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Upfront Briefing
AbbVie and Genmab sent epcoritamab out for another lap — a phase 3 DLBCL win that skipped the chemo entirely and still trimmed progression-or-death risk by ~60%. Sanofi notched a rare-disease checkmark for Nexviazyme in infantile-onset Pompe, and Roche landed a 15 October FDA date for Enspryng in thyroid eye disease.
On the money side, Nuvectis tapped the market for $100M at $20 a share — because open windows are for climbing through. Three readouts and a raise before most desks finished their coffee.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,440.4 |
1.2% |
8.5% |
| Nasdaq 100 |
29,774.8 |
2.3% |
18.1% |
| Russell 2000 |
3,010.4 |
0.0% |
20.0% |
| Healthcare (XLV) |
160.7 |
0.2% |
3.4% |
| Biotech (XBI) |
158.3 |
1.9% |
30.3% |
| Nasdaq Biotech (NBI) |
6,563.1 |
1.3% |
15.0% |
| Clinical Trials (BBC) |
52.5 |
2.9% |
39.6% |
|
- Healthcare itself lagged (XLV +0.2%), but higher-beta biotech rode the risk-on bid — XBI +1.9%, clinical-stage BBC +2.9% — with wide single-name dispersion: Evommune sank ~35% after scrapping EVO756 on a Phase 2b chronic spontaneous urticaria miss.
- The tape's lift was a megacap-tech relief rally: Alphabet jumped ~5% on its Dow inclusion (replacing Verizon), with Tesla, Amazon and the semis higher and Rocket Lab's $8B Iridium takeout adding to the bid — all against US–Iran talks set for Tuesday in Qatar keeping a bid under oil.
- Market data: U.S. cash close Monday, 29 June 2026.
The Big 3
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1
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Phase 3 win for epcoritamab combo in R/R DLBCL
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In the Phase 3 EPCORE DLBCL-4 trial, epcoritamab (Genmab/AbbVie; GMAB, ABBV) plus lenalidomide cut the risk of progression or death by roughly 60% versus R-GemOx chemo in relapsed/refractory DLBCL after ≥1 prior line, meeting its primary PFS endpoint with safety consistent with the individual agents. Full data come at a future meeting.
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Why it matters: This is the first Phase 3 to show epcoritamab working in a chemo-free doublet in 2L+ DLBCL — a ~60% PFS benefit over R-GemOx, a standard salvage regimen. It pushes the CD3xCD20 bispecific upstream from its DLBCL-1 monotherapy base and straight at the setting where it competes with CAR-T (Yescarta, Breyanzi) and Roche's Lunsumio/Columvi. For GMAB, lymphoma is the entire equity story; for ABBV it's post-Humira pipeline depth. The watch item is durability: OS wasn't called today, and DLBCL-1's monotherapy OS missed — so the meeting data is what converts this into filings and share.
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Source:
BioSpace
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More:
Targeted Oncology;
AbbVie
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2
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Sanofi says Nexviazyme hit all phase 3 Pompe endpoints
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Sanofi's Phase 3 Baby-COMET study — single-arm, 17 treatment-naïve infants with infantile-onset Pompe disease (IOPD) — met its primary endpoint (alive and free of invasive ventilation at 52 weeks) and all secondary endpoints, with safety consistent with avalglucosidase alfa. Sanofi plans a US filing in IOPD; data come at ICNMD in Florence on 8 July.
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Why it matters: The package is small and uncontrolled — 17 infants, single-arm — but in IOPD, where untreated babies rarely reach their first birthday, ventilator-free survival at 52 weeks is the endpoint regulators weight, and Nexviazyme cleared it plus every secondary. It backs a US IOPD filing for a drug already approved here in late-onset disease and in IOPD in some ex-US markets, extending the avalglucosidase franchise against legacy Myozyme/Lumizyme. The catch is durability of that read at n=17 against gene-therapy and next-gen ERT programs circling the same ultra-orphan population.
