Issue #208·

365 shots down to 52: the daily insulin era is officially over

Eli Lilly just got the green light to replace your daily insulin ritual with a once-a-week shot, and the pricing battle with Novo Nordisk is about to get spicy. Meanwhile, half of cancer patients stayed in remission five years after a single infusion, a monkey study hints at one-shot cholesterol cures, and a Spanish biotech delivered the first-ever drug for a disease that had zero options.

Top Story Today

One Weekly Insulin Shot Just Replaced 365 Daily Ones

The FDA approved Eli Lilly's Onswik, a once-weekly basal insulin for type 2 diabetes that cuts annual injections from 365 to 52. Phase 3 data across 3,400+ patients showed it lowers blood sugar just as well as daily insulin, with comparable safety. Novo Nordisk's rival Awiqli beat it to market in March 2026, so this is now a two-horse race. Lilly hasn't revealed pricing yet, but Novo's benchmark sits around $99 per package. In a massive basal insulin market where adherence is the biggest unsolved problem, fewer needles could mean better outcomes at scale.

Why it matters: Convenience sounds like a luxury until you realize half of diabetes patients struggle with daily injection adherence. Turning 365 doses into 52 isn't just a lifestyle upgrade; it could reshape long-term outcomes across one of pharma's largest therapeutic markets.

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Clinical and Regulatory

Half of Cancer Patients Still in Remission Five Years After One Infusion

Legend Biotech reported that 50% of relapsed multiple myeloma patients remained cancer-free five years after a single CARVYKTI infusion, with no maintenance therapy. Three tested patients showed zero detectable cancer cells at one-in-a-million sensitivity. For a disease defined by endless treatment cycles, these results are fueling cautious whispers of a word oncologists rarely use: cure.

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Merck's Double-Lock Combo Gets the FDA Nod for Kidney Cancer

The FDA approved belzutifan plus lenvatinib for advanced kidney cancer after immunotherapy, the first regimen pairing a HIF-2alpha inhibitor with a kinase inhibitor. Patients went 14.8 months without progression versus 10.7 on the standard option. Analysts see Welireg eventually hitting $2.6 billion in peak sales.

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Europe Approves the First-Ever Drug for a Brain Disease That Had None

The European Commission authorized NEZGLYAL (leriglitazone) for cerebral adrenoleukodystrophy, a devastating brain disease in boys that previously had zero pharmacological treatments. In trials, 35% of patients met criteria for arrested disease versus a 10% historical rate. A small Spanish biotech, Minoryx, pulled off what pharma giants have struggled to do in neurodegeneration.

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Biogen Gets a Gold Star and a Rejection Letter on the Same Day

The FDA granted Breakthrough Therapy Designation to Biogen's next-gen SMA drug salanersen (potentially once-yearly dosing) while issuing a Complete Response Letter for high-dose Spinraza over a manufacturing paperwork issue, not clinical concerns. Biogen plans a quick resubmission while launching salanersen's Phase 3 program.

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Acadia's Alzheimer's Drug Missed Its Endpoint. They're Going to Phase 3 Anyway.

Acadia's remlifanserin missed statistical significance for Alzheimer's psychosis by a hair (p=0.0603 versus the 0.05 cutoff). The stock dropped 10-13%, but the company is charging ahead into Phase 3, betting that a refined trial design can close the gap. Zero drugs are currently approved for this indication.

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Deals and M&A

Merck KGaA Drops $11.3 Billion on the Picks and Shovels of Biotech

Merck KGaA is acquiring Bio-Techne for $11.3 billion in cash, a 36% premium, in its biggest deal in over a decade. Bio-Techne doesn't make drugs; it makes the proteins, antibodies, and reagents that every lab needs. Analysts are split on whether the price is genius or expensive hubris for a company with flat revenue growth.

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Genentech Pays $55 Million for a Ticket That Could Be Worth $1.5 Billion

Genentech signed a deal with AI-driven Earendil Labs to develop bispecific antibodies for cancer: $55 million upfront, up to $1.5 billion total. It's Earendil's second major pharma partnership this year after a $2.56 billion Sanofi deal, cementing it as arguably the hottest AI-biologics startup in the world.

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Science and Funding

One IV Dose Silenced a Cholesterol Gene in Monkeys for Nearly a Year

Researchers published data showing a single intravenous dose of an epigenetic editor knocked down PCSK9 protein by 90% and slashed LDL cholesterol by 60-70% in monkeys, with effects lasting 343 days. Unlike CRISPR, the underlying DNA stays intact and the silencing is potentially reversible. At least four companies are now racing to bring one-shot cholesterol therapy to humans.

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ADARx Raises Hundreds of Millions in One of 2026's Largest Biotech IPOs

ADARx Pharmaceuticals upsized its IPO, raising approximately $371.9 million. AbbVie kicked in another $100 million via private placement. The RNA therapeutics company has a Phase 3 program in hereditary angioedema and a broad pipeline, confirming the biotech IPO window remains wide open heading into Q4.

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