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Upfront Briefing
Viking spent Tuesday showing you can give patients less drug and keep most of the weight off: monthly VK2735 held 85% of induction losses. Celldex won both chronic-hives Phase 3s and still got sold, since two anaphylaxis cases outrank a 54% complete-response rate when the drug is chronic. Amgen, meanwhile, squeezed a rare Phase 3 pipeline win out of the Horizon deal. Today is loaded before it starts: FDA's panel sits on Grail's Galleri, and IMS opens in Glasgow with first-in-human in vivo BCMA CAR-T data from IASO on the docket. Also in the mix: Novartis goes back to China for a radioligand worth up to $900M, and Otsuka takes a FUS-ALS win to the FDA.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,764.6 |
0.0% |
13.4% |
| Nasdaq 100 |
30,732.4 |
0.8% |
21.9% |
| Russell 2000 |
2,889.9 |
0.5% |
16.4% |
| Healthcare (XLV) |
169.9 |
0.5% |
9.7% |
| Biotech (XBI) |
161.9 |
2.3% |
32.8% |
| Nasdaq Biotech (NBI) |
7,165.1 |
1.7% |
25.6% |
| Clinical Trials (BBC) |
49.8 |
2.4% |
32.5% |
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- Biotech outran a flat S&P 500: XBI rose 2.3%, BBC 2.4% and NBI 1.7%, with XLV up 0.5%. The day's biggest single-name moves came off readouts released before the open, with Amgen up 4.3% on its Sjögren's Phase 3 and Viking about a third higher by midday, while Celldex fell by double digits on anaphylaxis cases.
- The Nasdaq Composite closed at a record and the Nasdaq 100 added 0.8% as chipmakers extended the AI trade (Micron +5%), while a bank selloff pulled the Dow down 0.4%. Brent eased about 1% to below $100 after Trump said US and Iranian officials had a productive meeting at the UN, with Thursday's Trump–Xi summit next.
- Market data: U.S. cash close Tuesday, 22 September 2026.
The Big 3
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1
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Viking holds 85% of weight loss on monthly VK2735
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- In a 180-patient maintenance study, weekly VK2735 produced 16–19% weight loss over 21 weeks; patients then switched to monthly dosing kept 82–90% of it over 12 weeks (85% pooled) versus 61% after a switch to placebo, and every-other-week arms kept up to 97%.
- Why it matters: Monthly VK2735 held 85% of induction weight loss against 61% on placebo, with GI adverse events not meaningfully different from placebo over the 12-week window. That drops Viking into the dosing-flexibility fight Lilly and Novo are waging with oral maintenance, and it hands the VANQUISH extension studies, due to start in late 2026 or early 2027, a schedule to test. VKTX traded about a third above Monday's $30.11 close by midday. The caveats are real: 12 weeks of maintenance, top-line data only, and injectable Phase 3 readouts not until 2027. For an unpartnered asset, the dosing story strengthens the partnering case more than it shortens the path to approval.
- Source: Endpoints
- More: BioPharma Dive; BioSpace
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2
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Celldex hits two Phase 3s, then trips on anaphylaxis
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- Barzolvolimab met the primary and all key secondary endpoints in EMBARQ-CSU1 and -CSU2 (n=1,939), with 42–46% complete response at week 12 versus 9–13% on placebo and up to 54% by week 24; two probable anaphylaxis cases after a first dose sent CLDX sharply lower.
- Why it matters: On efficacy, analysts called this the best dataset yet in antihistamine-refractory chronic spontaneous urticaria: complete response in 42–46% of patients at week 12, up to 54% by week 24, and benefit in omalizumab-refractory patients. The market priced the safety instead, and CLDX fell by double digits. Two adjudicated probable anaphylaxis cases after a first dose, plus neutropenia in 9–12% of treated patients, point toward first-dose observation on any label, a real handicap against Xolair, Dupixent and Novartis' oral Rhapsido in a chronic outpatient market. The BLA is not due until 2027 and both trials run to 52 weeks, so the safety database grows before FDA sees it. The label, not the efficacy, now sets the valuation.
- Source: BioPharma Dive
- More: Fierce Biotech
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Amgen's dazodalibep wins the first of two Sjögren's Phase 3s
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- Dazodalibep, the CD40L-blocking fusion protein Amgen gained with Horizon, met its week-48 ESSDAI primary endpoint in OASIZ 301 (n≈621, moderate-to-severe systemic Sjögren's), with separation from week 4; the effect size was not disclosed, and AMGN rose 4.3%.
