Definium's new psychedelics data, and a reprieve for international scientists

0:05Jonathan Wosen: Welcome to this week's episode of The Read Out Loud, a weekly biotech podcast from STAT. I'm Allison DeAngelis. I'm Adam Feuerstein. And I'm Elaine Chen.

0:18Jonathan Wosen: International scientists who study and work in the U.S. got a reprieve this week. A judge put a temporary hold on a rule that would severely limit their time here, but many are deciding to go elsewhere to do their research. All the routes are closing. All the options are no longer viable. And I think that we in science feel this. And I have people in my lab that are also international and they're really feeling it.

0:41Fanta Aw: So I think I'm going to leave the U.S. There are countries that have very clearly said to international scientists, we're open for business. We're happy to recruit you. We're happy to provide an environment that is more conducive to your research. we welcome you here because we see the benefits that you bring to society.

1:01Jonathan Wosen: What does the administration's ongoing efforts to curb immigration mean for the future of these international scientists and for American medical research? That story and the latest biotech news, including a Novo Nordisk rebrand, a rare disease drug approval, and another positive psychedelic treatment study coming up. But first, a word from our sponsor.

1:49Jonathan Wosen: Thank you.

1:55Jonathan Wosen: from someone who's been covering biotech for more than 20 years. If you want to keep up and stay sharp, subscribe to Biotech Scorecard. Only for Stat Plus subscribers.

2:10Jonathan Wosen: Okay, guys, I'm saying something I never thought in my life, I would say, but I'm excited that football season is starting. Let's go, Elaine! Elaine, are you feeling okay? Are you taking psychedelics? What's going on here? There could be something severely wrong with me, but I think that's what just happens when your team is doing amazing. So your team is the Chicago Bears? Yeah. They scored 56 points in their first game. 59 points. Sorry, 59 points. And you're excited. My team, the Patriots, lost. Yes. I will predict that we will still be a better team than your team at the end of the season.

2:46Jonathan Wosen: Your quarterback is terrible. Wow. I love setting up a competition early in the season. It's going to be a real good fall, guys. Okay, Elaine, on biotech news, can you start off? We have had so much to talk about in the psychedelics field. Can you start off telling us a little bit more about the big clinical trial readout that we got this week? So this week, Diffinium Therapeutics said that its LSD therapy helped relieve patients' anxiety in a second phase three trial. So that sets the company up to be able to file for approval with the FDA. Notably, most other psychedelic biotechs are developing drugs for depression or PTSD.

3:27Jonathan Wosen: Daphneum is unique in that it is seeking approval for this drug for anxiety. And if approved, it would be the first psychedelic drug approved for anxiety. So, Elaine, I feel like we're really entering this explosive era of growth for psychedelics. You know, for a long time, psychedelic-based therapies were very outside the mainstream. but we've had now a succession of positive clinical trials. So what does this all mean for the field, do you think? I think we're definitely seeing a lot of momentum in the field. I think part of it is that the Trump administration has shown a lot of interest and support for the field.

4:04Jonathan Wosen: I think we've all seen how successful J &J's ketamine therapy has been. Demand has really taken off more recently for the ketamine therapy, And I think that's an indicator we could see big demand for psychedelics. I mean, the issue with the current psychiatric antidepressant medicines that we have is that they take weeks to have an effect. A lot of people don't respond to them. And so the hope with psychedelics is that these are therapies that can potentially help patients very quickly. Of course, there are going to be a lot of real-world challenges if slash one these drugs are approved because patients have to go into these specialized clinics to get the therapies.

4:47Jonathan Wosen: They have to be monitored by clinicians. Like for LSD, it could be up to 8, 10 hours. So that's a really big time commitment. And you have to set up these clinics. It's probably going to be expensive. So there are a lot of hurdles that we have to work through as these drugs take off. This is really interesting because, as you point out, Elaine, we have had this precedent that's been set by Johnson & Johnson's ketamine drug. There's a little bit of quibbling in the industry that's considered by a lot of people to not be a true psychedelic. So what is on the horizon is really some of the first true psychedelics, one could argue.

