Welcome back to This Week in Biotech by Biotech Blueprint, edition 126, covering biotech and pharma news from Nov 6th to Nov 12th, 2026.
I’ll be skipping three editions over the upcoming holidays: Nov 27, Dec 25, and Jan 1.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Reuters reported Thursday that Marty Makary’s FDA priority voucher program is shelved. This is the thing that got Revolution Medicines approved in 35 days in August. 22 companies got vouchers and 12 of those drugs are approved. But nobody has gotten a new one since Makary left in May, the committee that ran the reviews stopped meeting, and companies are reportedly being told applications still get accepted but don’t go anywhere. The FDA says the program is ongoing. There were never any published criteria and nobody was formally in charge. Reuters says it saved eight months or more on some approvals.
Pfizer borrowed money to run a Phase 3. Blackstone agreed to fund up to $1.5B of berobenatide’s development through 2028, the once monthly GLP-1 Pfizer got when it bought Metsera for up to $10B last year. Blackstone gets no ownership and no rights to the drug. They get paid if it’s approved and if it sells. Pfizer keeps control of everything. The reason this happened is that Eliquis and Ibrance both lose patent protection soon, and paying for ten Phase 3 trials out of pocket would make the next two years look worse than they already will. At the other end of the market, Rezera pulled a $200M IPO the night before it was due to price, while PepGen and Prime Medicine both raised $125M within hours of good data.
Two companies I flagged in September for announcing Phase 3 wins without any numbers finally showed them at the rheumatology meeting. Amgen’s Sjögren’s drug cleared its bar but barely, and the stock slipped. Beeline’s lupus drug posted about a 30 point response advantage at every dose. Then Beam went and did the same thing, announcing its sickle cell gene therapy hit its endpoint with no response rate disclosed, and fell 10%.
Bayer’s Sunharbo is the clean win of the week. First drug ever approved that blocks Factor XIa, 12,327 patients, 26% fewer strokes, and no extra bleeding.
BIOTECH/PHARMA NEWS 🧬
🔹 Reuters reported Thursday that the FDA has shelved the Commissioner’s National Priority Voucher program, citing six sources and internal documents. Makary launched it in June 2025 to cut reviews from ten or twelve months down to one or two. Of 22 drugs that got a voucher, 12 are approved, five of those since he left in May. No voucher has gone out since. The council of political appointees that oversaw the reviews has gone dormant, and neither Rasonque nor Merck’s cholesterol pill Lipfendra went through it. Companies were reportedly told the agency isn’t moving forward, though applications are still accepted. The nine drugs still in the program have been handed back to career scientists, which probably means normal timelines rather than the one or two months they were promised. The FDA’s public line is that work under the pilot continues. Reuters says the program sped some approvals by eight months or more, which is the real measure of what’s gone. Compass Pathways finished its psilocybin filing Monday and is about to find out what a voucher is worth now. Meanwhile the Senate health committee votes November 18 on Heidi Overton, with chairman Bill Cassidy undecided, and the drug and biologics centers have 1343 fewer people than in September 2024.
🔹 Blackstone Life Sciences will put up to $1.5B into berobenatide, the once monthly GLP-1 shot Pfizer picked up when it bought Metsera for up to $10B after outbidding Novo. The money is phased through 2028 and covers as many as ten Phase 3 trials. Blackstone gets no ownership and no rights to the drug. They get milestone payments if the FDA approves the monthly version and if it hits sales targets. Pfizer keeps full operational control. So this is borrowing, arranged so the development spending doesn’t land on Pfizer’s income statement the usual way. Leerink called it positive for cash flow over the next two years, which is the real reason it happened. Eliquis and Ibrance both lose patent protection soon and Pfizer is walking into a revenue hole. For scale on what these trials cost, Lilly’s Foundayo needed 4,700 patients over 72 weeks across two pivotal studies, and Pfizer’s program covers weight management plus knee osteoarthritis and sleep apnea. It’s one of Blackstone’s biggest drug bets, behind only the up to $2B Alnylam deal.
🔹 The FDA approved Bayer’s Sunharbo on Nov 9 for preventing a second stroke, given with antiplatelet therapy, in adults after a mild or moderate ischemic stroke or high risk TIA. It’s the first approved drug that blocks Factor XIa, and the reason people have chased this for years comes down to one problem. Every blood thinner has the same flaw, which is the clotting that causes strokes is the same clotting that stops you bleeding from a cut. Factor XIa makes clots grow once they’ve started but barely matters for sealing a wound, so blocking it should prevent strokes without the bleeding. That theory held up. In 12k adults, strokes happened in 6.2% on the drug versus 8.4% on placebo, with similar major bleeding. List price is $748.50 for 30 days. The label doesn’t cover atrial fibrillation, where this drug failed, and that’s the bigger market. Bayer needs the win regardless, with Xarelto down almost 43% to €738M in the first half. It also sets a bar for Bristol Myers and J&J’s milvexian, which Leerink still models at $2.5B by 2032 despite repeated setbacks.
