Five FDA Decisions That Could Shape Biotech in Early 2026
Summary:
In the first quarter of 2026, the FDA is expected to rule on five high-profile drug applications, including fast-tracked “national priority” reviews and a gene therapy previously rejected, testing the agency’s ability to deliver speed and clarity amid leadership turnover and review delays. Decisions on obesity, rare disease, and gene therapy treatments – from Eli Lilly, Disc Medicine, Ascendis, Rhythm, and Rocket Pharma – could significantly shift competitive dynamics and investor confidence as biotech looks to sustain its late-2025 rebound.
AbbVie Signals Push for Oncology Credibility With RemeGen Deal at JPM26
Summary:
At JPM26, AbbVie emphasized that its oncology pipeline is undervalued, spotlighting a nearly $5 billion ex-China licensing deal with RemeGen for a PD-1/VEGF bispecific that places the company in one of immuno-oncology’s hottest areas. While reaffirming ambitions to lead in neuroscience and confidence in its immunology blockbusters, AbbVie positioned oncology as a growing strategic pillar, backed by an expanding internal pipeline and active dealmaking to complement its ADC and hematology franchises.
Lilly and Nvidia Deepen AI Alliance With $1B Co-Innovation Lab
Summary:
Eli Lilly and Nvidia are expanding their partnership with a new AI co-innovation lab and a commitment of more than $1 billion over five years, aiming to accelerate AI-driven drug discovery and clinical development. The collaboration combines Lilly’s R&D and lab infrastructure with Nvidia’s advanced AI, computing, and robotics platforms, focusing on generating real-world biological data and enabling a “closed-loop” discovery model that could reshape drug development, manufacturing, and commercialization.
Merck Veteran – Led Eikon Files for IPO Amid Signs of Biotech Rebound
Summary:
Eikon Therapeutics, a well-funded biotech led by former Merck executives including Roger Perlmutter, has filed to go public to support development of a growing oncology-focused pipeline, with four drugs already in human trials. Its IPO comes as signs point to a reopening biotech market in 2026, with Eikon pitching a mix of a novel discovery platform, in-licensed late-stage assets, and an experienced leadership team to attract public investors.
Novo Nordisk: Oral GLP-1s Could Claim Over One-Third of Obesity Market by 2030
Summary:
Novo Nordisk now expects oral GLP-1 weight-loss drugs to account for more than one-third of the obesity market by 2030, reflecting a shift toward a more consumer-driven market where convenience and out-of-pocket payment matter. The company believes its oral Wegovy can reach new patient groups reluctant to injections and is prioritizing a strong U.S. launch to set global adoption patterns, even as competition from Eli Lilly’s upcoming pill intensifies.
