Friday: Biosimilars get a calendar (and a few bruises)

Upfront Briefing

Tape Action

Instrument Last close 1D % YTD % S&P 500 6,774.8 0.8% 15.2% Nasdaq 100 25,019.4 1.5% 19.1% Russell 2000 2,507.9 0.6% 12.5% XBI 120.0 (0.8%) 33.3% NBI 5,602.7 (0.7%) 30.0% Clinical Trials ETF (BBC) 38.6 0.0% 61.1%

• Risk-on for broad equities (NDX up 1.5% vs S&P 500 up 0.8%), but biotech didn’t get the memo (XBI down 0.8%).
• Biotech breadth was mostly red: XBI (-0.8%) and NBI (-0.7%) slipped even as the big indices finished green.
• Market data: US close Thu 18 Dec 2025.

The Big 3

1 Alvotech, Teva settle Eylea biosimilar launch date with Regeneron Alvotech and Teva have reached a settlement and license agreement with Regeneron for their proposed Eylea biosimilar, AVT06, setting a U.S. launch date for Q4 2026. Why it matters: This takes “when can we launch?” off the table: Alvotech/Teva now have a contractual U.S. entry window (Q4 2026) for AVT06, while Regeneron buys time to defend aflibercept economics—so the next debate shifts from courts to pricing, interchangeability, and share capture. Source: PR More: PR; PR; PR

2 Ipsen's FALKON trial for FOP fails primary endpoint Ipsen's pivotal Phase II FALKON trial for fibrodysplasia ossificans progressiva (FOP) did not meet its primary endpoint, leading to the study's closure. Why it matters: A pivotal miss in ultra-rare FOP is a reminder that “clean biology + small n” can still brick-wall late-stage—raising the bar for endpoint selection and clinical meaningfulness, and likely cooling near-term partnering appetite until the next dataset clarifies what actually moves flare-ups and function. Source: PR More: PR

3 US commission warns on China's biotech sector advancements A US congressional commission is raising concerns about China's growing dominance in the biotech sector, urging action to maintain US leadership. Why it matters: When a U.S. commission starts framing China’s biotech as a strategic competitiveness issue, it’s usually a precursor to policy tools (procurement limits, export controls, tighter capital/tech scrutiny). Translation: higher deal friction and diligence costs for anything with China-linked R&D, CDMO, or supply chain exposure. Source: Endpoints

Everything Else that broke

• Galapagos' GLPG3667 meets endpoint in dermatomyositis study, with SLE results pending. — PR
• FDA places a partial hold on Daiichi Sankyo and Merck’s Phase 3 lung cancer study due to a higher-than-anticipated incidence of deaths. — Endpoints
• Moderna secures new funding for its H5 pandemic influenza vaccine candidate after previous government funding was lost. — BioPharma Dive
• Novo Nordisk files combination obesity drug CagriSema for FDA approval. — BioSpace
• Insmed discontinues brensocatib in CRSsNP after Phase 2b BiRCh misses primary + secondary endpoints. — PR
• Lilly says oral GLP-1 orforglipron maintained weight loss after patients switched off injectable Wegovy/Zepbound in ATTAIN-MAINTAIN (52 weeks). — Reuters
• FDA approves RYBREVANT FASPRO (amivantamab + hyaluronidase-lpuj) as a subcutaneous formulation across all indications previously approved for IV Rybrevant. — FDA
• UK committee seeks clarity on how to fund higher medicine prices under a UK–US pharma trade deal. — Endpoints
• Tilray expands U.S. medical cannabis operations following federal rescheduling. — PR
• Abivax to be added to the Nasdaq Biotechnology Index. — PR
• Stelios Papadopoulos talks company-building, pricing pressure, innovation from China and big pharma’s future. — BioCentury
• Alphamab outlines a strategy for bispecific ADCs with lower antibody-drug ratios in crowded cancer targets. — BioCentury
• Early signals: two small molecules activate GCase in Parkinson’s disease, with Gain reporting CNS substrate reduction and Vanqua showing peripheral enzyme activation. — BioCentury
• Johnson & Johnson's hematology portfolio is poised for 2026 breakthroughs, with readouts anticipated. — Labiotech

Deal Flow

M&A / BD&L

• Regeneron / Alvotech / Teva — “Settlement + license sets Q4 2026 U.S. launch timing for AVT06 (proposed Eylea biosimilar). — PR

VC / Private Financings

• Rezubio secures $20M Series A for obesity, diabetes program. Led by Lapam Capital; participation from Frees Fund and Riverhead Capital. — PR
• Third Rock invests $165M in schizophrenia spinout. Co-led by Dexcel Pharma and Third Rock Ventures; participation from Bain Capital Life Sciences, GV, QVT, and Pictet. — BioCentury
• FoRx Therapeutics closes an insider-led $50M Series A to advance FORX-428 (PARG inhibitor) through Phase 1; investors include EQT Life Sciences, Pfizer Ventures, Novartis Venture Fund, and M Ventures. — PR
• AI startup Edison raises $70M seed for research software. Led by Triatomic Capital and Spark Capital — Endpoints

IPOs / Follow-Ons

• Celularity secures financing for strategic vision. — PR

Academic Corner

• Analysis of phase II and phase III clinical trial terminations from 2013 to 2023. — Nature RDD
• Detection of undiagnosed liver cirrhosis via AI-enabled electrocardiogram: a pragmatic, cluster-randomized clinical trial. — Nature Medicine
• FDA approves first gene therapy from a non-profit organization, but pricing and access questions remain. — Nature RDD
• Trends in target novelty in oncology R&D. — Nature RDD