5:25Jonathan Wosen: Right, Elaine? Yeah, I guess if you think about psychedelics in a traditional sense, we haven't yet had any real psychedelic drugs formally approved by the FDA. What's coming could be the first psychedelics approved. Probably what would be coming first would be Compass Therapeutics treatment, psilocybin. That could happen at the beginning of next year. Do you think that we'll see a delineation or a division, Elaine, between some of the psychedelics that are not only fast acting, but are administered really quickly and don't require all this monitoring versus Diffinium's therapy, which would require pretty extensive monitoring?

6:03Jonathan Wosen: Yeah, there probably will be more demand for psychedelics that have very fast effects. Most notably, the one that companies are developing is called 5-MeO-DMT. that one is much, much faster. And that's actually a therapy that Atai Beckley, one biotech has been developing and Atai was actually just recently bought by Eli Lilly. So clearly Eli Lilly sees potential in the space. Yeah, and I'll note that nothing says mainstream more than big pharma getting involved in a particular drug field. And like you said, Elaine, Eli Lilly buying Atai, we had AbbVie buying a psychedelic drug developer called Gigamesh.

6:41Jonathan Wosen: and of course, as you mentioned, J &J. So this is very much a part of Big Pharma's strategy to sort of get into this business because obviously they see this is a substantial business opportunity. Okay, Adam, I want you to turn it over to the drug approval that we got this week from ScholarRock, a first of its kind therapy. What did we see? Yeah, so the FDA last Friday approved a drug called Assembild. It's from a biotech company called ScholarRock. And this is the first ever therapy that targets the loss of muscle in patients with spinal muscular atrophy. That's a rare and progressive disease.

7:18Jonathan Wosen: It destroys nerve cells that control speaking, breathing, walking. You know, babies with the most severe form who go untreated usually die by the age of two. Now, Assembild is approved in combination with current therapies. And this new Scalarac drug helps slow the loss of that muscle function. I think the other noteworthy thing here is that this drug works by blocking the activation of myostatin. That is a protein that limits muscle growth. And there's been a lot of attention paid to this class of myostatin drugs. So Scalarock and other biotech companies are testing these myostatin-blocking drugs in obesity, for instance, with the goal of offsetting the muscle loss that's often seen in patients who take blockbuster GLP-1 drugs.

8:02Jonathan Wosen: Okay, switching over to a rebranding of Novo Nordisk. Elaine, what's going on in the marketing department of our favorite Danish pharmaceutical company? Novo Nordisk are dropping Nordisk. They're just Novo. Now they're just Novo. They're just Novo. And this is all part of a bigger marketing strategy that Novo is trying to carry out that is focused on the consumer or the customer. Even in their press release, they say customer, consumer before they say patient, which is very telling. I think it tracks with their way of commercializing obesity drugs. They've moved towards direct to consumer. They see more and more to be focusing on selling their obesity drugs as consumer products.

8:46Jonathan Wosen: And this is a notable shift because when Novo Nordisk first started selling its obesity drugs, it really focused on selling them as serious medication. Obesity is a serious medical disease. We need insurance companies to cover these medications. And this is just a completely different narrative now. Yeah, I've talked to so many people over the last year or two about how we're kind of in this era of the consumerization of drug development and developing new medicines, really specifically honing in on what consumers want. And like consumers like a little quippy name. They like Aura, Whoop, Novo.

9:27Jonathan Wosen: Novo Nordisk kind of feels in the 21st century a little lengthy and outdated. I'll add stat to that list of brand names. And stat? Short, succinct. Okay, I want to wrap it up with our other big obesity player, Eli Lilly. We sometimes call Lilly. Their CEO, Dave Ricks, just joined X slash Twitter, as I will always know it. And he has been posting, retweeting, but there's a few suspicious things. So it's a notable milestone, I guess, when you get the CEO of the world's largest healthcare company joining Elon Musk's favorite social platform. He has just under 6 ,000 followers, which not that great.

10:09Jonathan Wosen: By comparison, I'll note that Pfizer CEO Alba Borla has 4.6 million followers. So Dave's got a way to go. You know what the best way to up his social media game is? I think that he needs to follow you, me, and Elaine. I agree with you, Allison. That is very true. That's the key to social media fame. Maybe he should start commenting on Chicago Bears games. Yeah.

