Upfront Briefing
argenx opened Thursday with one hit and one miss: FB102, the anti-CD122 antibody it paid $2.2B for in July, cleared a Phase 2 celiac trial, while Vyvgart’s Phase 3 in Sjögren’s was stopped early. In The Hague, Halozyme got the block it was refused in July, and Merck’s subcutaneous Keytruda is now barred from eight European markets.
Allogeneic CAR-T lost another name as Caribou halted its clinical work for want of funding, while Ultragenyx turned a priority review voucher into $210M and Matchpoint banked $150M. Roche signed its fourth China deal since August, PhRMA took GLOBE to court, and the AAO meeting opens Saturday.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,801.8 |
(0.2%) |
13.8% |
| Nasdaq 100 |
31,160.1 |
(0.2%) |
23.6% |
| Russell 2000 |
2,793.2 |
(1.3%) |
11.4% |
| Healthcare (XLV) |
168.8 |
1.0% |
8.6% |
| Biotech (XBI) |
150.2 |
(0.4%) |
23.6% |
| Nasdaq Biotech (NBI) |
6,879.3 |
0.3% |
20.5% |
| Clinical Trials (BBC) |
43.3 |
0.1% |
15.0% |
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- Large-cap healthcare carried the group: Healthcare (XLV) rose 1.0% and NBI 0.3% while XBI slipped (0.4%), a large-over-small split that tracked the Russell 2000’s (1.3%) slide.
- Rates set the broader tone: the 10-year touched 5.36% intraday, its highest since April 2002, and the Fed’s September minutes (2:00pm ET) showed most officials see another hike as likely appropriate by year-end. The S&P 500 (0.2%) and Nasdaq 100 (0.2%) eased off Tuesday’s records, with Brent near $100.
- Market data: U.S. cash close Wednesday, 7 October 2026.
The Big 3
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1
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argenx’s FB102 wins in celiac as Vyvgart fails in Sjögren’s
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- FB102, the anti-CD122 antibody at the center of argenx’s $2.2B Forte takeover in July, met its primary endpoint in a 126-patient Phase 2 celiac gluten-challenge trial, improving villus height-to-crypt depth ratio at day 78 vs placebo (p=0.0176); argenx will take it into Phase 3. Separately, argenx stopped a Phase 3 of efgartigimod (Vyvgart) in Sjögren’s disease early after judging it unlikely to succeed.
- Why it matters: The celiac result backs the price argenx paid in July, when it bought Forte on Phase 1b vitiligo data with this readout still ahead. argenx gave a p-value but no effect size, so the magnitude of the histology benefit is the open question for Phase 3 sizing. Teva’s anti-IL-15 TEV-408 cleared a Phase 2a on the same endpoint last month but needs another Phase 2 first; TD Cowen models FB102 launching in 2031, three years ahead of Teva. The Sjögren’s stop removes an indication TD Cowen expected to read out positively in mid-2027 and cedes ground to Amgen’s dazodalibep, which won its first Phase 3 in September.
- Source: Fierce Biotech
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2
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Halozyme wins Dutch block on Merck’s subcutaneous Keytruda
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- The Hague’s patent court ruled that Merck’s subcutaneous Keytruda infringes Halozyme’s EP622 MDASE patent and ordered Merck to stop making and marketing it in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. The formulation uses Alteogen’s berahyaluronidase alfa; Merck called the patent invalid and is weighing next steps.
- Why it matters: The same court refused Halozyme a preliminary injunction in Denmark and Sweden in July, so the merits ruling is a genuine reversal, and it follows a 2025 German order that halted launch activity there. Eight markets will barely dent Keytruda revenue: the IV form keeps selling, and SC was only approved in Europe last November. The exposure is the 2028 US patent cliff, where SC conversion is Merck’s lifecycle answer and Halozyme is asserting 15 patents against Keytruda Qlex. TD Cowen reads the ruling as a push toward a license or settlement. Alteogen, whose ALT-B4 sits under deals with AstraZeneca, GSK, Biogen and Novartis, carries the read-across.
