If you think GLP‐1s are the endgame, think again: on 2025‐11‐06 Novo Nordisk reported CagriSema cut systolic blood pressure by 10.9 mmHg and hs‐CRP by 68.9% over 68 weeks — outperforming semaglutide and placebo — and regulators may see filings in early 2026. You’ll get broader benefits: Redefine‐5 showed 18.4% mean weight loss for CagriSema versus 11.9% for semaglutide, and orforglipron (oral) delivered ~11% weight loss at 72 weeks. Startups (e.g., Syntis Bio) promise surgery‐mimetic capsules with human data due 2026. Why care? These multi‐agonists and new modalities shift value from pure weight loss to cardiovascular, inflammatory and patient‐experience endpoints, altering payer economics, trial design, manufacturing and go‐to‐market plans. Next inflection points: CagriSema regulatory milestones in Q1 2026 and upcoming Phase‐3/long‐term safety data that will set commercialization and pricing dynamics.

In the last ~14 days the in vivo gene‐editing field accelerated: Azalea Therapeutics (co‐founded by Jennifer Doudna) raised US$82M Series A led by Third Rock to advance a single‐dose dual‐vector permanent genome‐editing approach targeting an in vivo CAR‐T for B‐cell malignancies, aiming for the clinic in 12–18 months; Stylus Medicine secured $85M from investors including J&J and Eli Lilly to build next‐generation in vivo genetic medicines; and Vertex ended its Verve collaboration, reclaiming a liver program while deprioritizing certain delivery platforms. These developments shift investor appetite toward clinically directed, scalable delivery solutions, raise regulatory and safety scrutiny around vectors and durability, and create near‐term catalysts to watch: IND submissions/first dosing, preclinical safety data on novel delivery vectors, and regulatory guideline updates.

Biotech is shifting beyond GLP‐1s toward neurostimulation, surgery‐mimetics, live biotherapeutics and neuro‐metabolic (MC3R/MC4R) programs globally. Notable developments: Heuro Health is building a non‐invasive neuromodulation device plus digital behavioral platform and is engaging employers and payers via North Carolina’s State Health Plan RFI; AltrixBio raised $5 million Series A in September 2025 to begin first‐in‐human testing of oral intestinal coating LuCITM; Bloom Science’s live biotherapeutic BL‐001 produced −2.3% body weight vs placebo at 28 days with effect sustained two weeks and plans Phase II in 2026. These approaches aim to address GLP‐1 gaps—cost, injections, long‐term maintenance and GI toxicity—affecting customer adherence, payer coverage and market dynamics. Immediate milestones to watch are first‐in‐human/Phase II readouts and related payer and regulatory decisions.

Novo Nordisk on Nov. 6, 2025 reported Phase III REDEFINE‐1 data showing CagriSema (cagrilintide+semaglutide) over 68 weeks reduced systolic blood pressure by 10.9 mm Hg versus 8.8 mm Hg for semaglutide alone and 2.1 mm Hg for placebo, and cut hs‐CRP by 68.9% versus 55.4% and 16%; Novo aims to file for approval in early 2026. REDEFINE‐2 showed 15.7% weight loss in people with type 2 diabetes—below ~22–24% seen in nondiabetic arms—prompting investor concern. Retatrutide’s highest dose delivered 24.2% mean weight loss at 48 weeks and is in Phase 3. Regulators are pressing for cardiovascular outcome trials (REDEFINE‐3 is in progress), shifting benchmarks from weight loss alone to hard CV and inflammatory outcomes; near‐term catalysts include an FDA decision on oral semaglutide (year‐end 2025) and retatrutide Phase‐3 readouts (late 2025/early 2026).

Biotech funding and deals in late 2025 highlight accelerating in vivo gene editing: Azalea Therapeutics, co‐founded by CRISPR pioneer Jennifer Doudna, closed an $82M Series A to develop a single‐dose dual‐vector in vivo CAR‐T for B‐cell malignancies and plans clinical trials within 12–18 months; Editas Medicine has formally shifted to a fully in vivo CRISPR focus after preclinical data showing ~40% editing of the HBG1/2 promoter in HSCs, ~20% fetal hemoglobin expression in humanized mice at one month, and efficient liver editing in non‐human primates, targeting human proof‐of‐concept by 2027 with runway into Q2 2027; AstraZeneca agreed to spend up to $555M with Algen for AI‐driven target discovery. These developments affect patient impact, market opportunity and partnership activity, but regulatory, safety (off‐target/immunogenicity), durability and manufacturing hurdles remain; near‐term milestones include IND/CTA filings in 2026 and clinical readouts in 2026–2027.

On 2025-07-01 the U.S. Senate voted 99–1 to remove a proposed 10-year moratorium on state AI regulation from a major tax and spending bill, preserving states’ ability to pass and enforce AI-specific laws after a revised funding-limitation version also failed; that decision sustains regulatory uncertainty and keeps states functioning as policy “laboratories” (e.g., California’s SB-243 and state deepfake/impersonation laws). The outcome matters for customers, revenue and operations because fragmented state rules will shape product requirements, compliance costs, liability and market access across AI, software engineering, fintech, biotech and quantum applications. Immediate priorities: monitor federal bills and state law developments, track standards and agency rulemaking (FTC, FCC, ISO/NIST/IEEE), build compliance and auditability capabilities, design flexible architectures, and engage regulators and public comment processes.

On 2025-11-08 CRISPR Therapeutics reported Phase I results from a 15‐participant, single‐dose in‐vivo ANGPTL3 gene‐editing trial in the UK, Australia and New Zealand showing ~50% reductions in LDL cholesterol and triglycerides lasting at least 60 days; one participant with preexisting heart disease died but the death was not attributed to the treatment and no serious adverse events were linked to the therapy, and Phase II is planned for 2026. Separately, VERVE‐102 (PCSK9 base editing) delivered average LDL reductions of 53% (up to 69% in the highest dose) after one dose and was well tolerated. These early, durable effects move gene editing into common cardiovascular/metabolic markets and prioritize Phase II and long‐term follow‐up data, regulatory pathways, manufacturing scale‐up and pricing/reimbursement strategies.