Upfront Briefing
Novo Nordisk’s Phase 3 REIMAGINE 2 readout put real separation on the board: CagriSema delivered superior HbA1c reduction and weight loss vs semaglutide in T2D — a clean “next-gen upgrade” setup for the franchise.
In deal/policy land, GSK returned Wave’s AATD RNA-editing program after underwhelming early data, while the FDA opened PreCheck to accelerate U.S. manufacturing facility buildouts — a potential tailwind for onshoring capex and domestic supply-chain narratives.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,976.4 |
+0.5% |
+1.9% |
| Nasdaq 100 |
25,738.6 |
+0.7% |
+1.9% |
| Russell 2000 |
2,640.3 |
+1.0% |
+6.4% |
| XBI (Biotech ETF) |
127.3 |
+2.1% |
+4.4% |
| Nasdaq Biotech |
5,917.4 |
+1.1% |
+3.7% |
| Clinical Trials ETF (BBC) |
41.9 |
+2.6% |
+8.7% |
|
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Risk-on held: small caps led (+1%), consistent with a broad “beta catch-up” session rather than mega-cap concentration.
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Macro tape: a firmer U.S. manufacturing read nudged rates higher, but equities looked through it and kept bid.
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Biotech outperformed (XBI +2.1% vs Nasdaq-100 +0.7%) — likely positioning-driven catch-up in under-owned growth plus higher beta on a green day.
- Market data: U.S. close Mon 02-Feb-2026.
The Big 3
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1
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Novo Nordisk CagriSema shows superior results vs semaglutide
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Novo Nordisk's CagriSema Phase 3 REIMAGINE 2 trial demonstrated superior HbA1c reduction and weight loss compared to semaglutide in adults with type 2 diabetes.
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Why it matters:
This is the clearest Phase 3 “switch” argument yet for migrating Ozempic/Wegovy patients onto a next-gen combo — supporting Novo’s pricing power, share defense vs Lilly, and a higher efficacy bar for fast followers across obesity + T2D.
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Source:
Endpoints
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More:
PR
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2
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GSK returns RNA editing program to Wave Life Sciences
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GSK has returned the rights to Wave Life Sciences' RNA editing program for AATD, following underwhelming early data.
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Why it matters:
Beyond Wave, this is a sentiment hit to the broader “in vivo RNA editing” cohort: partner returns tighten financing windows, raise the proof bar for durability/safety, and can shift negotiating leverage back toward pharma on future platform deals.
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Source:
Endpoints
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More:
BioSpace; BioSpace
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3
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FDA opens PreCheck to speed domestic pharma manufacturing buildouts
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The FDA began accepting requests for its PreCheck pilot, aimed at accelerating the design/build review path for new U.S. drug manufacturing facilities.
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Why it matters:
If it works, PreCheck can compress timelines for capacity adds and reshuffle advantage toward U.S.-based CDMOs and “domestic supply” strategies — a policy tailwind for onshoring capex cycles and resiliency narratives.
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Source:
FDA
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More:
Reuters
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Everything Else that broke
- FDA issues CRL for Aquestive allergy drug over packaging. — Endpoints
- FDA pushes for long-term monitoring of CAR-T autoimmune patients. — STAT
- NMD Pharma posts Phase 2a results for ignaseclant. — PR
- MoonLake wins FDA Fast Track for sonelokimab in palmoplantar pustulosis (PPP) + tees up Feb 23 Investor Day. — PR
- Skye posts early signal combining a CB1 inhibitor with Wegovy in an investigator-sponsored study (obesity combo watch). — Fierce Biotech; PR
- Sanofi signs share buyback mandate for up to €1 billion. — PR
- BioNTech's multi-modality strategy vs Moderna's mRNA pipeline. — BioSpace
- GSK plans layoffs of up to 350 R&D workers. — Fierce Biotech
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly
⬇️
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M&A / BD&L
- GSK returns RNA editing program for AATD to Wave Life Sciences. — Endpoints
- vTv Therapeutics amends Newsoara PDE4 inhibitor license: $20M upfront + milestones. — PR
- PacBio completes sale of short-read sequencing assets to Illumina. — PR
- Spring Health acquires Alma, expanding insurance reach in virtual mental health. — Endpoints
VC / Private Financings
- No major new biotech venture rounds hit top-tier wires in the last 24 hours.
- Fundraise: Santé Ventures closes $330M Fund V (early-stage biotech/medtech/digital health). — PR Newswire
IPOs / Follow-Ons
- Vaxcyte closes $632.5M public offering. — PR
Academic Corner
- AAV-delivered UGA suppressor tRNA for disease-agnostic in vivo gene therapy. — Nature Biotech
- Reprogramming CRISPR–Cas enzymes for customized genome editing. — Nature Biotech
- Customizing CRISPR–Cas PAM specificity with protein language models. — Nature Biotech
- Time-of-day immunochemotherapy in nonsmall cell lung cancer: a randomized phase 3 trial. — Nature Medicine
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