- Why it matters: Sjögren's has no approved disease-modifying therapy, and this is the first of the two positive Phase 3s William Blair assumes FDA will want. OASIZ 303, in patients with high symptom burden but low systemic activity, reads out in Q4 2026 and is the harder test, since it has to move dryness and fatigue rather than organ involvement. Without the ESSDAI delta, dazodalibep cannot yet be ranked against Novartis' ianalumab, which has two positive NEPTUNUS Phase 3s and the head start, or J&J's nipocalimab. For Amgen, it is a rare pipeline win from Horizon beyond the Tepezza and Uplizna label expansions, and it was worth 4.3% to a large-cap. Full data at a medical meeting decides how much of that holds.
- Source: BioPharma Dive
- More: Fierce Biotech
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Everything Else that broke
- Otsuka and Ionis' ulefnersen met the primary endpoint of the Phase 3 FUSION trial in FUS-ALS (89 enrolled), a combined function-and-survival measure; Otsuka will seek an expedited FDA pathway. — Fierce Biotech
- Vertex's inaxaplin cut UACR 42.7% at week 13 in APOL1-mediated kidney disease with modest proteinuria (n=23) and 17.3% in patients with type 2 diabetes (n=18); the pivotal AMPLITUDE interim readout is due early 2027. — Endpoints
- Roche's enicepatide (CT-388, from Carmot) cut HbA1c 2.65 points from an 8.1% baseline and body weight 15.5% at 48 weeks on the top dose in a Phase 2 in type 2 diabetes. — BioSpace
- FDA released an 18 Sep warning letter to Empower Pharmacy saying its vitamin-added tirzepatide and semaglutide compounds are essentially copies of Lilly and Novo's approved drugs. — Endpoints
- US trade officials heard testimony Tuesday in the Section 301 probe of Germany's drug reimbursement, which could end in tariffs on German goods. — Endpoints
- Compass Therapeutics will keep seeking an approval path for its biliary tract cancer drug after FDA recommended a new trial. — BioSpace
- Novo disclosed another 4,000 departures, taking its workforce reduction to about 13,000. — BioSpace
- Travere CEO Eric Dube is stepping down; former Amicus CEO Bradley Campbell takes over. — Fierce Pharma
- Bristol Myers is cutting another 265 New Jersey headquarters jobs, taking this year's announced state total above 700. — Fierce Pharma
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- Novartis / BoomRay — global licence to an undisclosed preclinical radioligand, up to $900M including an undisclosed upfront; Novartis' second China RLT in-licensing this year after Zonsen PepLib. — Fierce Biotech
- Boehringer Ingelheim / Envisagenics — multi-year, multi-target oncology collaboration worth up to $1B around AI-identified tumour-specific targets. — BioSpace
- Lexeo / Mantle Therapeutics — acquisition for $8.3M upfront, adding Friedreich ataxia assets alongside three new FA collaborations. — Fierce Biotech
VC / Private Financings
- No notable VC or private financings in the last 24 hours.
IPOs / Follow-Ons
- Iambic (IAM) filed for a Nasdaq IPO, terms not yet set; proceeds go first to IAM1363, a brain-penetrant HER2 inhibitor in Phase 1 with a registrational trial planned for early 2027. Nvidia and QIA are backers; ~$462M raised to date. — Fierce Biotech
Academic Corner - An NEJM trial found a blood-based multicancer early-detection test did not significantly reduce late-stage diagnoses versus usual care. — NEJM
- Nature Medicine said PATHFINDER 2 and NHS-Galleri advanced MCED evidence but left population-level benefit unresolved. — Nature Medicine
- PATHFINDER 2 reported safety and performance data for a blood-based MCED test in more than 35,000 participants. — Nature Medicine
- NHS-Galleri reported secondary endpoint performance data for MCED screening in more than 142,000 participants. — Nature Medicine
- A Nature Medicine study used AI-enhanced noncontrast CT to improve esophageal cancer detection at scale. — Nature Medicine
- Trastuzumab plus nivolumab with gemcitabine and cisplatin showed encouraging responses in HER2-positive biliary tract cancer. — Nature Medicine
- Structure published structures of human acetylcholinesterase tetramers bound to synaptic anchoring proteins. — Structure
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Less drug, same weight, and a label fight in hives. Back tomorrow. — BioBucks Team
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