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Upfront Briefing
The FDA refused to review Moderna’s influenza vaccine filing — a rare “refuse-to-file / no-review” outcome that forces package rework, not just a timing slip. Read-through for the respiratory/vaccine complex: what counts as an acceptable package may be tightening, widening timeline dispersion across upcoming filings.
Meanwhile, atopic dermatitis stole the biotech tape: Nektar posted durable REZOLVE-AD maintenance data with infrequent dosing, and Evommune reported positive Phase 2a top-line results for EVO301. Deal flow stayed active too: Chugai exercised an option around Araris’ ADC linker-payload platform, Memo Therapeutics paired with CSL on recombinant polyclonal IgG tech, and ILiAD landed a $115M Series B led by RA Capital.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,941.8 |
(0.3%) |
+1.4% |
| Nasdaq 100 |
25,127.6 |
(0.6%) |
(0.5%) |
| Russell 2000 |
2,679.8 |
(0.3%) |
+8.0% |
| Healthcare (XLV) |
155.3 |
(0.6%) |
+0.3% |
| Biotech (XBI) |
125.3 |
(0.6%) |
+2.9% |
| Nasdaq Biotech (NBI) |
5,897.5 |
(1.2%) |
+3.3% |
| Clinical Trials (BBC) |
41.0 |
(0.1%) |
+6.0% |
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Risk-off tape: S&P slipped (0.3%) and growth led lower (Nasdaq 100 (0.6%)) — a reminder that “flat index” days can still be painful under the hood.
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Biotech underperformed: NBI (1.2%) vs XBI (0.6%) — large-cap weakness + headline-driven regulatory risk (Moderna flu) kept bid muted.
The Big 3
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1
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FDA refuses to review Moderna's influenza vaccine application
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- The FDA has refused to review Moderna's influenza vaccine application, leading Moderna to accuse the agency of shifting standards.
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Why it matters:
“Refuse-to-file / no-review” is the worst kind of delay: it doesn’t just push timing, it forces a re-work of the package. For Moderna, that can mean a full-season slip (commercial + perception hit), and for the broader vaccine complex it raises the bar on what the FDA expects in flu submissions (read-through: higher regulatory/CMC uncertainty, wider timeline dispersion).
- Source: STAT
- More: Endpoints; Fierce Biotech
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2
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Nektar posts durable atopic dermatitis maintenance data for rezpegaldesleukin (REZOLVE-AD)
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New REZOLVE-AD maintenance data showed durable disease control with monthly and quarterly dosing across key endpoints (including EASI-75 maintenance).
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Why it matters:
This is a “real-world competitive” dataset: durable responses with infrequent dosing is exactly the bar versus Dupixent and the next wave of immunology entrants. If durability holds in larger populations, it de-risks Phase 3 design and expands partnering / strategic optionality (and forces the Street to re-underwrite the asset as more than a transient responder story).
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Source:
Nektar IR
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More:
PR
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3
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Evommune reports positive Phase 2a top-line data for EVO301 in atopic dermatitis
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EVO301 met its primary endpoint at week 12, with rapid, statistically significant EASI reductions versus placebo.
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Why it matters:
Atopic dermatitis is a mega-market dominated by Dupixent; credible mid-stage efficacy from a new mechanism (IL-18 axis) is the kind of signal that can pull forward partnering interest and reshape the competitive map. Investor lens: still early and dose/Phase 3 execution risk remains, but AD is one of the few places where “clean efficacy + tolerability” can rapidly translate into strategic value.
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Source:
Company PR
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More:
Fierce
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Everything Else that broke
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NIH stops low-dose Xarelto + aspirin arm in CAPTIVA stroke trial for safety/futility. —
Fierce Pharma
- US appeals court upholds Louisiana 340B pharmacy law. — Endpoints
- Isomorphic Labs claims advance with new AI drug design engine. — Endpoints
- Physicians urge FDA to reverse CRL for myopia drug. — BioCentury
- FDA accelerated approval messaging vs CRL reality. — BioCentury
- Lilly's Orna deal part of in vivo CAR-T takeout trend. — BioCentury
- Hengrui and Kailera oral obesity pill in line with competition. — BioCentury
- Hansa Biopharma reports Q4, full-year 2025 results, BLA submission. — PR
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly
⬇️
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M&A / BD&L
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Chugai exercises option to license Araris’ AraLinQ linker-payload ADC platform for a target; broader agreement cites potential consideration up to ~$780M (upfront undisclosed).
— PR
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Memo Therapeutics & CSL sign collaboration + option for recombinant polyclonal IgG tech; milestones up to CHF 265M (≈$328M) for first product + royalties.
— PR
VC / Private Financings
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ILiAD Biotechnologies raises $115M Series B for vaccine (whooping cough). Led by RA Capital; joined by Janus Henderson Investors and BNP Paribas Asset Management Alts (plus existing/strategic backers).
— Endpoints
IPOs / Follow-Ons
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Sutro Biopharma prices $110M underwritten offering. —
Company IR
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Galecto prices $275M underwritten public offering. —
Business Insider
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Nektar announces proposed $300M public offering (subject to market conditions). —
PR
Academic Corner
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Identifying 3D signal overlaps in spatial transcriptomics data with ovrlpy. —
Nature Biotech
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Reprogramming CRISPR–Cas enzymes for customized genome editing. —
Nature Biotech
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Practical weight-management workflow tested in primary care (stepped-wedge cluster-randomized). —
Nature Medicine
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That’s it for today — if your filing strategy feels “final,” the FDA would like a word. See you tomorrow. BioBucks Team
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