Nov 6, 2026 · 1h 0m
Election stakes meet biotech’s regulatory and pipeline risks
Episode 202 - November 6, 2026
The episode connects a new political landscape to FDA stability, drug pricing, clinical safety, and the evidence shaping biotech valuations.
- 1A Democratic sweep could reshape healthcare policy, but regulatory continuity and macroeconomic uncertainty remain the nearer-term questions.
- 2Pipeline news spans strong oncology demand, safety concerns, failed cardiovascular development, and sharper scrutiny of gene and cell therapies.
- 3Upcoming data in immunology, obesity, hematology, and CAR-T could determine whether recent biotech optimism survives tougher evidence.
Don't miss
The panel weighs whether reports surrounding Vykat reflect a drug-related safety signal or the difficult comorbidities of Prader-Willi syndrome.
The brief
Brian Skorney, Paul Matteis, Yaron, and guest Adam Feuerstein examine how a Democratic sweep could affect drug pricing, the FDA, healthcare spending, interest rates, and biotech sentiment.
The panel sees room for modestly positive outcomes but warns that FDA credibility, macroeconomic conditions, and political volatility could matter more than headline policy changes.
Vertex’s povetacicept and Revolution Medicines’ launch illustrate biotech’s upside, while Vykat, resmetirom, Zolgensma, and pelacarsen expose the sector’s safety and evidence risks.
The psilocybin discussion turns on whether Usona’s filing can challenge COMPASS, and whether regulated products can sustain a market beside widely available recreational alternatives.
The episode closes with cardiovascular failures, BeiGene’s pipeline timing, and ASH data suggesting CAR-T’s future depends on balancing efficacy with toxicity and durability.
What was said on this episode
39 statements · 19 positive · 16 negative · 2 mixed · 2 neutral
Interest rates materially affect biotech cost of capital and investment flows.
“Interest rates, both in terms of Fed fund rates and real interest rates, all have major effects on cost of capital, leading to big shifts in broad-based investing.”
Listen at 2:19
The FDA should restore credibility, standards, and consistency.
“I want the FDA to get back to a point, right, where we kind of like... look up to the FDA and the standard and the consistency.”
Listen at 6:40
Drug pricing is a likely area of political compromise and sector risk.
“it feels like drug pricing could be a logical area of compromise. So I think that to me is like the biggest risk.”
Listen at 7:29
Healthcare stocks face greater downside risk over the next year.
“for stocks, there's probably more downside risk to just this kind of stuff in the next. year”
Listen at 7:52
The new government may produce headlines without materially changing policy outcomes.
“at the end of the day it won't really matter”
Listen at 9:07
The U.S. government will remain gridlocked for two years.
“we're going to be pretty clearly in the gridlock for the next two years”
Listen at 9:12
Biotech is unlikely to remain immune if broader markets come under pressure.
“if the market's going to be under pressure it's hard to see how biotech is immune”
Listen at 9:52
A slower rate increase could make biotech more resilient.
“the bull case in biotech is that rates are going to go up with a slower slope now and so we're going to be more immune”
Listen at 10:33
Heidi Overton will probably not be nominated to lead the FDA.
“if you put me, if you, like, said I had to give you a prediction, I would say no.”
Listen at 11:28
The FDA currently appears more stable under Kyle Diamantis.
“the FDA feels much more stable right now under him”
Listen at 12:01
The new government will be modestly positive for biotech.
“I think it's a net positive.”
Listen at 15:17
Vertex’s povetacicept will likely receive approval.
“I think there's very little doubt. that this drug is going to get approved.”
Listen at 16:56
Vertex has declined to disclose treatment interruptions in its study.
“Vertex has not provided that answer. They've declined. to provide an answer.”
Listen at 18:35
Vertex’s phase three study showed equal infection risk between treatment and control.
“the infection risk was equal, same between the drug arm and the control arm.”
Listen at 18:51
An IgG-monitoring label would disadvantage Vertex against competing drugs.
“that would put them at a competitive disadvantage.”
Listen at 19:21
B-cell-modulating drugs provide benefits that outweigh their infection risks.
