Novo’s Layoffs, Novartis’ $1.4B Buy, Pancreatic Cancer Progress — This Week in Biotech #69
Job cuts to refocus Wegovy/Ozempic; pacibekitug joins Novartis; Revolution Medicines shows early first-line activity; BioNTech/DualityBio scores an ADC win (Sept 5-11, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 69, covering biotech & pharma news from September 5th to 11th, 2025.
🎙️ Biotech Blueprint brings you weekly video updates on the latest biotech and pharma news, plus in-depth podcast interviews with industry leaders. You can find us on YouTube, Spotify, and Apple Podcasts.
THIS WEEK IN BIOTECH VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Novo Nordisk’s reset is real. ~9,000 jobs cut (~11.5%), refocusing on diabetes/obesity, and free up ~$1.25B/year for supply, a Wegovy pill, and new-market launches. Translation: chasing Lilly’s lead with a leaner cost base and faster execution.
Policy watch: A draft White House order would scrutinize U.S.-China licensing, add hurdles for China-generated trial data, and push reshoring of basic meds. Not policy yet, but if enacted it could slow BD pipelines, raise timelines/costs, and redirect partnering away from China.
Deal of the week: Novartis buys Tourmaline ($1.4B). Pacibekitug (anti-IL-6) heads to phase 3 in cardiovascular risk reduction after strong hs-CRP cuts with monthly or quarterly dosing. Novartis is planting a flag in inflammation-driven cardiometabolic disease directly on Novo Nordisk’s turf.
Science bright spot in pancreatic cancer. Revolution Medicines’ daraxonrasib (broad RAS inhibitor) showed encouraging first-line activity alone and with standard chemo, and moves to a global phase 3 this quarter. Pancreatic cancer is notoriously resistant and any durable signal here matters.
Meaningful oncology win for ADCs. BioNTech/DualityBio’s HER2-targeting ADC (trastuzumab pamirtecan) beat T-DM1 on progression-free survival in a phase 3 study in China. A global HER2-low trial is underway. The next wave of HER2 ADCs is arriving.
Safety & market resets. Intercept will pull Ocaliva for primary biliary cholangitis at FDA’s request (and U.S. obeticholic acid trials are on hold), a notable retreat in liver disease. Separately, Capsida paused its STXBP1 gene-therapy study after a participant’s death, and Soleno reported a PWS patient death while on Vykat XR (physician assessed as unrelated). Expect close regulatory and community scrutiny.
BIOTECH/PHARMA NEWS 🧬
🔹 Novo Nordisk will cut about 9,000 jobs (~11.5% of its workforce), including ~5,000 in Denmark, the largest layoff in the country’s history, to save roughly $1.25B a year and refocus on diabetes and obesity as competition from Eli Lilly intensifies. The move follows a hiring surge, slowing Wegovy/Ozempic momentum, three profit warnings in 2025, and a market-cap slide of ~$450B since mid-2024. Bank of America now expects a fourth warning with Q3 results in November. New CEO Mike Doustdar says the savings will be reinvested in supply expansion, a pill version of Wegovy, and launches in new markets (including consumer/telehealth channels). Shares rose ~2% on the announcement.
🔹 Intercept pulls Ocaliva (obeticholic acid) for primary biliary cholangitis from the U.S. at FDA’s request. Intercept will voluntarily withdraw its liver drug Ocaliva for primary biliary cholangitis after the FDA asked the company to remove it. The agency also put all U.S. studies of obeticholic acid on clinical hold. Ocaliva won accelerated approval in 2016 based on lowering alkaline phosphatase, but later safety restrictions and post-marketing data raised concerns about liver injury, and confirmatory benefit hasn’t met FDA’s bar. Intercept says it disagrees with the FDA’s benefit-risk view but will comply and support a transition. Patients are advised to talk to their clinicians before making any changes.
🔹 Capsida Biotherapeutics paused its SYNRGY (CAP-002) study after the first participant died. The one-time AAV gene therapy targets STXBP1-related disorders (early-onset seizures and developmental delays). The company notified FDA and is investigating before deciding next steps. Separately, Soleno Therapeutics said a 17-year-old with Prader-Willi syndrome taking Vykat XR died from an apparent pulmonary embolus. The treating physician reported it was not related to the drug. PWS carries high baseline cardiopulmonary risk, and FDA hasn’t indicated further action.
🔹 The White House is circulating a draft executive order that would curb U.S. pharma’s ability to license drugs invented in China and tighten oversight of China-generated trial data. Provisions reportedly include mandatory CFIUS review of U.S.–China licensing deals, heightened FDA scrutiny (and added fees) for applications relying on Chinese data, and a push to reshore manufacturing of staples like antibiotics with purchasing preference once domestic supply scales. The idea has split stakeholders: tech investors such as Peter Thiel and Sergey Brin are said to support tougher limits, while Big Pharma including Pfizer warns it could choke a key source of pipeline assets. China-linked small caps slid on the headlines. Context: Western drugmakers have sharply increased China in-licensing since 2020, with ~$48B spent there in 1H25 alone. A White House spokesperson said the administration isn’t “actively considering” the order, even as national-security concerns remain a priority.
