Daily Bio News Summary — 2026-09-25: Lilly's weekly insulin and Merck's kidney combo lead an FDA-heavy day
Seventeen items from BioSpace, Fierce Pharma, Fierce Biotech and BioPharma Dive: FDA approvals for Lilly's once-weekly insulin Onswik and Merck's Welireg-Lenvima kidney cancer combo, Novo's $1.3B delivery deal with Nanexa, a $90M jury verdict for Nektar against Lilly, and a widening biotech IPO window.
Today’s harvest brings 17 items from four free sources — BioSpace (6), Fierce Pharma (4), Fierce Biotech (4) and BioPharma Dive (4), with one publication dated Sept. 21-23 whose cards surfaced on the Sept. 25 homepages. The batch skews toward regulatory decisions and capital markets: four FDA-related items, five deal or financing items, three public-market listings, and a pair of leadership and litigation stories. Only the harvested frontmatter is cited below; where a headline carries a specific figure, that figure is quoted as the source framed it.
FDA decisions and regulatory news
Eli Lilly won FDA approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes, which Fierce Pharma frames as a direct U.S. competitor to Novo’s Awiqli (Fierce Pharma, 2026-09-25). On the same day, Merck and Eisai’s Welireg-Lenvima combination landed an FDA nod in second-line clear cell renal cell carcinoma following a PD-(L)1 inhibitor — a move up the treatment queue for Merck’s HIF-2 alpha inhibitor (Fierce Pharma, 2026-09-25).
Enforcement also featured: the FDA hit a GLP-1 compounding pharmacy over what inspectors described as “insanitary conditions” and the risk of contaminating compounded tirzepatide and semaglutide “with filth” (BioSpace, 2026-09-24). And Compass Therapeutics said it will keep pursuing an approval path in advanced biliary tract cancer after the agency recommended a new clinical study, citing unmet need (BioSpace, 2026-09-22).
Dealmaking and partnerships
Genentech is paying $55 million upfront to Earendil Labs for discovery and early clinical work on multiple oncology bispecific antibodies, in a collaboration whose total potential value exceeds $1.5 billion (BioSpace, 2026-09-24). Novo Nordisk struck a 1.17 billion euro ($1.3 billion) deal with Nanexa to pair its long-acting injectable platform with Novo’s obesity and type 2 diabetes drugs (Fierce Biotech, 2026-09-25). Boehringer Ingelheim is selling its Shanghai biologics CDMO unit to local developer Raas Blood Products for up to about $3 million, handing over a 6,000-liter commercial facility (Fierce Pharma, 2026-09-24). And Indivior is handing its PAM drug program back to partner Addex Therapeutics ahead of the Indivior-Supernus merger (Fierce Biotech, 2026-09-25).
Public markets: the IPO window stays open
Two RNA-focused biotechs moved on the public markets the same day. ADARx Pharmaceuticals raised $446 million — the third-largest biotech IPO of 2026, per BioSpace — while City Therapeutics filed to go public, bringing the year’s count of newly public biotechs to 27 (BioSpace, 2026-09-25). Electra Therapeutics banked $350 million in its own IPO, the 21st biotech to price a listing this year (BioPharma Dive, 2026-09-17). On the reverse-merger side, North Immunology agreed to an all-stock combination with Aethlon Medical alongside an oversubscribed $180 million private placement intended to fund operations into the second half of 2028 (BioPharma Dive, 2026-09-17).
Leadership, litigation and a verdict
A New York jury awarded Nektar Therapeutics $90 million after siding with the biotech’s claim that Eli Lilly botched an analysis of their formerly partnered autoimmune drug (BioSpace, 2026-09-25). Travere Therapeutics CEO Eric Dube is stepping down after the Filspari launch, with a former Amicus Therapeutics chief executive taking over, per Fierce’s Chutes & Ladders roundup (Fierce Biotech, 2026-09-25). Separately, a legal feud in New York has put a spotlight on a business development veteran credited with pioneering the China “NewCo” dealmaking model, who faces allegations of trade secret misuse and double-dealing (Fierce Biotech, 2026-09-25).