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Source:
Sanofi
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More:
Sanofi Media Room
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| 3 | Roche’s Enspryng gets FDA Priority Review in TED |
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The FDA accepted and granted Priority Review to Roche's sBLA for Enspryng (satralizumab) in thyroid eye disease, setting a 15 October 2026 decision date. The filing rests on the Phase 3 SatraGO-1 and SatraGO-2 studies; if approved, Enspryng would be the first at-home subcutaneous option in TED.
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Why it matters: Priority review gives Roche a dated 15 October catalyst in TED — and a third entrant behind Amgen's Tepezza and Viridian's just-approved Lumvoa. The pitch is convenience and mechanism: an at-home subcutaneous IL-6R antibody versus Tepezza's IGF-1R infusions, leaning on an Enspryng safety record already built in NMOSD. But the pivotal package is split — SatraGO-2 hit its proptosis endpoint (53% vs 23% at week 24), while SatraGO-1 missed statistical significance (49% vs 31%). That one-of-two miss is the swing factor for the active-plus-chronic label breadth Roche wants, and it's what the October decision turns on.
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Source:
Roche
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More:
Investing.com
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Everything Else that broke
- FDA expanded ZORYVE cream 0.3% to plaque psoriasis in children as young as 2. — PR
- Evommune dropped EVO756 after a phase IIb miss in chronic spontaneous urticaria. — BioCentury
- FDA gene therapy regulator Vijay Kumar is leaving the agency. — STAT
- BioCryst is shuttering all internal discovery and closing its Birmingham, AL site by year-end to pivot to external partnerships, cutting ~$30M in opex (FY adjusted-opex guidance now $420–440M); Orladeyo commercial and clinical programs are unaffected. — Fierce Biotech
- AstraZeneca detailed the Phase 3 Mulberry/Chestnut data behind Strensiq successor efzimfotase alfa in hypophosphatasia (RGI-C 1.67 vs 0 on placebo at Week 25), the asset it tips for $3–5B peak sales — though the adult Hickory trial missed its 6MWT primary. — Fierce Biotech
- HHS power consolidation is driving an FDA leadership reshuffle. — BioCentury
- NEJM retracted pivotal Tavneos data after two academic authors requested the move. — Endpoints
- Abivax posted positive maintenance data for obefazimod in refractory ulcerative colitis. — PR
- DBV is still working with FDA on the VIASKIN Peanut BLA path for ages 4 to 7. — PR
- 4DMedical won Australian TGA clearance for CT:VQ imaging from routine chest CT. — PR
- Devonian reported a $1.9M quarterly loss and ended April with $0.7M in cash. — PR
- Laplace won FDA IDE approval for the TRIUMPH pivotal tricuspid valve trial. — PR
Deal Flow
| BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Innovent and Lilly struck a mainland China commercialization deal for Verzenios. — PR
- Orion licensed European rights to a nivolumab biosimilar from Shilpa Medicare. — PR
- Tilray acquired HelloMD to expand patient access in Canadian medical cannabis. — PR
VC / Private Financings
- Xellar raised $50M in Series A and A+ financing for 3D bio-intelligence infrastructure. — PR
IPOs / Follow-Ons
- Talawar Therapeutics is going public on Nasdaq (TLWR) via a merger with SPAC JATT II, paired with an oversubscribed $225M PIPE led by Access Biotechnology (with Bain Capital Life Sciences, Deep Track, RA Capital, Janus Henderson) — ~$285M combined to fund IL-13/IL-18 bispecific TALA-125 in atopic dermatitis. — Fierce Biotech
- Nuvectis priced a $100M public offering at $20.00 per share. — PR
Academic Corner - Experiment-guided AlphaFold3 resolved protein ensembles consistent with measured experimental data. — Nature Biotech
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That's all for today — three readouts, zero chemo in the winning arm, and an October date for the calendar. — BioBucks Team
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