Welcome back to This Week in Biotech by Biotech Blueprint, edition 124, covering biotech and pharma news from October 23rd to 30th, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Good data and bad stock reactions kept coming together this week. Moderna’s personalized melanoma vaccine cut the risk of recurrence or death by 42% in a 1,137-patient Phase 3, and the stock fell nearly 25%. Alnylam beat on earnings, grew product revenue about 52%, and lost a quarter of its value in a day. In both cases the drug worked but what moved the stock was the gap between the result and what people had already assumed. Moderna had quadrupled since August on a topline with no numbers in it, and Alnylam’s heart trial got bigger for the second time in six months. Conversely, Genmab’s petosemtamab halved the risk of death in head and neck cancer and added more than $7B in market value.
Lilly had a great quarter. Q3 revenue rose 39% to $24.4B and guidance moved up $5.5B, the third raise this year. Volume grew 53% while realized prices fell 15%. A day earlier, retatrutide beat Ozempic on blood sugar and more than doubled its weight loss in a head-to-head diabetes trial. Lilly keeps winning because its numbers land above an already extreme consensus, which is harder than winning a trial.
The FDA published draft guidance that would let a gene editor approved for one mutation extend to other mutations in the same gene on laboratory data alone. Prime rose 15% and Beam 8%. Also, HHS told compounders it would not enforce against six unapproved peptides that FDA scientists had argued against. One policy builds a rigorous shortcut for medicines with real mechanisms. The other waives the evidence bar entirely for products with almost none.
Treasury’s China rule finally was published this week, and it’s narrower than feared on deals and broader than expected on equity. The proposed rule would bar US investment in Chinese companies developing small molecules, biologics, vaccines and cell and gene therapies, while leaving plain licensing largely intact. Gilead paid nearly $1.3B in cash for a Chinese oral IL-23 receptor peptide the same week, which is what the rule leaves alone.
And autoimmune cell therapy took two more hits. Artiva dropped its natural killer cell program after two patient deaths and cut 94% of staff. Bristol Myers disclosed a death in its multiple sclerosis CAR-T trial.
BIOTECH/PHARMA NEWS 🧬
🔹 Lilly reported Q3 revenue of $24.4B, up 39% and roughly $2B above consensus. Mounjaro alone did $10.7B, up 65%, and Zepbound $5.3B, up 48%. Full year guidance moved to $91B to $92B from $85B to $87B, and shares rose about 6% to an all time high. The number underneath those numbers is the interesting one: volume grew 53% while realized prices fell 15%. Lilly is growing almost entirely on units, against a price environment that keeps getting worse. About $900M of the quarter came from one-off items, mostly $410M in Jardiance milestones with no further milestones remaining, plus favorable rebate adjustments. And adjusted earnings guidance landed at $35 to $36 per share, because acquired in process R&D charges from Q3 deals outweighed operating improvement. Lilly is spending its incretin windfall on pipeline as fast as it earns it. Separately, Lilly is merging its US and international divisions into “Lilly Global Markets” under Ilya Yuffa when Patrik Jonsson retires at year end. A company selling the same two molecules everywhere no longer needs two commercial organizations, and the structure is built for retatrutide’s launch.
🔹 Lilly’s retatrutide beat Ozempic in a head-to-head diabetes trial. In an open label, 80 week study of 1,298 adults on metformin, retatrutide lowered A1C by 2.2 points at both 9 mg and 12 mg versus 1.8 for Ozempic at 2 mg, from a baseline near 8.3%. Superiority was formal at 12 mg and nominal at 9 mg. Weight loss was 20.9% and 19.5% versus 9.4%. However, discontinuation for adverse events ran 7.9% and 4.8% versus 2.7%, with more diarrhea. Doubling the weight loss of the best known GLP-1 in diabetes, where weight loss is usually harder to achieve than in obesity, sets retatrutide up as Lilly’s next franchise rather than a high dose niche. Novo’s response was that Ozempic shouldn’t be judged on weight loss alone, pointing to its heart, kidney and liver outcomes data. Lilly plans to file in obesity in early 2027. Leerink models $15B in annual sales by 2032 against a $10B consensus.
🔹 Genmab’s petosemtamab, a bispecific antibody targeting both EGFR and LGR5, plus Keytruda cut the risk of death by 50% versus Keytruda alone at the first interim analysis in first line PD-L1-positive head and neck cancer. Hazard ratio 0.50 (95% CI 0.37-0.67, p<0.0001). Response also hit, with an odds ratio of 3.17 (2.06-4.89). Benefit held regardless of HPV status, which TD Cowen says supports a broad label, and there were no new safety signals. Genmab gained more than $7B in market value to above $35B. It bought the drug in an $8B takeover of Merus last year. What’s missing is all the other numbers, including median survival in each arm, absolute response rates, patient count and follow up duration. Worth noting an odds ratio of 3.17 does not mean three times the response rate, and a hazard ratio of 0.50 does not mean double the median survival. Those are different things and they get conflated constantly. Still, an overall survival win at the first look in a disease where Keytruda has been the frontline ceiling since 2019 is hard to argue with. Genmab now has a credible replacement for its Darzalex royalties before they roll off.