10:51Jonathan Wosen: On Monday, a federal judge temporarily blocked a Trump administration plan that would have placed a four-year cap on the types of visas foreign students use to study in the U.S. A more restrictive visa policy is necessary to protect national security. That's what Trump officials have argued. Outside experts, however, have warned that the rule could dramatically impact the strength of the nation's biomedical industry, given that international researchers make up a large share of the U.S. life science workforce. We are losing international students. You have to be global to be globally competitive, to have a workforce in science that's global.

11:27Jonathan Wosen: But when the U.S.

11:28Fanta Aw: is cutting itself off, the science will suffer really badly. I see all these European institutes that are attracting international scientists that have trained in the U.S. And they actually value our skills and what we provide as scientists. And I'm thinking more about that now rather than continuing my career in the U.S.

11:52Jonathan Wosen: We wanted to find out more about the changes facing these international scientists and what they may mean for biomedical research in the United States. Adam and Elaine were joined by stat reporter Jonathan Wosen, who has been covering this issue, and by Dr. Fanta Av. She's executive director of the NAFSA, the Association of International Educators. Thank you both for joining us. Thank you for having me. Thank you. Jonathan, I want to start with you. You've been following this issue for a while now. How big of a role do international students play in the biomedical research that happens in the U.S.?

12:29Jonathan Wosen: They play a pretty huge role. Before I was a journalist, I was a graduate student at Stanford working in an immunology lab. And I can tell you that I was probably one of the few U.S. citizens working in that lab. We had postdocs from India, from China. We had researchers coming in from Israel and Denmark. Our lab manager was from Brazil. I'm from San Diego, but most of the people around me were from different countries. And just to put some numbers around that, around a quarter of graduate students in the life sciences are from other countries and come here to study. When you talk about postdocs, so people who already have a PhD, it's closer to 60%.

13:10Jonathan Wosen: So these folks are a huge fraction of our scientific workforce, especially in biology. And Jonathan, tell us briefly about this recent case and what the judge's decision means. So the case has to do with the Trump administration's efforts to put some stricter rules around how long international students and scholars can stay in the U.S. So there was a policy for about 40 plus years called duration of status, which meant that students and postdocs could stay in the U.S. for the length of their training. There wasn't a fixed endpoint. As long as they were making progress on their degree of progress in their studies, they could continue to remain in the country.

13:52Jonathan Wosen: So the Trump administration has said that system is incentivized fraud and needs to be reformed. So what they've attempted to do is to put a hard four-year cap on how long those people can stay here unless they apply and receive extensions. So the lawsuit was an effort by NAFSA, Dr. Av's group, and other organizations to stop that from taking effect. What just happened this week was that this federal judge put in place a preliminary injunction. So the rule would have took effect as of Tuesday, late Monday afternoon, the injunction came in. So the lawsuit's going to move forward. And for the moment, that change in duration of status won't be happening.

14:36Jonathan Wosen: Dr. Av, I want to turn to you. So as Jonathan just said, your organization, the Association of International Educators, is a plaintiff in the lawsuit. Can you walk us through what your organization thinks is wrong with this proposed policy by the Trump administration?

14:54Fanta Aw: So there are a couple of things wrong with the policy. As Jonathan mentioned, the duration of status has been in place for decades. And in addition to that, post 9-11, a student exchange visitor information system was created. Anything having to do with the status of the student is recorded on this system that the Department of Homeland Security has real-time access to. So we already have a system that is tracking. And so the government, they have yet to prove what is actually broken with our current system. They have yet to provide evidence that there's, quote-unquote, widespread fraud, when we've had for decades thousands and thousands of international students who come to the U.S.

15:34Fanta Aw: The rule arbitrarily sets four years. When you're looking at a PhD program, there's no PhD in the United States that is four years. This would require every single PhD student in the U.S. that is an international student to go ahead and apply for an extension. And by the way, there is no appeal to a denial of that extension. No student would be willing to take that kind of risk given the high stakes of a U.S. education.

16:00Jonathan Wosen: Dr. Arb, is there any legitimacy to the aspect of the Trump administration's argument that there is the potential for abuse here of what they call, quote, forever students, students who basically enroll in courses forever to avoid leaving the U .S.? What is wrong with a cap? Maybe four years is too short, but is a five-year cap, a six-year cap, is that something that would be okay?

