Biotech outran the broad market: XBI +1.7%, NBI +1.5% and BBC +2.5% against XLV +0.3%. In single names, Genmab's petosemtamab survival win lifted GMAB 28%, Bicara fell about 48% intraday on the competitive read-across, and Geron slid after stopping its IMpactMF Phase 3 for futility.

The Fed held at 3.75–4.00% in a 10–2 vote, with Cook and Hammack dissenting in favour of a hike, and upgraded its growth assessment to “strong”; the 10-year rose 5bp to 5.04%. The S&P 500 added 0.3% for a third straight gain and the Nasdaq 100 0.5%, with the SOX up 1.75% on SK Hynix's record quarter and Oracle up 10.7% on its 2030 outlook. Brent settled 1.3% higher at $115.32.

Petosemtamab (EGFR x LGR5 bispecific, from the Merus buyout) plus Keytruda beat Keytruda alone in LiGeR-HN1, a ~700-patient Phase 3 in first-line PD-L1+ recurrent/metastatic HNSCC, hitting both co-primaries at the first interim analysis: OS HR 0.50 (95% CI 0.37–0.67, p<0.0001) and ORR odds ratio 3.17, regardless of HPV status. No medians or absolute response rate yet; no new safety signals.

Why it matters: This is the asset Genmab paid $8B for Merus to own, and an OS win at the first interim pulls the approval case forward: analysts had expected survival data in 2027, and Truist now sees a possible 2027 approval against its prior 2028 model. An HR of 0.50 on a Keytruda backbone is the bar every first-line HNSCC entrant now has to clear, which is why Bicara lost about half its value on the day with its HPV-negative-only Phase 3 not reading out until mid-2027. GMAB closed up 28%. The gaps are real: no median OS, no absolute ORR, no grade 3+ rates, and an open-label design. Phase 2 showed 28.2-month median OS in 45 patients; the full dataset at a medical meeting sets the label.

Source: Fierce Biotech

More: BioSpace; Genmab release

Lilly's TRANSCEND-T2D-2 (n=1,298, open-label, 80 weeks, type 2 diabetes on metformin ± SGLT2): retatrutide 12 mg and 9 mg cut A1C 2.2 points vs 1.8 for Ozempic 2 mg, with weight loss of 20.9% and 19.5% vs 9.4%. Discontinuations for adverse events ran 7.9% and 4.8% vs 2.7%; vomiting hit 15.0% at 12 mg vs 13.2% on Ozempic.

Why it matters: This is the triple agonist's first randomized test against the incumbent, and the weight gap is the story: 11.5 extra points at the top dose in a diabetic population, where incretin weight loss usually trails obesity trials. The A1C edge is narrower at 0.4 points, and the 9 mg A1C superiority is only nominally significant. Leerink's Risinger models $15B of 2032 retatrutide sales against roughly $10B consensus and argues the data support a branded premium before semaglutide's U.S. patent expires in 2032. The cost is tolerability: 12 mg discontinuations ran nearly three times Ozempic's, which will shape how the dose ladder gets labelled. Novo's own triple agonists are still in Phase 2.

Source: Endpoints

More: STAT; Fierce Biotech; BioPharma Dive

Q3 revenue rose 11% to $2.80B; the growth portfolio hit $1.26B (+49%), 63% of core pharma revenue, while MS fell 13% to $919M. In Apellis' first full quarter, Syfovre made $191M (+27%) and Empaveli $52M (+92%); Leqembi in-market sales were $202M (+67%) and Skyclarys $178M (+34%). FY26 non-GAAP EPS guidance rose to $12.20–13.00 from $12.00–13.00.

Why it matters: The quarter is the first clean read on the Apellis deal, closed in May: Syfovre and Empaveli added $243M, and the guided Apellis EPS drag shrank to about $0.55 from $0.85. The growth portfolio now outsells an MS franchise still eroding at a double-digit rate, so the debate moves from the base business to the pipeline. Analysts used the call to press on litifilimab, the anti-BDCA2 antibody whose pivotal lupus readouts carry much of the turnaround case, and management said growth no longer depends on more M&A while declining to rule it out. Q3 non-GAAP EPS of $2.62 absorbed $284M of acquired IPR&D, a line that will keep swinging if business development resumes.

Source: Fierce Pharma

More: Endpoints; BioSpace

Geron discontinued the 327-patient Phase 3 IMpactMF trial of Rytelo (imetelstat) in JAK-inhibitor-refractory myelofibrosis after the DMC said it was unlikely to meet its overall survival endpoint; no new safety signals. — Scrip

HHS will stop enforcing the compounding ban on six wellness peptides, including BPC-157 and TB-500, while FDA writes permanent rules. — Endpoints

Pfizer's flood-damaged Gujarat cancer-drug plant may stay shut for up to two years, which ASHP says will deepen U.S. chemotherapy shortages. — Endpoints

GSK's Q3 vaccine sales of £2.6B missed as Arexvy fell more than 20% to £195M against £231M consensus and Shingrix slipped 5% at constant currency; group sales of £8.9B were in line. — BioSpace

FDA accepted Palvella's NDA for QTORIN 3.9% rapamycin gel in microcystic lymphatic malformations with priority review and a 28 February 2027 PDUFA date, after Phase 3 SELVA hit all six prespecified endpoints. — PR

Ascletis' once-daily oral GLP-1 ASC30 cut HbA1c 1.7 points placebo-adjusted at 12 weeks and weight by up to 4.4% at 13 weeks in a 100-patient U.S. Phase 2 in type 2 diabetes. — PR

No notable M&A or BD&L since yesterday's edition.

Beijing-based BioGeometry raised more than $100M across Series A rounds led by China Life Capital for AI-driven protein design. — Endpoints

Formation Bio closed its debut $600M Drug Development Accelerator Fund (foundations, endowments, hospitals, philanthropies) to acquire and develop 10–15 programs over 3–5 years, each in a standalone entity; fund close, not a company round. — Company PR

Rapport (RAPP) priced $200M of common stock and pre-funded warrants at $21.00 (prior close $27.54), $150M of 2.25% convertible notes due 2032 (conversion ~$26.78) and a concurrent $30M private placement; Morgan Stanley, Leerink and Evercore lead. — SEC pricing term sheet

Phase 3 data showed add-on tozorakimab lowered moderate or severe COPD exacerbations versus placebo. — NEJM

Nature Biotech published a compact Cas12m variant for multiplexed in vivo gene activation. — Nature Biotech

An mRNA-LNP H5N1 vaccine protected lactating dairy cows from infection. — Nature Biotech