🔹 Merck and Moderna’s intismeran autogene plus Keytruda reduced recurrence or death by 42% versus Keytruda alone in resected high-risk melanoma: hazard ratio 0.58 (95% CI 0.45-0.75) at a median 24.6 months, with 24-month recurrence-free survival of 82.2% versus 70%. Distant metastasis-free survival had a hazard ratio of 0.62. The curves didn’t separate at all for the first six months, then diverged sharply, which is consistent with a vaccine that needs time to generate an immune response. Median time to first dose was 64 days. Discontinuation for adverse events was 7% versus 5%. Investors wanted 40 to 50%, Moderna had called 35% clinically significant, and the Phase 2 showed 44%. RBC called it “the low end” of expectations, and Moderna fell nearly 25% after a stock that had quadrupled since August. The data is clean and approval looks likely. But the two month manufacturing lag might be a bit problematic commercially.
🔹 Alnylam reported Q3 revenue of $1.46B including a one time $300M Roche milestone, with Amvuttra at $1.13B and transthyretin product revenue up 59%. The stock fell about 24%. Two things did it. Management said TTR sales will land at the low end of the $4.2B to $4.5B range, with US inventory and price as Q4 headwinds. The bigger problem was the Phase 3 trial for nucresiran, the next-gen version. Enrollment rose from about 1,750 to about 2,250 patients, after already rising from 1,250 in April, with the stated aim of preserving statistical power under conservative event rate estimates. Launch timing stays around 2030. In a trial measuring heart events, you need a certain number of events to occur before you can tell whether the drug helped. If patients on modern therapy are having fewer events than expected, that is good for patients and bad for trial math, because you need more patients or more time to prove anything. Alnylam may well be right about the reason. But a company asking for a bigger sample twice in six months is telling you its effect size estimate moved.
🔹 Treasury published its proposed COINS Act rule on Oct 26, with comments due December 7. It would prohibit US investment in Chinese companies developing or producing small molecules, biologics, vaccines, cell and gene therapies and their delivery technologies. Licensing a drug remains permitted, but equity taken by the licensor, NewCo structures, profit sharing collaborations and certain governance rights would all carry real risk. Those are precisely the structures the last two years of China deals have used. The industry is split over how far the licensing exemption actually reaches, and entry into force is likely close to the end of the first quarter of 2027. Meanwhile buyers kept buying. Gilead paid nearly $1.3B in cash for PepStar’s oral macrocyclic peptide against the IL-23 receptor, currently in Phase 1, the same target as Skyrizi and Tremfya. An all cash asset purchase with no equity attached is exactly what the rule leaves alone. Expect that to become the default template.
🔹 The FDA issued draft guidance for gene therapies that correct different mutations in the same gene. A sponsor would win a first approval for one mutation the conventional way and define what the agency calls an individualized feature space in that application. Later mutations falling inside that space could then be approved on laboratory data alone, without a new clinical study. This is the regulatory answer to Baby KJ Muldoon, the infant treated with a base editor in May 2025, where the manufacturing cost alone was $1.65M for one patient. Prime Medicine rose 15% and Beam 8%, and CMS plans to broaden its Medicaid access program for cell and gene therapies beyond sickle cell disease. This week HHS also said it will not enforce against compounders making six unapproved peptides, which a July advisory panel narrowly backed over FDA reviewers’ objections. None has been tested for safety and efficacy in clinical trials. Comments are open for two weeks. Worth saying that compounding sits outside the approval system entirely, so this isn’t a lowered standard in the way the gene editing guidance is a changed one. But it’s the same department in the same week, building a careful evidence framework in one place and declining to police a corner with no evidence in another.
🔹 Artiva discontinued AlloNK, its donor-derived natural killer cell therapy for rheumatoid arthritis and other autoimmune diseases, after two trial deaths. One patient developed a brain disorder that an investigator linked to fludarabine, the chemotherapy used to prepare patients before cell infusion. The other died suddenly about two months after treatment with no cause determined. Artiva says neither death appears related to its cells, but the FDA paused the Phase 2a, the Phase 3 stopped dosing, and the company cut 94% of staff to run a strategic review with $319.1M in cash. Days earlier, Bristol Myers disclosed that a patient in its multiple sclerosis trial of zola-cel died 44 days after infusion, after late-onset motor symptoms that didn’t respond to steroids, then septic pneumonia.
WATCHLIST 👀
Capricor deramiocel: FDA decision Nov 22 in Duchenne, the next test of the agency’s second-chance posture on rare disease
Vertex povetacicept: FDA decision Nov 30 in IgA nephropathy, with infection risk under scrutiny
Treasury COINS Act rule: comments due Dec 7; watch whether the final text clarifies licensor equity and NewCo structures
Genmab petosemtamab: full LiGeR-HN1 data including medians and absolute response rates at a future meeting
Have a great rest of your week and thanks for reading Biotech Blueprint!
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Front cover image source: https://onthepen.com/news/retatrutide-doubles-ozempic-weight