Welcome back to This Week in Biotech by Biotech Blueprint, edition 121, covering biotech and pharma news from October 2nd to 8th, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Vaxcyte had the cleanest result of the week and also the most fully disclosed. Its 31-strain pneumococcal vaccine matched Pfizer’s Prevnar 20 and Merck’s Capvaxive on every strain the three vaccines share, and covers four additional strains neither competitor includes. Vaxcyte published the whole breakdown, including the two strains that only cleared the older and looser statistical bar. The stock rose about 31% and the company raised $1B within hours.
Viatris paid $1.65B for Pacira, whose lead drug starts losing exclusivity in about three years. Shionogi paid $2B for IntraBio, which sold $67.9M of product last year. Ultragenyx sold a priority review voucher, essentially a transferable coupon that lets the buyer get a faster FDA review on any drug they choose, for $210M. Meanwhile Caribou’s allogeneic CAR-T cell therapy, made from donor cells rather than the patient’s own, had FDA clearance to enter Phase 3 but couldn’t find anyone willing to fund the trial, and is shutting down research. There are seven approved CAR-T therapies and all seven use the patient’s own cells. After more than a decade and billions of dollars, no allogeneic (off-the-shelf) version has ever been approved, because the patient’s immune system clears the donor cells before they finish working. Investors were being asked to fund the next attempt at a problem nobody has solved yet.
Dutch court blocked Merck’s “under the skin” Keytruda in eight European countries on a Halozyme patent. Merck chose not to license the technology that Bristol Myers Squibb and Roche did license, and it’s now paying for that in the exact market where subcutaneous dosing was supposed to slow the Keytruda patent cliff.
Two readouts set the tone in oncology. AbbVie and Genmab’s Epkinly cut progression or death risk by 51% in newly diagnosed diffuse large B-cell lymphoma, above the roughly 40% the Street wanted. ArriVent lost more than half its value when furmonertinib missed its primary endpoint with a p-value of 0.0654.
BIOTECH/PHARMA NEWS 🧬
🔹 Vaxcyte’s OPUS-1 trial dosed 4,047 people across about 30 US sites. Pneumococcal disease causes pneumonia, meningitis and bloodstream infections, mostly in older adults, and current adult vaccines cover 20 or 21 strains, but Vaxcyte’s VAX-31 covers 31. In 3,572 adults aged 50 and older, randomized evenly to VAX-31, Pfizer’s Prevnar 20 or Merck’s Capvaxive, the vaccine matched both competitors on all 28 strains they have in common, and generated a strong enough immune response against four strains the others don’t contain to clear the trial’s superiority threshold. Strain by strain, VAX-31 cleared the bar on all 20 comparisons against Prevnar 20 and 17 of 19 against Capvaxive. Two strains, 3 and 12F, cleared only the older and looser statistical threshold rather than the stricter one, and Vaxcyte disclosed that rather than leaving it out. No vaccine-related serious adverse events, no discontinuations. The company estimates VAX-31 covers 13 to 36% more invasive pneumococcal disease than current adult vaccines. The worry going in was dilution. Each strain in a pneumococcal vaccine has to be attached to a carrier protein, and the more strains you add, the more the immune response to each one can weaken. That’s the reason nobody had gone past 21, but it didn’t happen here. Shares rose about 31%, then gave back about 10% when the company priced $474M of stock at $64 plus $500M of convertible notes. OPUS-2 and OPUS-3 read out in the first half of 2027 and the license application is planned for the first half of 2028, which leaves Pfizer and Merck a long runway to respond.
🔹 An independent monitoring committee recommended stopping argenx’s UNITY trial for futility after an interim analysis concluded the study couldn’t hit its primary endpoint in Sjögren’s disease, an autoimmune condition that attacks the glands producing tears and saliva. The interim reportedly covered more than 500 of 630 enrolled patients. No effect size was disclosed. Results hadn’t been expected until the second half of 2027, and analysts had pegged Sjögren’s at up to $1.4B peak. Shares fell about 15%. What makes this notable is that Novartis and Amgen have both now won Phase 3 trials in the same disease with different mechanisms, which suggests the problem is Vyvgart’s target rather than the indication. Vyvgart works by blocking the neonatal Fc receptor, which clears disease-causing antibodies from the body, and that mechanism has carried argenx across myasthenia gravis and CIDP. The same morning, FB102, a CD122 antibody from argenx’s $2.2B Forte acquisition, met its Phase 2 primary endpoint in 126 adults, protecting the intestinal lining through an eight-week gluten challenge at p=0.0176. No magnitude given and phase 3 is planned.