- Source: Endpoints
- More: Fierce Pharma; BioPharma Dive
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| 3 | Caribou halts all clinical work as allogeneic CAR-T funding dries up |
- Caribou Biosciences is discontinuing all clinical development of its off-the-shelf CAR-Ts, vispa-cel in lymphoma and CB-011 in myeloma, making a substantial cut to its 97-person workforce and exploring a merger, sale or asset sales after failing to raise capital. It held $113.8M in cash at 30 June.
- Why it matters: Caribou ran out of capital with its data intact. Vispa-cel matched Breyanzi and Yescarta on median PFS in Phase 1 this summer, and Caribou had already agreed a pivotal Phase 3 design with FDA, yet it could not fund the trial. That is the clearest marker yet that money has rotated from allogeneic to in vivo CAR-T, where Lilly, J&J, AstraZeneca and Moderna are building positions and Cellectis has already pivoted. With $113.8M at mid-year, a buyer is pricing a cash shell plus two Phase 1 assets. Allogene, the nearest public read-across with a lymphoma path, now faces the same question of who funds the last mile.
- Source: Fierce Biotech
- More: Endpoints
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Everything Else that broke
- PhRMA sued in D.C. federal court to block GLOBE, the mandatory Medicare Part B model tying payments to 19 countries’ prices from 2027, arguing it exceeds Medicare’s authority; CMS had already cut its savings estimate to $440M from $11.9B. — Endpoints
- Cerevance’s oral GPR6 inverse agonist solengepras cut daily OFF time by 0.61 hours vs placebo at 150mg in the 341-patient Phase 3 ARISE, after a 2025 Phase 2 miss; FDA talks are next. — Fierce Biotech
- Atsena’s ATSN-201 gene therapy met the microperimetry response bar in 6 of 9 X-linked retinoschisis patients at the Phase 3 dose vs 0 of 3 untreated controls in Lighthouse Parts A/B; Part C data are due 1H 2028. — Fierce Biotech
- MimiVax’s survivin vaccine SurVaxM missed its Phase 2b goal in newly diagnosed glioblastoma (n=233), with median OS of 22.8 vs 20.3 months on placebo; the company points to a prespecified age-65-and-under subgroup. — Fierce Biotech
- Novartis won FDA approval for Rhapsido in symptomatic dermographism, the first drug for that form of chronic inducible hives, on 29.3% vs 14% complete response in RemIND. — Fierce Pharma
- Cadrenal launched a strategic review after aligning with FDA on a pivotal cardiology trial. — Fierce Biotech
- WHO recommended against GLP-1 drugs for children with obesity under 10, and said adolescents should get them only after a supervised lifestyle program fails. — Endpoints
- Chan Zuckerberg Biohub expanded its virtual cell AI effort to $1.8B, with Isomorphic Labs, Meta and Google DeepMind among the backers. — Endpoints
- Bexorg won a $28.3M ARPA-H award to keep donor human brains viable for up to two weeks for drug testing. — Endpoints
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Roche signed its fourth China deal since August, a molecular-glue degrader pact with Hangzhou-based Defand worth just under $1B with under $10M upfront. — Endpoints
- Ultragenyx / undisclosed buyer — rare pediatric priority review voucher sold for $210M; a second voucher remains to monetize. — Endpoints
VC / Private Financings
- Matchpoint Therapeutics raised a $150M Series B co-led by Nextech Invest and Norwest, joined by Invus, BB Biotech, T1D Fund and Sanofi Ventures, to take oral T-cell modulator MPT-062 into the clinic next year. — Fierce Biotech
- TCGX — closed $600M Asia Life Sciences Fund I, with Shanghai and Hong Kong offices opening; fundraising across its funds now $3.1B. — Fierce Biotech
IPOs / Follow-Ons
- No notable IPOs / follow-ons in the last 24 hours. — BioBucks
Academic Corner - Nature Reviews Drug Discovery surveyed next-generation immune cell engagers for deep B cell depletion in autoimmune disease. — Nature RDD
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