Oct 13, 2026 · 25 min
Biotech markets cool as trial failures test the sector
Ep. 392 - Biotech markets: Pause before the storm?
The episode connects softer public markets, harder financing conditions, cardiovascular trial design, and a consequential challenge to CMS pricing policy.
- 1Biotech’s M&A-fueled first half gave way to a weaker third quarter marked by volatility, short squeezes, and clinical setbacks.
- 2PIPE financings and reverse mergers gained traction as biotech IPOs faced a more uncertain market for new listings.
- 3Cardiovascular failures highlighted the need for better biomarkers, patient enrichment, and trial designs focused on higher-risk populations.
Don't miss
Selina Koch’s discussion of three late-stage cardiovascular failures shows why genetic validation alone may not translate into treatments for age-related disease.
The brief
Steve Hansen and the BioCentury team examine how biotech moved from an M&A-driven first half into a weaker third quarter, with volatility, short squeezes, and clinical setbacks reshaping the market.
PIPE financings tied to reverse mergers stood out as traditional IPOs struggled to establish momentum, raising questions about how biotech companies will access public capital next.
Selina Koch reviews three late-stage cardiovascular failures and the limits of translating genetic targets into treatments for age-related disease without stronger biology and biomarkers.
The conversation argues that secondary-prevention trials may need higher-risk patient populations and better enrichment strategies, including in NewAmsterdam Pharma’s CETP inhibitor study.
Steve Usdin turns to PhRMA’s challenge to CMS’s GLOBE international reference-pricing model, including the possibility of an injunction and consequences for future policy.
What was said on this episode
16 statements · 4 positive · 7 negative · 3 mixed · 2 neutral
Large public therapeutics acquisitions have paused since mid-July.
“the last really big public therapeutics company acquisition was mid-July. It's been almost three months since then.”
Listen at 2:02
Moderna reported positive Phase 3 adjuvant melanoma cancer data.
“the Moderna positive phase three cancer data in adjuvant melanoma”
Listen at 3:07
Biotech activity will remain quiet in Q4 before recovering early next year.
“the thought is that it's going to be a pretty quiet fourth quarter as well and then hopefully things will pick up again at the start of the year”
Listen at 5:43
IPO-capable biotech companies are increasingly choosing reverse mergers with large PIPE financings.
“We're seeing companies that easily could have done a traditional IPO, take the reverse merger route and raise really big pipes to go along with that.”
Listen at 7:09
The biotech reverse-merger and PIPE trend will continue into Q4.
“I think there's every expectation that that will continue forward for sure into the fourth quarter.”
Listen at 7:21
Higher bond yields pressure biotech valuations, financial models, and cost of capital.
“that can mess with valuations. It messes with models, but, you know, cost of capital.”
Listen at 8:05
Recent weak IPO performance may cause prospective biotech issuers to delay listings.
“the performance by those last two might give people pause”
Listen at 10:03
Three late-stage cardiovascular failures involved genetically supported targets in age-related diseases.
“all three involve targets ahead. very strong, compelling human genetic support. And all three involved age-related diseases.”
Listen at 12:13
Inherited genetic variants establish lifetime pathway importance but do not directly predict drug effects.
“that variant can certainly tell you that that pathway is important and that it has effects over a lifetime. But a drug development... program answers a very more, like a more specific question.”
Listen at 12:36
Primary prevention would have the greatest impact, but will not arrive soon.
“Ultimately, you need to get to primary prevention. That's where these kinds of diseases are going to be impacted the most. But that's not going to happen in the near future.”
Listen at 15:34
NewAmsterdam Pharma will begin its CETP trial interim analysis in early December.
“They're going to start their interim analysis soon, like beginning of December.”
Listen at 17:35
Any efficacy signal could preserve LP(a) as a therapeutic target.
“if there's any hint of... of efficacy, then that could keep LP alive.”
Listen at 17:54
Pharma sued to block CMS’s GLOBE Medicare pricing model.
“Pharma sued in the federal court in DC on October 7 to block GLOBE.”
Listen at 18:56
The current Pharma lawsuit challenges GLOBE on statutory authorization rather than procedure.
“The suit is a little bit different from a prior lawsuit that was filed against a similar attempt to use international reference pricing in Medicare.”
Listen at 19:05
GLOBE and GARD will likely be invalidated by courts.
“my bet is that Globe and Guard are going to be knocked out by the courts.”
Listen at 23:10
A Pharma victory could remove an administration tool for coercing voluntary MFN agreements.
“if pharma prevails, depending on how the court rules, it could take away a stick that this administration has used to compel or to coerce companies into doing MFN deals.”
Listen at 23:37
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.