Industry posture: Europe’s alarm, Novo’s pitch, Lundbeck’s move
Nine top European pharmaceutical board leaders pressed governments for speedier trials, IP protections and “fiscal flexibility,” warning that Europe is losing ground to the U.S. and China (BioPharma Dive, 2026-09-23). Novo Nordisk used a London capital markets day to pitch more than five “multi-blockbuster” launches by 2030 and more than $23 billion in annual pipeline sales by 2035 (BioPharma Dive, 2026-09-21). Lundbeck, meanwhile, is relocating its U.S. headquarters from Deerfield, Illinois to Greater Boston as part of a global innovation and AI push (Fierce Pharma, 2026-09-25).
What this batch is NOT telling us
The day’s harvest contains no clinical readout stories from the free sources — the Phase 2 and Phase 3 data points that surfaced on the homepages (Amgen’s Sjögren’s win, Viking’s obesity maintenance data, Roche and Ionis’ kidney-disease result, Vertex’s mid-stage kidney data, Celldex’s urticaria safety signal) were already covered in the news collection earlier this week. There is also no AI-bio platform news beyond the Genentech-Earendil tie-up, no FDA advisory committee action, and no new manufacturing or supply-chain disruptions. Notably, every item harvested from Endpoints News on this run sat behind that outlet’s soft paywall and was not written; where a free source carried the same story, the free version was kept instead.
Reading order
- Lilly’s Onswik approval — the clearest competitive shift of the day, and the second front in the Lilly-Novo rivalry this week (Fierce Pharma, 2026-09-25).
- Genentech-Earendil, $1.5B+ bispecific pact — the largest AI-biologics collaboration in the batch (BioSpace, 2026-09-24).
- Nektar’s $90M jury verdict against Lilly — a rare litigation outcome with a dollar figure attached (BioSpace, 2026-09-25).
- North Immunology / Aethlon — the cleanest read on how reverse mergers are being used by clinical-stage startups (BioPharma Dive, 2026-09-17).
- FDA’s GLP-1 compounding enforcement — the regulatory edge of the compounding debate (BioSpace, 2026-09-24).
How to read the underlying articles
Every item below is stored as a markdown file in src/content/news/ with its sourceUrl pointing at the original publication; the profile pages under src/content/companies/ carry the company background for the names tagged in each file’s companyId field.
The 17 items in this batch
- Merck, Eisai’s Welireg-Lenvima combo lands FDA nod to jump the kidney cancer queue — Fierce Pharma, 2026-09-25
- Lundbeck to move US digs to Boston as it eyes bigger innovation frontiers — Fierce Pharma, 2026-09-25
- Lilly brings more heat to Novo with FDA nod for once-weekly insulin Onswik — Fierce Pharma, 2026-09-25
- Pioneer of China NewCo model sued over double-dealing — Fierce Biotech, 2026-09-25
- Travere chief makes way for former Amicus CEO — Fierce Biotech, 2026-09-25
- Indivior hands back PAM drug to Addex ahead of Supernus merger — Fierce Biotech, 2026-09-25
- Novo inks $1.3B Nanexa deal to unlock long-acting obesity injectables — Fierce Biotech, 2026-09-25
- Nektar prevails in legal battle with Lilly over broken rezpeg partnership — BioSpace, 2026-09-25
- ADARx raises $446M in biotech’s third largest IPO of 2026, City files to go public — BioSpace, 2026-09-25
- 9 pharma leaders sound ‘alarm bells’ on biotech’s decline in Europe — BioPharma Dive, 2026-09-23
- Novo talks up drug launches in effort to win back investors — BioPharma Dive, 2026-09-21
- Electra amasses $350M in biotech’s latest big IPO — BioPharma Dive, 2026-09-17
- North Immunology joins biotech reverse merger boom with Aethlon deal — BioPharma Dive, 2026-09-17
- Boehringer Ingelheim offloads Shanghai CDMO to local antibody developer — Fierce Pharma, 2026-09-24
- Genentech makes $1.5B+ deal with AI heavyweight Earendil for cancer bispecifics — BioSpace, 2026-09-24
- FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’ — BioSpace, 2026-09-24
- Compass vows to press on with FDA application despite new trial request — BioSpace, 2026-09-22