Upfront Briefing
AbbVie and Genmab took a late-stage hit after Epkinly (epcoritamab) missed overall survival in a Phase 3 DLBCL trial — even though the study showed a statistically significant PFS benefit — a combination that can still force investors to recalibrate franchise upside and label-expansion probability.
Novartis, meanwhile, picked up FDA Breakthrough Therapy designation for ianalumab in Sjögren’s disease, a timing-and-probability booster for a late-stage immunology asset.
And the capital markets are at least peeking through the blinds: Agomab and SpyGlass filed for IPOs after JPM week (no promises, but the window is showing signs of life).
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,939.5 |
(0.1%) |
+1.4% |
| Nasdaq 100 |
25,527.3 |
(0.1%) |
+1.1% |
| Russell 2000 |
2,677.9 |
+0.1% |
+7.9% |
| XBI (Biotech ETF) |
124.2 |
(0.1%) |
+1.8% |
| Nasdaq Biotech |
5,758.8 |
0.0% |
+0.9% |
| Clinical Trials ETF (BBC) |
40.6 |
+0.5% |
+5.2% |
|
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Biotech was basically flat-to-mixed: XBI slipped while NBI was unchanged, even as the Russell 2000 eked out a gain.
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Clinical Trials (BBC) stood out on the upside, rising +0.5% while the S&P 500 edged down.
- Market data: U.S. close Fri 16-Jan-2026.
The Big 3
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1
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AbbVie/Genmab Epkinly misses overall survival in lymphoma study
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AbbVie and Genmab said Epkinly (epcoritamab) missed the primary endpoint of overall survival in the Phase 3 EPCORE DLBCL-1 trial in relapsed/refractory DLBCL, despite a statistically significant progression-free survival benefit — a mixed read that can still tighten expectations for earlier-line/combination expansion.
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Why it matters:
Epkinly is already commercial, but a Phase 3 OS miss in DLBCL can compress probability-weighted upside for earlier-line/combination expansions and raises competitive/lifecycle risk — i.e., it hits peak-sales math and the multiple investors are willing to pay for the franchise.
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Source:
Endpoints
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More:
Fierce Pharma;
Reuters;
PR
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2
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Novartis ianalumab gets FDA Breakthrough Therapy for Sjögren’s
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Novartis' ianalumab has received FDA Breakthrough Therapy designation for Sjögren’s disease, a move that could accelerate its review and filing, enhancing the value of this late-stage immunology asset.
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Why it matters:
Breakthrough Therapy designation is a tangible de-risking signal: it can tighten timelines via more intensive FDA interaction, increase the probability-weighted path to approval, and support a faster ramp in NPV for a late-stage immunology asset — especially in an indication where payer and physician adoption can hinge on differentiation vs standard care.
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Source:
PR
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3
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Agomab and SpyGlass file for IPOs
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Agomab and SpyGlass have filed for initial public offerings, indicating a potential resurgence in investor confidence and a more favorable financing environment for biotech companies following the JPM conference.
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Why it matters:
IPO filings are an early read-through on risk appetite: if these S-1s progress to pricing and trade well, it typically improves crossover demand, follow-on comps, and private financing leverage for SMID-cap biotech (the "window" is the ability to price, not just file).
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Source:
Reuters (Agomab);
SEC filing (SpyGlass)
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Everything Else that broke
- The Supreme Court will hear Hikma's 'skinny label' dispute against Amarin. — Endpoints
- The FDA has delayed reviews for two drugs participating in a new voucher program. — STAT
- Vedanta Biosciences has significantly reduced its workforce to concentrate resources on its Phase 3 C. diff program. — Fierce Biotech
- ImmunityBio reported encouraging early data for its off-the-shelf CAR-NK/cell therapy in rare blood cancer. — Endpoints
- The EMA published its 2025 overview of medicines approvals and recommendations. — Endpoints
- Drugmakers are preparing for MFN pacts and increased pricing pressure. — Endpoints
- The former CEO of Emergent BioSolutions has been hit with an insider trading lawsuit. — BioSpace
- The Sandoz CEO discussed plans for a generic Ozempic launch in 2026. — Endpoints
- The Novo Nordisk Foundation committed $850 million to bolster innovation in Denmark and Europe. — BioSpace
Deal Flow
M&A / BD&L
- Sanofi takeover speculation boosts Ocular Therapeutix stock. — BioSpace
VC / Private Financings
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Cytotheryx raised a $60M Series A to advance its cell therapy platform for liver disease (led by Ouroboros, with syndicate participation). —
PR
IPOs / Follow-Ons / Capital Raises
- Agomab and SpyGlass filed for IPOs. — Endpoints
- DBV Technologies received €166.7 million in gross proceeds from the full exercise of warrants tied to its March 2025 financing. — PR
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