16:26Fanta Aw: So here's the issue with it. You want to establish a cap when you already have a tracking system. The forever student, by the way, you have the right as a government to request and to require from a university documentation for why that student is still here. And when a student ceases to be a student, the university is required to put that onto the system so that immigration is aware of a student who has completed their studies and they have their address, they have all of that information. So that's the first thing about having a cap when you already have a system. And if the issue is fraud, let's talk about how we solve for that.

17:03Fanta Aw: Give us evidence and let's solve for that. But you don't create a whole new system on top of an existing system, which, by the way, is fully funded by international students. Because we agreed no taxpayer should be funding these systems, right? It should be paid for by the students. And then why would you set an arbitrary cap of four years when you know doctoral programs are seven years plus? at a time where the U.S. has a massive shortage of students in the STEM field for an economy that needs to grow. All you're doing is discouraging international students from coming to the U.S., and that comes at a cost to the U.S.

17:41Fanta Aw: economy, to U.S. innovation, to U.S. research infrastructure, and so forth. You do not take a sledgehammer to a problem because in this case, it is a solution in search of a problem.

17:55Jonathan Wosen: Jonathan, aside from this policy on the four-year cap, tell us about what else the Trump administration has been doing that's had an impact on these young international scientists. They've done and attempted to do a lot of different things. For one thing, there's a travel ban on about 39 countries, some fully banned from coming to the United States, some partially banned. Department of Homeland Security has also come up with this enhanced or extreme vetting of international students, which involves screening social media profiles, which people applying for visas have been asked to make public.

18:31Jonathan Wosen: And there's a lot of concern that that's essentially being used to identify whether people are critical of the government. There are students who've had visas revoked over things that seem relatively minor, like traffic citations. And there's also just been a lot of general uncertainty about what the Trump administration is going to do next. So a year ago, the president announced a plan to put in place$100 ,000 fees for H-1B visas. So that's a class of visa that people from outside the U.S. who are working here in biotech or other industries would be using. That's been blocked by the courts for now, although the administration's reintroduced that as a proposal.

19:13Jonathan Wosen: When you talk to students, they frame this duration of status issue as just the latest thing for them, the latest potential obstacle on top of a fear that they're already being targeted and that leaving the U.S. to present at a scientific conference is risky because you may not be able to come back in to return for your studies. It's created a real environment of fear and concern for students right now. And Dr. Av, what are you hearing from the students and the postdocs that you talk to about these issues? How is it impacting them?

19:48Fanta Aw: Well, we've heard from students is that the policy has in fact become uncertainty. Uncertainty has become the policy of the current administration and that they are really rattled by that. And again, given the sacrifices that one must make to become a student, both in terms of time, resources, and everything else, that they really are beginning to question about the value proposition of coming to the U.S. The U.S. has an excellent educational system, given our institutions here, and a long history of really producing graduates that have done cutting-edge work. They appreciate the research infrastructure.

20:30Fanta Aw: They appreciate the innovation, but they're questioning really whether or not is the U.S. the place for me. And clearly, many have come to the conclusion that the U.S. has become increasingly unwelcoming. And that's what we've heard from postdocs. That's what we've heard from master's students. That's what we've heard from actually prospective students who are looking to the U.S. and have decided to go elsewhere. Germany has seen a significant increase in Indian students that have opted to go to Germany. South Korea has literally surpassed their target of 300 ,000 students a year ahead of schedule for full degree programs because students are deciding on other destination.

21:13Fanta Aw: It's not that they do not care about the U.S. system and they don't believe in it. They absolutely trust the educational system, but there's a massive trust deficit with the administration and the way the administration has been acting when it comes to international students. And Jonathan outlined very well what has been the deluge of policies, executive orders that have come up. It has had consequences. Just to give you an example, we have 47 ,000 less STEM PhD students from 2025 to 2026 that have enrolled in U.S. institutions. This is coming in on the heel of other countries that are competing with us for those same talent.

21:55Fanta Aw: You name any major economy, they're competing with the United States. And right now we're losing. We're losing in that competition. Students have clearly indicated that if it came to be, they will decide to go elsewhere. Going elsewhere means not only is the U.S. losing, but it means where will the next discovery take place? Where will the next big pharmaceutical discovery, biomedical discovery, AI discovery take place? Given where we are right now, unlikely that it'll be the U.S. if we continue down this road.