“these drugs are great. It's more than worth the risk.”
Listen at 23:05
Selective Gd-IgA1 targeting could avoid infection and IgG-reduction risks.
“If you can just target GDIGA1, you're not going to have any of these infectious risks.”
Listen at 23:38
Vertex will launch its IgA nephropathy drug third.
“Vertex is going to be third to launch.”
Listen at 23:58
Revolution Medicines generated $198 million in its first five weeks of sales.
“$198 million in five weeks, again, blew the doors off pretty much every expectation.”
Listen at 28:59
Revolution Medicines’ launch may rank among the strongest oncology launches ever.
“what looks like might be probably one of the strongest, if not one of the strongest oncology drug launches of all time.”
Listen at 29:10
Revolution Medicines must execute nearly perfectly to justify its valuation.
“execution has to be perfect.”
Listen at 31:15
FDA safety reports describe eight deaths and over 100 hospitalizations among Vykat users.
“there have been now eight deaths. of patients who have been described by CAT. There have been well over 100 patients who have been hospitalized.”
Listen at 31:58
Vykat was approved after an unsuccessful primary analysis using a randomized-withdrawal study.
“it was sort of a... approved on a randomized withdrawal study after, you know, the sort of primary analysis was not successful.”
Listen at 33:50
Any cash flow from Neurocrine’s Vykat deal could benefit its stock.
“are they going to generate any sort of cashflow from the deal would, would maybe be a positive for the stock.”
Listen at 35:17
Vykat may pose substantially higher risks for a definable patient subgroup.
“you might be able to tease out a population of patients where this is just much higher.”
Listen at 36:35
Resmetirom is probably not hepatotoxic based on its broad use.
“it's probably not liver toxic given the number of patients who have had it”
Listen at 42:02
A low-priced Usona product could undermine Compass’s business model.
“if they set price really low, you know, does that essentially undermine the Compass business model?”
Listen at 44:37
Patients with serious diseases tend to prefer standardized products administered by healthcare professionals.
“when push comes to shove when you have a serious disease like people tend to want the product that they can kind of rely on knowing exactly what it is and that it's given by a healthcare professional.”
Listen at 47:41
Zolgensma’s risk-benefit profile remains favorable in severe SMA.
“the risk benefit I would say is still favorable.”
Listen at 50:24
AAV gene therapy currently appears best suited to rare diseases.
“AAV right now feels like it's a rare disease modality”
Listen at 51:17
Ionis and Novartis’s pelacarsen program is unlikely to advance after failure.
“That drug has now failed. So it's very unlikely that it's going to go anywhere else.”
Listen at 52:59
Lp(a) may be a weaker disease driver when other risk factors are controlled.
“it's probably much less of a driver when patients are otherwise very well controlled.”
Listen at 54:05
Amgen’s phase three Sjögren’s trial produced very strong results.
“Amgen sort of hit it out of the ballpark in the phase three”
Listen at 55:00
Amgen will probably file its obesity pen application in the second half of next year if successful.
“they're probably going to be filing assuming success in the second half of next year with the pen.”
Listen at 55:58
BeiGene’s BTK degrader will likely show superiority in its head-to-head trial.
“they absolutely believe, and we actually agree, that they'll be able to show superiority head-to-head.”
Listen at 57:23
Gilead’s anito-cel is expected to be less effective but safer than Legend’s product.
“I think it's expected that the Gilead product won't be quite as effective, but a lot safer.”
Listen at 58:46
Legend reduced Parkinsonian risk from roughly 4–6% to 1.25%.
“reduce the Parkinsonian risk to, you know, from 4%, sort of, you know, 4, 5, 6% to 1.25.”
Listen at 58:59
In vivo CAR-T showed approximately 100% response rates durable through five months.
“everybody is essentially at 100% response rate and fairly durable up to five months.”
Listen at 59:21
In vivo CAR-T appears promising based on early data.
“it looks like in vivo car t is is fairly promising”
Listen at 59:42
Statements are attributed to the speaker as said on the episode and reflect their view at the time, not PodLume's. They are not advice.
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