Upfront Briefing
Roche dropped positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy — a clean “new indication, same molecule” growth setup for obinutuzumab.
Elsewhere, Nicox said it received positive FDA feedback from its NCX 470 pre-NDA meeting, and Lilly posted a Phase 3 adjuvant win for Retevmo in RET fusion+ early-stage NSCLC.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,836.2 |
0.0% |
(0.1%) |
| Nasdaq 100 |
24,732.7 |
+0.2% |
(2.0%) |
| Russell 2000 |
2,646.7 |
+1.2% |
+6.6% |
| Healthcare (XLV) |
157.7 |
+1.1% |
+1.9% |
| Biotech (XBI) |
122.9 |
(0.3%) |
+0.8% |
| Nasdaq Biotech (NBI) |
5,917.2 |
+1.0% |
+3.7% |
| Clinical Trials (BBC) |
39.9 |
(1.1%) |
+3.4% |
|
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Small caps outperformed (Russell 2000 +1.2%) as softer inflation / lower yields pushed rate-cut expectations higher — a classic tailwind for domestically exposed, rate-sensitive names.
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Biotech was mixed: NBI +1.0% while XBI dipped — “quality/large-cap” held up better than SMID biotech beta.
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Market data: U.S. close Fri 13-Feb-2026.
The Big 3
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1
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Roche reports positive Phase 3 Gazyva results in nephropathy
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- Roche announced positive Phase 3 results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone for the autoimmune disease.
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Why it matters:
Obinutuzumab is already a proven franchise; a clean Phase 3 win in a new autoimmune indication is “line-extension alpha” — incremental peak sales with limited CMC/commercial execution risk, and potential upside if guidelines/payers expand earlier-line use.
- Source: PR
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2
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Nicox receives positive FDA feedback for NCX 470 pre-NDA
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- Nicox announced positive feedback from its pre-NDA meeting with the U.S. FDA for NCX 470, moving the drug closer to a potential regulatory submission.
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Why it matters:
Pre-NDA alignment is mainly about removing “process risk” (format, datasets, labeling expectations). For single-asset stories, it can meaningfully tighten the path to a binary regulatory event — and reduces the probability of a preventable CRL driven by filing content rather than efficacy/safety.
- Source: PR
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3
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Lilly’s Retevmo hits Phase 3 adjuvant endpoint in RET+ early-stage lung cancer
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In LIBRETTO-432, selpercatinib met the primary endpoint (investigator-assessed event-free survival) as adjuvant therapy in stage II–IIIA RET fusion+ NSCLC (n=151, 1:1 vs placebo).
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Why it matters:
This is franchise life-cycle expansion: moving into the adjuvant setting can materially grow the addressable pool and extend duration-on-therapy, which supports longer-term durability of Retevmo’s RET franchise (and helps defend share as RET competition matures in metastatic disease).
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Source:
PR
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Everything Else that broke
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Disc Medicine — FDA issued a Complete Response Letter for bitopertin in EPP; stock sold off sharply. —
PR
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STAT
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CStone — CS2009 IND cleared by FDA for Phase 2 trial. —
PR
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Beyfortus — study in Lancet Infectious Diseases suggested benefit for infants beyond the first RSV season. —
PR
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LEX Diagnostics — received FDA 510(k) clearance and a CLIA waiver for the LEX VELO System (broader point-of-care eligibility). —
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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HCW Biologics ↔ WY Biotech — formed JV (Trimmune) and signed an exclusive worldwide license for in vivo applications of HCW11-006;
Trimmune financing backed by CITIC Medical Fund and TigerYeah (TigerMed). —
PR
VC / Private Financings
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Tozaro raises £6m (cell & gene therapy manufacturing enablement) — led by Mercia Ventures (Midlands Engine Investment Fund II + Mercia funds), alongside existing investors (not disclosed). —
Source
IPOs / Follow-Ons / PIPEs
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Evommune — $125M private placement (PIPE-style financing; closing expected 17-Feb-2026). —
PR
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Immunic — oversubscribed private placement of up to $400M (upfront $200M + up to $200M via warrants).
Led by BVF; included Aberdeen, Avidity Partners, OrbiMed, RA Capital (plus others). —
PR
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Opus Genetics — $25M private placement.
Led by Adage; joined by Trails Edge and Marshall Wace. —
PR
Academic Corner
- Clinical progress of engineered cellular immunotherapies for autoimmunity. — Nature Biotech
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