BioBucks Newsletter
GLP-1 suicide language heads for the shredder, Travere waits longer, and medtech M&A stays warm.
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Upfront Briefing
FDA is in “risk-calibration” mode: soften label language when evidence allows, but don’t assume faster timelines elsewhere.
GLP-1 label cleanup trims headline/liability drag; Travere’s delay pushes the next re-rating point out and extends the wait for FSGS revenue visibility.
In BD, Novartis leaning into RLT via licensing is a reminder: platform appetite is selective, but it’s alive.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,963.7 |
(0.2%) |
+1.7% |
| Nasdaq 100 |
25,741.9 |
(0.2%) |
+1.9% |
| Russell 2000 |
2,633.1 |
(0.1%) |
+6.1% |
| XBI (Biotech ETF) |
123.8 |
(0.1%) |
+1.6% |
| Nasdaq Biotech |
5,775.5 |
0.0% |
+1.2% |
| Clinical Trials ETF (BBC) |
39.8 |
+1.2% |
+3.3% |
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- Biotech held up: NBI was flat while the S&P 500 slipped.
- BBC was the standout mover, rising 1.2% on a mostly red tape.
- Market data: U.S. close Tue 13-Jan-2026.
The Big 3
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FDA asks Lilly, Novo to remove suicide warnings from GLP-1 labels
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The FDA has requested that Eli Lilly and Novo Nordisk remove suicide warnings from their GLP-1 drug labels, a move that could impact prescribing and liability for these blockbuster franchises.
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Why it matters:
Label cleanup de-risks the GLP-1 franchises: it trims litigation/headline overhang, reduces prescriber friction, and supports more durable volume + multiple into 2026.
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Source:
Endpoints
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FDA delays decision on Travere’s Filspari label expansion
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The FDA has delayed its decision on Travere's Filspari label expansion for FSGS, pushing back a key catalyst and potentially affecting near-term revenue expectations.
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Why it matters:
A 3-month slip is rarely just calendar noise: it pushes the next re-rating point out, extends the “proof” window for FSGS commercial uptake assumptions, and can weigh on near-term positioning/hedging.
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Source:
Endpoints
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3
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Novartis licenses PepLib radioligand peptide asset for $50M upfront
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Zonsen PepLib Biotech entered a worldwide license agreement with Novartis for an undisclosed peptide-based asset in radioligand therapies (RLTs).
Terms: $50M upfront + additional development/regulatory/sales milestones and tiered royalties.
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Why it matters:
Another signal that RLT remains a high-priority capital allocation area — and that “bolt-on” innovation is still getting funded.
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Source:
PR
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Everything Else that broke
- Ipsen’s IPN60340 (ICT01) gets FDA Breakthrough Therapy Designation for first-line unfit AML. — PR
- FDA requests flu vaccine label updates to include febrile seizure risk. — Endpoints
- HHS ousts members of a vaccine injury panel. — Endpoints
- Orion provides 2026 outlook; Nubeqa sales could exceed €1B. — PR
- JPM26: Merck discusses deal appetite and post-Keytruda LOE strategy. — BioSpace
- Novartis explains why it hasn’t acquired a GLP-1 asset. — BioSpace
- 2026 policy outlook looks at drug pricing and regulatory integrity. — BioCentury
Deal Flow
M&A / BD&L
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Novartis licenses PepLib radioligand peptide asset ($50M upfront + milestones + tiered royalties). —
PR
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Novartis signs ~$1.7B licensing deal with SciNeuro for Alzheimer’s antibodies ($165M upfront + up to $1.5B milestones + royalties). —
Reuters
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Eisai licenses taletrectinib from Nuvation Bio for Europe and other territories outside U.S., China and Japan (€50M upfront + up to €145M milestones + tiered royalties). —
PR
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Smith+Nephew to acquire Integrity Orthopaedics for up to $450M. —
BioWorld
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Boston Scientific to acquire Valencia Technologies to expand its urology portfolio. —
BioWorld
VC / Private Financings
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Proxima (formerly VantAI) raises an oversubscribed $80M seed round (DCVC led; NVIDIA’s NVentures participated). —
PR
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Converge Bio raises a $25M Series A to build foundation models for protein design/drug discovery. —
PR
IPOs / Follow-Ons
- No notable IPOs / Follow-Ons in the last 24 hours.
Academic Corner
- A fasting-mimicking diet in patients with mild-to-moderate Crohn’s disease: a randomized controlled trial. — Nature Medicine
- Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. — Nature Medicine
- Histone methyltransferase inhibition hampers prostate cancer. — Nature RDD
- Boosting CAR T cell efficacy. — Nature RDD
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See you tomorrow for more JPM updates. — BioBucks Team
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