🔹 A Dutch court ordered Merck to stop making and selling Keytruda Qlex, its under-the-skin version of pembrolizumab, in eight European countries after finding it infringed a Halozyme patent on rapid subcutaneous delivery of large biologics. It follows a German preliminary injunction in December 2025 and runs alongside a US suit in New Jersey asserting 15 patents. The strategic point is the licensing decision. Bristol Myers Squibb and Roche licensed Halozyme’s enzyme for subcutaneous Opdivo and Tecentriq. Merck built its own and now faces injunctions market by market. Subcutaneous Keytruda is Merck’s main tool for moving patients onto a format that outlasts the intravenous patents, which start expiring in 2028, so every month blocked in Europe is a month of switching lost. Merck shares barely moved, and the intravenous product is unaffected.
🔹 Caribou is halting research and exploring strategic alternatives after failing to finance a Phase 3 of vispa-cel, its donor-derived CAR-T therapy for lymphoma, despite having FDA agreement on the trial design. Leerink’s Daina Graybosch said that investors “were unwilling to fund the trial.” Its myeloma program stops too. Shares fell about 25% to under $1, down from above $30 in 2021, and the company is now a reverse merger candidate. Allogeneic CAR-T means using cells from a healthy donor instead of the patient’s own. The problem has always been that the patient’s immune system recognizes those donor cells as foreign and clears them, often before they’ve finished killing the cancer. Companies have tried to get around it by knocking out genes on the donor cells and wiping out more of the patient’s immune system first, and it still hasn’t fully worked. Caribou didn’t say why investors passed, but a Phase 3 ready asset failing to raise in a week when Forbion closed $2.6B tells you something about appetite for this modality.
🔹 Viatris will pay $36.50 per share in cash, a 45% premium, for Pacira, closing by end of 2026. Pacira sells Exparel for post-surgical pain and Zilretto for knee osteoarthritis, which together did $692M in 2025, up only about 4%. What Viatris is really buying is a cash stream with a known expiry date. Settlements already let Fresenius Kabi and a Hengrui subsidiary sell a small share of US Exparel volume, rising toward 30% within three years, and broader generic erosion is expected from 2030. Zilretto’s patents run out in 2031. That timeline would scare off most branded acquirers, but Viatris is a generics company. Managing declining products and squeezing value out of expiring patents is the business they’re in. Leerink calls the deal immediately accretive while expecting no change in near term trajectory.
🔹 AbbVie and Genmab added their drug Epkinly to standard chemotherapy in newly diagnosed diffuse large B cell lymphoma, and it cut the risk of progression or death by 51%. Epkinly is a bispecific antibody, meaning it physically grabs a cancer cell with one arm and one of the patient's own T cells with the other, forcing the immune system to attack. The trial enrolled about 900 patients at intermediate or high risk, randomized 2:1 to six cycles of standard R-CHOP chemotherapy with Epkinly or with placebo. Hazard ratio was 0.49 in both the primary higher-risk group and the broader population. Analysts had modeled about 40%. Safety matched what was already known. This is the first bispecific to win a Phase 3 in newly diagnosed lymphoma, which matters because that's where doctors are actually trying to cure people rather than extend survival, and it's the largest patient group. TD Cowen called it the "undisputed standard," though worth noting the trial didn't test against Roche's Polivy, so that comparison is cross-trial inference rather than a head-to-head result. Genmab rose as much as 14%. Epkinly did $312M in the first half and TD Cowen sees $3B eventually. Overall survival data and filing timing haven’t been disclosed.
🔹 ArriVent's furmonertinib missed its primary endpoint in newly diagnosed lung cancer and the stock fell more than 50%. The trial enrolled 398 patients whose tumors carry a specific mutation called an EGFR exon 20 insertion, which shows up in a small slice of non small cell lung cancer and responds poorly to the standard targeted drugs. Patients got either furmonertinib as a once daily pill or chemotherapy. The drug delayed progression by 1.5 months, 11 versus 9.5, with a hazard ratio of 0.75. The p-value was 0.0654, just above the 0.05 threshold. Jefferies had wanted a three month gap. Response rates and investigator-assessed progression both favored the drug and survival data is still immature, but none of that rescues a missed primary endpoint. The competitive position makes it worse. J&J’s Rybrevant is already on the market, and Taiho and Cullinan have started a filing for their own drug in the same setting. An oral pill that lets patients skip chemotherapy would have been a real advantage. At 0.75 without significance, it’s a hypothesis.
WATCHLIST 👀
Merck remigromig: full first year Brunello data in diabetic macular edema on October 10, the first of September’s no-number Phase 3 wins to show its numbers
GSK/Ionis bepirovirsen: FDA decision in hepatitis B on October 26
Capricor deramiocel: FDA decision November 22 in Duchenne
PhRMA v. Kennedy: whether PhRMA moves for a preliminary injunction before GLOBE’s January 1 start
Have a great rest of your week and thanks for reading Biotech Blueprint!
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Front cover image source: STAT News