Upfront Briefing
The FDA declined to review Moderna’s mRNA flu vaccine — a clean reminder that “filed” and “in play” aren’t always synonyms.
Also: Novocure landed an FDA approval in locally advanced pancreatic cancer, and BridgeBio posted positive Phase 3 topline for oral infigratinib in achondroplasia. Elsewhere, Novartis released final Phase 3 Vanrafia data in IgAN and Coherus priced equity at $1.75/sh.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,832.8 |
(1.6%) |
(0.2%) |
| Nasdaq 100 |
24,687.6 |
(2.0%) |
(2.2%) |
| Russell 2000 |
2,615.8 |
(2.0%) |
+5.4% |
| Healthcare (XLV) |
156.0 |
(0.2%) |
+0.8% |
| Biotech (XBI) |
123.2 |
(1.2%) |
+1.0% |
| Nasdaq Biotech (NBI) |
5,860.7 |
(1.1%) |
+2.7% |
| Clinical Trials (BBC) |
40.3 |
(0.7%) |
+4.5% |
|
- Risk-off tape: AI “disruption” angst + Cisco-led tech weakness dragged the Nasdaq complex; defensives (including Healthcare) cushioned the broader S&P.
- Healthcare (XLV) was comparatively steady as rates eased into Friday’s CPI print — a classic “hide in quality” move vs high-duration growth.
- Biotech still fell, but held up better than mega-cap tech (XBI -1.2% vs NDX -2.0%) on idiosyncratic catalyst flow.
The Big 3
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1
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FDA declines to review Moderna mRNA flu vaccine
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- Moderna received a refuse-to-file / refusal-to-review decision for its mRNA flu submission, citing concerns that the pivotal study comparator didn’t reflect best-available U.S. standard of care.
- Why it matters: This is a timing + credibility hit to the “respiratory franchise bundle” narrative (flu + Covid + RSV). Practically: it can force additional work (trial design/bridging/label discussions) and pushes revenue optionality rightward. Read-through: the FDA may be raising the bar on what counts as “adequate and well-controlled” for next-gen vaccine updates — relevant for the broader mRNA/vaccine cohort.
- Source: BioPharma Dive
- More: STAT; BioSpace
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2
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FDA approves Novocure’s Optune Pax for locally advanced pancreatic cancer
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- The FDA approved Optune Pax (tumor treating fields) for use with gemcitabine + nab-paclitaxel in locally advanced pancreatic cancer.
- Why it matters: This is a high-profile regulatory win in a tough indication and can drive a real commercial inflection if adoption sticks. Key investor debate shifts from “can they get the label?” to “can they scale utilization?” — given wear-time burden and real-world adherence risk.
- Source: FDA
- More: Barron’s
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3
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BridgeBio posts positive Phase 3 topline for oral infigratinib in achondroplasia
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- PROPEL 3 met the primary endpoint in children with achondroplasia, with statistically significant improvements in annualized height velocity and body proportionality metrics.
- Why it matters: An effective oral option is a differentiated competitive wedge vs injectable incumbents and materially de-risks BBIO’s regulatory path (now about filing strategy/timing). If durability + safety hold, this becomes a real share-shift threat in a defined rare disease market.
- Source: Company PR
- More: Reuters
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Everything Else that broke
- Novartis posts final Phase 3 ALIGN results for Vanrafia (atrasentan) in IgA nephropathy (eGFR slope / kidney function). — PR
- AbbVie sues over Botox selection for IRA Medicare negotiations. — Endpoints
- ICON stock drops after internal accounting probe disclosed. — Endpoints
- Novo Nordisk to expand Irish factory for Wegovy pill. — Endpoints
- Pharma pushes back on FDA plans for OTC drug switches. — Endpoints
- Ultragenyx restructuring includes approximately 130 layoffs. — Endpoints
- PTC Therapeutics withdraws Translarna NDA resubmission. — PR
- HanchorBio gets FDA Orphan Drug Designation for HCB101. — PR
- Innovent doses first patient in Phase 3 HER2 ADC breast cancer trial. — PR
- CRISPR Therapeutics reports Q4 and full-year 2025 results. — PR
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly
⬇️
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M&A / BD&L
- Alkermes completes acquisition of Avadel Pharmaceuticals. — PR
- Nxera Pharma licenses GPCR-targeted program to newly founded spin-out company. — BioSpace
VC / Private Financings
- No newly disclosed therapeutic biotech venture rounds in the last ~24 hours.
IPOs / Follow-Ons
- Evommune announces $125M private placement at $27.88/sh — investors undisclosed; placement agents: Morgan Stanley, Leerink, Evercore ISI, Cantor Fitzgerald, William Blair. — PR
- Xilio Therapeutics prices ~$40M offering — led by Coastlands Capital, joined by Gilead, OrbiMed, and Perceptive; Leerink Partners sole bookrunner. — PR
- Coherus Oncology prices public offering of common stock ($50.1M at $1.75/sh). — PR
- BioMarin closes $850M senior notes offering (debt). — PR
Academic Corner
- PD-1 blockade reprograms antiviral immunity and reduces the HIV reservoir. — Nature Medicine
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