22:28Jonathan Wosen: And Jonathan, you have some recent data showing a large decline of international students who want to come and study here, right? Yeah, there are a couple different data points. One thing that I had started to pull together recently was from a website called Study Portals. It's a website that a lot of students use to look up information on different academic programs. It was a popular one-stop shop. So I asked them for some data on changes in international students looking at U.S. PhD programs in the life sciences. If you look at page views as an indirect sign of student interest, that's gone down by about 40-something percent across the board over the past year or so.

23:13Jonathan Wosen: That varies a bit by country to country. You wouldn't be surprised to hear that page visits from people in Iran have dropped off by over 85 % or so. In other places, it's closer to 40 or 50. But that, I think, aligns with other data points we're seeing that the US is becoming a less attractive destination for the next generation of scientists. And also, ultimately, many of those folks will want to work in biotech. The people who are working in labs at Harvard or MIT, eventually many of them will look to work in industry. So this is relevant in the long term for the biopharma industry as well. I just wanted to also add that in addition, while that's going on here,

23:59Fanta Aw: other countries are watching very carefully and they see this as opportunistic. So countries like Canada and others are making significant investment in attracting some of our best scientists, right? They're willing to invest in creating laboratory, making sure that there is a connection between universities and companies and so forth. And it's not just Canada. Europe has indicated they're open for business. And they've been very clear about wanting to attract scientists to Europe that are currently in the United States. So this is really a race for talent. And as a race for talent is a race for innovation.

24:39Fanta Aw: And as Jonathan laid out, there are many stakeholders in this, universities, certainly students themselves, but also companies. One in four unicorns that were created in this country were created by former international students, and they employ people for jobs in the United States. They create incentives for the economy. It is also the case that for every one of those individuals who are involved in research, they're bringing in American citizens as researchers because the research, it's a team effort. And so they are bringing in U.S. citizens into the research infrastructure and the research ecosystem.

25:16Fanta Aw: This is what would be lost if we continue down the track that we're on and we're already seeing the signs. And it's going to be very difficult to bounce back from this. This is not a matter of switching it on and switching it off. Once you've lost the trust, it is hard to reestablish that trust. So, Dr.

25:35Jonathan Wosen: Av, the judge issued a preliminary injunction in this case. What's next for this lawsuit and what do you expect to happen with the administration's continuing efforts to limit international scientists and researchers?

25:49Fanta Aw: So the lawsuit involved two parts, right? The preliminary injunction, and we got the relief yesterday for the rule to not be implemented because the rule would have actually been in effect today. So that's the first part. We knew the urgency of the matter and needed to get in front of the judge. And we saw the 48-page decision from the judge. Second is we filed a lawsuit. And the lawsuit lays out what we feel is wrong with this duration of status rule. And so we're going to continue to pursue that with the government. We expect the government to appeal the preliminary injunction. And we're going to go all the way as far as the complaint itself is concerned.

26:26Fanta Aw: So to answer your question, we're in this for the long haul. What is at stake is very high. What is at stake is not just a short-term issue. It has long-term implication for a nation that has been the brain trust from the rest of the world. And we want to see the U.S. continue to thrive. We want to see U.S. research continues to be preeminent in all the ways. There's room for everybody. Every other nation can certainly do cutting-edge research. But it would be very unfortunate that the U.S. loses out because of ill-advised, ill-informed policies.

27:03Dr.

27:04Jonathan Wosen: Fato Av is CEO of NAFSA Association of International Educators, and Jonathan Wozen is a stat reporter and a colleague of ours. Jonathan, Dr. Av, thanks both of you for joining us.

27:16Fanta Aw: Thank you for having us.

27:17Jonathan Wosen: Thanks for having me.

27:22Jonathan Wosen: That does it for another episode of The Read Out Loud. Our podcast is produced by Rachel Gottbaum. Our senior producer is Alyssa Ambrose. Our executive producer is Rick Burke. And our theme music is by Brian Joel. We'd love to hear from you. Tell us what you like about this week's episode, what you didn't like, and tell Elaine why the Chicago Bears are a terrible football team. You can do all that by sending us an email at readoutloud at statnews.com. And if you like what we do, leave a review or rating on Apple Podcasts or wherever you get your podcasts. See you next week. you