ’s investing and wealth management reporter, cut through the noise and dive into markets, the economy and finance—the big trades, key players and business news ahead.
Have an idea for a future guest or episode? How can we better help you take on the week? We’d love to hear from you. Email the show at [email protected].
To watch the video version of this episode, visit our WSJ Podcasts YouTube channel or the video page of WSJ.com
Further Reading
Exclusive | Cheap Biologic Drug Alternatives Stall, Threatening U.S. Healthcare Savings
Hype for Moderna’s Cancer Vaccine Is Running Ahead of the Math
China is a Threat to Biotech’s Massive Bull Run
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