🔹 Novartis will buy Tourmaline Bio for $48 per share in cash (~$1.4B) via a tender offer expected to close in Q4, adding pacibekitug, a phase 3-ready anti-IL-6 antibody aimed at cutting residual inflammatory risk in atherosclerotic cardiovascular disease. In phase 2 (TRANQUILITY), pacibekitug lowered high-sensitivity CRP (an inflammation marker tied to cardiac events) by ~85-86% at 90 days with either monthly (15 mg) or once-quarterly (50 mg) dosing and placebo-like safety. Strategically, this positions Novartis against Novo Nordisk’s monthly ziltivekimab, with a potential convenience edge for quarterly dosing. Shares jumped ~58% for Tourmaline while Novartis was roughly flat. Analysts view the price as full and a bidding war unlikely, and note Novartis has the muscle to run the large cardiovascular outcomes trials next.
CLINICAL TRIAL UPDATES 📊
🔹 Revolution Medicines shared new data for its drug daraxonrasib in pancreatic ductal adenocarcinoma and said it will start a global phase 3 trial in the first-line metastatic setting this quarter. In longer follow up of the second-line monotherapy group, the drug was generally well tolerated and produced objective responses in about 30% of patients, with median progressionfree survival around 8 months and overall survival about 13-16 months. Early first-line results looked stronger: daraxonrasib alone showed a 47% response rate, and the combination with gemcitabine plus nab-paclitaxel reached 55%, with no new safety issues and good treatment adherence. A separate phase 3 study of second-line monotherapy is already enrolling and is expected to read out in 2026.
🔹 Avidity Biosciences (RNA) fell ~11% Thursday after unveiling a $500M stock offering, even as it reported encouraging one-year data for its experimental Duchenne therapy, del-zota. In boys with exon-44 mutations, treatment not only halted expected decline but showed gains on key function tests (time to rise, stair climb, 10 meter walk/run, upper-limb use). Muscle biomarkers also moved favorably: average dystrophin rose to ~25% of normal (with some higher) and creatine kinase dropped >80% and stayed near normal for up to 16 months. Safety looked manageable (mostly mild/moderate events and one discontinuation for hypersensitivity). Avidity says it remains on track to file for U.S. accelerated approval by the end of 2025.
🔹 Amgen and Kyowa Kirin shared top-line data from ASCEND, the long-term extension of their ROCKET phase 3 program in moderate/severe atopic dermatitis. Adults who had responded at 24 weeks largely maintained improvements in skin clearance, itch, and disease severity through ~1 year on once every 4- or 8-week dosing. Safety was consistent with earlier trials and discontinuations were low.
🔹 Ultragenyx reported longer-term phase 3 results showing its one-time AAV8 gene therapy DTX401 continued to reduce patients’ dependence on cornstarch, the current workaround to prevent dangerous low blood sugar in glycogen storage disease type Ia (GSDIa). By Week 96, both the initial treatment arm and the crossover arm achieved a ~61% mean reduction from baseline in daily cornstarch intake, with nighttime doses cut 70-75% and two-thirds of patients able to drop at least one overnight dose while maintaining low hypoglycemia, more time in the euglycemic range, and better fasting tolerance. Safety remained acceptable and consistent with earlier studies. An open-label Japanese pediatric cohort (n=3) saw a ~95% cornstarch reduction by Week 24, with all three discontinuing cornstarch entirely by Week 24–36 and preserved glycemic control. Overall, the data reinforce durable, year-two benefits and support the case for a disease-modifying option where no approved therapies address the genetic cause.
🔹 Summit Therapeutics reported longer follow-up from HARMONi that showed an improving overall-survival trend in Western patients (nominal p=0.0332 vs. chemo; North America HR ~0.70). The original primary analysis for the full population remained statistically non-significant, which is why the stock sold off despite regional signals.
🔹 REGENXBIO reported that its one-time AAV gene therapy RGX-121 for Hunter syndrome kept working through a year in the pivotal CAMPSIITE study. Cerebrospinal fluid levels of HS D2S6 (a key marker of brain disease) remained >80% lower, and most boys maintained or gained developmental skills. Early drops in HS D2S6 strongly tracked with better neurocognitive outcomes at one year, bolstering the case to use this biomarker for accelerated approval. The therapy, which delivers the IDS gene directly to the central nervous system, has been well tolerated to date. The BLA is under FDA review with a decision expected Feb 8, 2026.
🔹 Pfizer and BioNTech reported that their 2025-26 LP.8.1-adapted COVID-19 vaccine triggered a strong immune response in seniors and at-risk adults, boosting neutralizing antibodies at least fourfold within two weeks and showing a safety profile consistent with prior shots. The companies have submitted the data to FDA, saying the results support the agency’s recent approval of the updated formula for this season.
🔹 BioNTech and partner DualityBio said trastuzumab pamirtecan, a next-generation HER2-targeting antibody-drug conjugate, met the main goal in a head-to-head phase 3 study in China for previously treated, advanced HER2-positive breast cancer, slowing disease progression better than the current standard ADC (T-DM1). DualityBio plans to discuss a China filing, and a global phase 3 in HER2-low metastatic breast cancer is already underway. It’s the first phase 3 win from the companies’ 2023 ADC collaboration.
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