🔹 Bristol Myers is merging research and development under Cristian Massacesi, currently chief medical officer, starting January 1. Robert Plenge, who came in through the $74B Celgene acquisition and has run research since 2023, stays until March 2027 to hand things over. The company says it’s about faster decisions. The context is less flattering. Eliquis did more than $14B last year and faces generics. The schizophrenia drug from the $14B Karuna purchase failed a major study and is selling below expectations. A Camzyos expansion trial failed. An experimental lung drug disappointed in October. And there’s still $2B in cost cuts to finish by the end of 2027. Putting a development person in charge of discovery tells you where the priority is. With a patent cliff this close, getting late-stage drugs over the line matters more than finding new biology.
🔹 Rezera pulled a $200M IPO the night before it was due to price, blaming market conditions. The deal was 16.67M shares at $11 to $13, with GSK saying it would take up to $25M, to fund a Phase 3 of its oral NLRP3 inhibitor in peripheral artery disease next year. Investors weren’t interested in funding a trial that hasn’t started. They were very interested in data already in hand. PepGen rose more than 90% on Tuesday after its myotonic dystrophy drug corrected an average 46.5% of splicing errors in six patients, then immediately priced $125M at $5 a share. Prime Medicine priced $125M at $3.5. It cuts the other way just as fast. Zura Bio lost two-thirds of its value after tibulizumab missed in hidradenitis suppurativa, leaving a $93M market cap against $188M in cash.
🔹 Beam’s base edited cell therapy met its primary endpoint in sickle cell disease. 31 patients with enough follow up went 12 straight months without a severe pain crisis. It’s the first pivotal win for base editing, which rewrites a single letter of DNA without cutting both strands the way CRISPR does. Secondary endpoints including hospital stays also hit. Beam did not disclose a response rate. 49 patients have been dosed, 39 adults and 10 adolescents, and one earlier death four months after infusion was attributed to busulfan, the chemotherapy patients get beforehand. Shares fell as much as 10%. This would be third to market behind Casgevy, which took until 2026 to reach $219M in 9 month sales, and Lyfgenia. Beam’s argument is shorter manufacturing and fewer cell collections. FDA filing is planned by year end, full data at ASH December 12-15.
🔹 Amgen finally showed the numbers behind its September announcement. In 648 patients with moderate to severe Sjögren’s disease, which attacks the glands that make tears and saliva, both dazodalibep doses met the primary endpoint at week 48. Disease activity fell 5.6 points on the monthly dose and 5.2 on the quarterly one, versus 3.8 on placebo. A seven point improvement was reached by 53.3% on monthly versus 34.8% on placebo. Patient-reported dryness improved 1.98 versus 1.05 points on monthly, and Amgen didn’t report dryness for the quarterly dose at all. Side effects were nasopharyngitis, urinary tract infections, hypertension and infusion reactions. It’s a real win and a small one. A 1.8-point gap over placebo, on a scale where placebo patients improved almost four points by themselves. The stock slipped. A second Phase 3 is due this quarter, and Novartis’s ianalumab is ahead at regulators.
🔹 Two Phase 3 wins in hepatitis D landed three days apart. Hepatitis D only infects people who already have hepatitis B, and it’s the most severe form of viral hepatitis. Vir’s monthly combination hit its endpoint with 44% of treated patients clearing the virus and normalizing liver enzymes at week 48, against none in the delayed treatment group. 79% cleared the virus alone. Shares rose about 12%. Two days later Mirum’s brelovitug won its second pivotal trial in 113 treatment-naive patients, with 59% on the weekly dose and 44% on the monthly meeting a combined endpoint at week 24, versus zero on delayed treatment. The endpoints aren’t the same and the timepoints differ, so you can’t line the percentages up directly. Vir’s bar is stricter. Evercore still expects Vir’s regimen to be the first line choice. Mirum files in the first half of 2027, Vir after two more trials read out early next year. Gilead’s Hepcludex, approved earlier this year, will have had the market alone for about two years.
WATCHLIST 👀
Heidi Overton: Senate health committee vote November 18; one Republican no likely sinks the nomination
Capricor deramiocel: FDA decision November 22 in Duchenne muscular dystrophy
Vertex povetacicept: FDA decision November 30 in IgA nephropathy
ASH, December 12-15: Beam’s risto-cel response rates, plus the trispecific myeloma data
Have a great rest of your week and thanks for reading Biotech Blueprint!
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Front cover image source: MLQ.ai