Upfront Briefing
The big policy headline: federal health officials revised the childhood vaccination recommendations, reducing the number of recommended vaccines (a meaningful demand-signal shift for pediatric franchises).
In regulatory land, the FDA detailed its rejection of Sanofi’s investigational multiple sclerosis drug, citing severe liver injury risk and unclear benefit.
And the drug-pricing grind continues: HHS urged the Supreme Court to decline AstraZeneca’s petition over Medicare price negotiations.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,902.0 |
0.6% |
0.8% |
| Nasdaq 100 |
25,401.3 |
0.8% |
0.6% |
| Russell 2000 |
2,547.9 |
1.6% |
2.7% |
| XBI (Biotech ETF) |
120.2 |
(1.1%) |
(1.5%) |
| Nasdaq Biotech |
5,639.7 |
(1.2%) |
(1.2%) |
| Clinical Trials ETF (BBC) |
36.8 |
(2.3%) |
(4.7%) |
|
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Risk was on, biotech wasn’t: Russell 2000 1.6% vs XBI (1.1%).
- BBC was the standout mover to the downside, sliding (2.3%) on the day.
- Market data: U.S. close Mon 05-Jan-2026.
The Big 3
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1
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US overhauls childhood vaccination recommendations
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Federal health officials have revised the childhood schedule, reducing the number of vaccines recommended for all children (shifting several to high-risk / shared decision-making).
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Why it matters:
Shifts several shots from ‘routine’ to risk-based/shared decision-making, which can pressure predictability of pediatric volumes and raise policy discount rates across vaccine franchises.
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Source:
STAT
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More:
Endpoints; Fierce Pharma
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2
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FDA details rejection of Sanofi's investigational MS drug
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The FDA has released details regarding its rejection of Sanofi's investigational multiple sclerosis drug (tolebrutinib, a BTK inhibitor), citing severe liver injury risk and unclear benefit.
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Why it matters:
The CRL reads as a class-level safety bar for systemic MS BTK inhibition; timelines and trial designs may need to change (monitoring, endpoints, dose, or risk mitigation).
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Source:
Fierce Biotech
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More:
Endpoints
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3
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HHS asks Supreme Court to decline AstraZeneca petition
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HHS/DOJ urged the Supreme Court to deny AstraZeneca’s bid to revive its challenge to the Medicare drug price negotiation program (keeping IRA pricing litigation pressure in place).
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Why it matters:
A denied petition keeps IRA negotiation litigation stuck at the lower-court status quo, sustaining the pricing overhang for negotiation-exposed brands and their long-duration DCFs.
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Source:
Endpoints
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Everything Else that broke
- Appeals court blocks NIH indirect cost cap plan. — Endpoints
- Crinetics reports first full-quarter sales for Palsonify. — Endpoints
- Leqembi subcutaneous formulation BLA accepted in China. — PR
- Galapagos initiates wind-down of cell therapy activities. — PR
- Idorsia starts Phase 2 trial for CCR6 antagonist in psoriasis. — PR
- Hummingbird Bioscience doses first patient in Phase 1 trial. — PR
- AI-designed antibodies and biopharma timelines. — STAT
- Drug pricing remains a 2026 overhang despite MFN deals. — BioSpace
- FDA held fewer advisory committees, diverged more in 2025. — BioSpace
Deal Flow
M&A / BD&L
- Cyclerion announces strategic agreement with Medsteer. — PR
VC / Private Financings
- No notable VC / Private Financings
IPOs / Follow-Ons
- Biotech IPO market slowed sharply in 2025. — BioSpace
Academic Corner
- Prime editing to suppress nonsense mutations. — Nature RDD
- CRISPR–Cas3-based editing for targeted deletions in a mouse model of transthyretin amyloidosis. — Nature Biotech
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