Biotech took the brunt of a risk-off Friday: XBI fell 3.6%, NBI 2.6% and the small-cap Clinical Trials ETF (BBC) 5.0%, closer to the Russell 2000's 1.7% drop than to large-cap XLV, which slipped just 0.3%. One single-name standout ran the other way, with City Therapeutics closing its debut up about 24%.

The broader selloff was tech-led, as Big Tech and chipmakers slid on doubts over how long the AI buildout frenzy can run, taking the Nasdaq 100 down 2.5% and handing the S&P 500 and Nasdaq their worst week since June. September import prices, out at 8:30 ET, rose 1.1% m/m and 8.1% y/y, the biggest annual gain since July 2022.

China's Ministry of Commerce published a draft update to its technology-export catalogue that would ban foreign acquisitions of proprietary cell and gene therapy, siRNA and pathogen gain-of-function platforms, and require approval for full transfers of related target-identification technology. Drug out-licensing and outsourced R&D and manufacturing services are carved out; comments close 15 November.

Why it matters: PharmCube counts just 5 of 121 cross-border China out-licensing deals this year through 1 July that moved ownership, so the asset-licensing channel behind $120B of foreign transactions through August, per Chinese regulators, stays open. What closes is the Gracell trade: AstraZeneca's $1B buyout for the FasTCAR platform likely would not clear under this draft. Han Kun's Aaron Gu called it far better than the market expected, and a rumored May list that swept in ADCs, multispecifics and degraders did not make the published text. Roche's Rona licence last week is the template that survives. In Washington, the Moolenaar-Dingell Biotech Investment National Security Act has not advanced, so China BD&L overhang now runs in both directions.

Source: Endpoints

More: Fierce Biotech

CHMP recommended Eli Lilly's once-daily oral GLP-1 Foundayo (orforglipron) for weight management and type 2 diabetes in adults, one of six new medicines backed at its 12–15 October meeting. The opinion now goes to the European Commission for a final decision.

Why it matters: Novo's Wegovy pill won a weight-management-only CHMP opinion in May; Foundayo arrives with diabetes too, where it beat Farxiga and oral semaglutide head to head. Efficacy is the trade-off: roughly 5% to 11% weight loss at 72 weeks against 2% to 2.5% on placebo, short of injectable incretins, with A1C cuts of about 1.2 to 1.9 points. As a small molecule, orforglipron carries no fasting rules and no peptide manufacturing constraint, which matters for EU supply and price talks. Lilly has trailed Novo in the US oral launch, so Europe is a second shot at share. Next come the EC decision and country-by-country reimbursement, where obesity coverage is patchy.

Source: Endpoints

More: EMA; Fierce Pharma

FDA approved Roche's Enspryng (satralizumab) for adults with thyroid eye disease, the first IL-6 receptor inhibitor in the indication and the drug's first new use since its 2020 NMOSD approval. Patients or caregivers inject it subcutaneously at home.

Why it matters: Approval rests on SatraGO-2, where 52.9% of patients hit a clinically meaningful proptosis response versus 23.4% on placebo and over 60% improved double vision versus 25.8%. SatraGO-1 missed its 24-week primary endpoint, and rivals will sell against that. Format is the pitch: a home injection against Amgen's Tepezza, an hour-long IGF-1R infusion that sold $1.9B in 2025, and Viridian's Lumvoa, approved in June with shorter infusions and a 12-week course. Roche gets a second market for a 2020 asset without new chemistry. The commercial test is whether payers step it behind the IGF-1R drugs or let convenience win first-line share.

Source: Fierce Pharma

More: Genentech PR

HHS and FDA submitted an interim access policy for compounding certain peptides for review. — Endpoints

Novartis terminated a mid-stage Fabhalta (iptacopan) trial in lupus nephritis, citing strategic considerations in the federal trial registry. — Endpoints

Ascendis won a positive CHMP opinion for once-weekly TransCon CNP (navepegritide, Yuviwel) in children with achondroplasia. — PR

CHMP confirmed on re-examination its refusal of Omeros' narsoplimab (Yartemlea) for thrombotic microangiopathy after stem cell transplant. — PR

Fractyl's endoscopic Revita met the six-month co-primary of the 308-patient REMAIN-1 pivotal, with 5.1% weight regain versus 8.2% on sham after tirzepatide withdrawal (p=0.0023); a De Novo filing is planned for late 4Q26. — PR

Antheia won a conditional commitment for a direct loan of up to $80M from the Department of War's Office of Strategic Capital to onshore production of critical pharmaceutical ingredients. — PR

FDA's warning letter to Eurofins' Horsham, Pennsylvania testing lab cited selective recording of microbial pour-plate results dating to February 2025 and use of cracked, desiccated plates. — BioSpace

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

Nouscom (Basel) raised a €120M ($135M) oversubscribed Series D co-led by M Ventures and Revelation Partners, joined by new investors Angelini Investments, the European Investment Bank and Neva SGR, to run a single registration-enabling trial of off-the-shelf vaccine NOUS-209 for cancer interception in Lynch syndrome carriers. — Endpoints

Estuary Biotherapeutics launched with $103M, a $10M seed co-led by GV and 4BIO Capital plus a $93M Series A led by RA Capital and joined by Deep Track, Biogen New Ventures and UPMC Enterprises, to take AAV gene therapies for ADPKD toward the clinic in 2027 (EST-201, PKD2) and 2028 (EST-101). — Endpoints

City Therapeutics (CTY) closed its Friday debut at $22.40, about 24% above its upsized $18 IPO price (~$200M gross), on a day XBI fell 3.6%; lead asset CITY-FXI, a factor XI siRNA, is in Phase 1. — BioCentury

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