Daily briefings
Editor’s Briefing: September 25, 2026
In Short. Overnight, the FDA cleared Eli Lilly’s once-weekly basal insulin Onswik for adults with type 2 diabetes, ADARx priced a $446 million RNA-interference IPO, advisers backed Grail’s multi-cancer blood test with caveats, Merck’s EyeBio eye drug matched Lucentis on vision while flagging safety analyses, and Novo Nordisk licensed Nanexa’s depot tech for longer-acting obesity shots.
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Lilly’s once-weekly basal insulin clears the FDA
Basal insulin is the steady background shot many people with type 2 diabetes take every day. On Thursday the FDA approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly version for adults with type 2 diabetes, used with diet and exercise. Lilly says the weekly schedule can cut more than 300 injections a year versus daily basal insulin. Approval rests on the QWINT phase 3 program in more than 3,400 adults; once-weekly Onswik met non-inferior A1C reduction versus daily insulin glargine or insulin degludec, with a similar overall safety profile. The label bars use in type 1 diabetes because of a higher risk of severe low blood sugar. The U.S. nod is the fourth global clearance after Europe, Mexico, and Japan; Novo Nordisk’s once-weekly Awiqli reached U.S. type 2 patients earlier in 2026. Lilly expects Onswik in the U.S. “in the coming months.” (Lilly PR; BioSpace)
ADARx prices a $446 million RNAi IPO
RNA interference (RNAi) silences the messenger RNA a cell would use to make a problem protein. Most marketed RNAi medicines still aim at liver targets. San Diego’s ADARx Pharmaceuticals priced an upsized Nasdaq IPO at $17 a share (26.3 million shares) for about $446.3 million in gross proceeds, and begins trading Friday under ADRX. BioPharma Dive also reported roughly $89 million more via a private stock sale to partner AbbVie. Lead asset onvuzosiran is in phase 3 for hereditary angioedema, a rare swelling disorder; mid-stage agazisiran spans complement-driven kidney and blood diseases plus geographic atrophy. Early phase 3 onvuzosiran data are expected by the end of 2027 per the IPO filing. (BioPharma Dive; Fierce Biotech)
Grail’s multi-cancer blood test wins a split advisory vote
No FDA-authorized device yet screens one blood draw for many cancer types at once. Grail’s Galleri test looks for methylation patterns in cell-free DNA shed into blood, then tries to point to a likely tissue of origin if a cancer signal appears. On Wednesday an FDA advisory panel voted 7-2 (one abstention) that Galleri’s probable benefits outweigh its risks. Panelists voted unanimously that the test is safe, but only narrowly backed effectiveness (6-4). Members stressed it should not replace guideline-recommended screens for breast, cervical, colorectal, and lung cancer. Grail has a premarket approval application pending; the agency usually follows its panels but is not bound by them. (BioPharma Dive; Fierce Biotech)
Merck’s EyeBio bet clears a pivotal bar, with safety homework
Diabetic macular edema is swelling in the retina’s central zone that blurs vision in people with diabetes. Standard shots such as Roche’s Lucentis (ranibizumab) block VEGF, a signal that drives leaky vessels. Merck’s remigromig, acquired with EyeBio, instead aims to help restore the blood-retinal barrier via Wnt pathway biology. In the pivotal Brunello phase 2b/3 study, both tested remigromig doses were non-inferior to ranibizumab on mean change in best-corrected visual acuity at 52 weeks. Merck also said it is analyzing higher rates of proliferative diabetic retinopathy, bleeding inside the eye, and treatment discontinuations on remigromig. Full one-year data are slated for the American Academy of Ophthalmology meeting on October 10; a second pivotal, BAROLO, is still running. (BioPharma Dive; Fierce Biotech)
Novo licenses Nanexa’s coating for longer-acting obesity shots
Novo Nordisk struck a deal worth up to about 1.17 billion euros (roughly $1.3 billion) for an exclusive global license to Nanexa’s PharmaShell platform on up to five peptide programs in obesity, type 2 diabetes, and related cardiometabolic disease. PharmaShell coats drug particles so they form a depot under the skin; as the coating dissolves, drug enters the blood. Novo wants monthly and quarterly dosing windows. Upfront plus development and regulatory milestones run up to about 615 million euros; about 550 million euros are sales milestones. The upfront size was not disclosed. (Fierce Biotech)
What to watch
pdufa.bio lists Mirum/Incyte zilurgisertib for fibrodysplasia ossificans progressiva (FOP, soft tissue turning to bone) as Upcoming September 26. October: Roche Tecentriq adjuvant MSI-H/stage III colon (October 9), Merck/Daiichi ifinatamab deruxtecan in extensive-stage small-cell lung cancer (October 10), Roche Enspryng in thyroid eye disease (October 15), Viatris/Opus MR-141 phentolamine ophthalmic (October 17). BioProcess International’s Boston conference wraps today. (pdufa.bio; BioProcess International)