Drug launch prices soar; mRNA shots linked to longer cancer survival — This Week in Biotech #75
ICER flags +51% net launch prices, Novo board shake-up, Tecentriq’s ctDNA-guided bladder success, Exelixis OS bump in colorectal cancer, and Ideaya eye-saving data (Oct 17-23, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 75, covering biotech & pharma news from October 17th to 23rd, 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.
In the latest episode, Hartaj Singh and I discuss vaccines for latent viruses (CMV, EBV, HSV), where antibodies aren’t enough and T cell training is essential. We unpacked why CMV is the pivotal phase 3 “platform test,” and how personalized neoantigen cancer vaccines retrain immune surveillance to cut recurrence. If these trials deliver, mRNA shifts from pandemic tool to a versatile immunology platform.
❗🚨 UPDATE: One day after this post, Moderna shared an update on their CMV program. The company said its phase 3 CMVictory trial of mRNA-1647 to prevent primary CMV infection in seronegative women failed the primary endpoint (vaccine efficacy was only 6-23% depending on case definition, but well below their targets). Moderna is halting the congenital CMV program, but will keep evaluating mRNA-1647 in bone-marrow transplant patients. Safety looked acceptable, and guidance for 2025 and breakeven by 2028 is unchanged. Read below what we think about the future of their mRNA platform.
Why we’re still constructive on the platform:
(1) The oncology pipeline continues to produce signals like the mRNA-4157 (V940) that with Keytruda cut melanoma recurrence/death 49% in phase 2b and is now in phase 3. Also, mRNA-4359 showed early response and translational activity at ESMO. Diverse readouts across cancer give the platform multiple paths to win. (2) This CMV result is a program-specific miss, not a platform safety failure. mRNA’s ability to encode several antigens and drive T cell responses remains central to latent virus and oncology strategies. (3) Management reiterated no change to near-term financial outlook and continues to advance other programs. Net: very disappointing for CMV, but the broader mRNA platform and late-stage oncology bets keep the long term thesis alive.
THIS WEEK IN BIOTECH VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
US drug launch prices are breaking orbit. ICER finds median net launch prices up 51% (2022-2024) vs inflation/GDP, with outliers (cell/gene, orphan, oncology) doing most of the damage. Pricing 23 recent launches at ICER’s benchmark would’ve saved ~$1.3–1.5B in year one.
ctDNA-guided adjuvant wins in bladder cancer. Roche’s Tecentriq after surgery for ctDNA-positive MIBC cut death risk 41% and recurrence/death 36% vs placebo. Patients who stayed ctDNA-negative avoided treatment.
mRNA COVID shots may supercharge immunotherapy. Retrospective data show near doubling of survival when an mRNA COVID vaccine lands within 100 days of starting checkpoint inhibitors (lung, melanoma). Mechanism looks like an innate/T cell “wake-up.”
Novo Nordisk board reset mid-GLP-1 arms race. Controlling shareholder will install former CEO Lars Rebien Sørensen as chair; seven directors exit at the Nov 14 EGM.
Colorectal cancer: A chemo-free combo took a step forward. Exelixis’ pill zanzalintinib plus Tecentriq (atezolizumab) helped previously treated metastatic colorectal cancer patients live longer than regorafenib (about 10.9 vs 9.4 months; 20% lower risk of death).
Saving eyes in uveal melanoma. Ideaya’s darovasertib before local therapy shrank tumors in 83%. Among patients slated for enucleation, 57% kept the eye. First systemic path to eye/vision preservation. Phase 3 running.
First randomized IV phage therapy win. Armata’s AP-SA02 + antibiotics vs antibiotics alone in Staphylococcus aureus bacteremia: Day-12 response 88% vs 58%. 0% relapse/non-response on phage vs 25% on placebo, clean safety.
Chondrosarcoma gets a randomized win. Inhibrx’s ozekibart more than doubled median time without tumor growth vs placebo and improved symptoms. BLA planned Q2’26.
BIOTECH/PHARMA NEWS 🧬
🔹 ICER says U.S. drug launch prices are climbing far faster than inflation and GDP: across 154 FDA approvals (2022-2024), the median net annual launch price rose 51%, while list prices rose 24%. Even adjusting for mix, net launch prices increased 33% per year. High-price outliers include gene/cell therapies, orphan drugs, and oncology. ICER estimates that pricing 23 recent launches at its Health Benefit Price Benchmark would have saved $1.3-$1.5B in year one. Instead, 16 drugs priced above benchmark drove $1.92B in spending vs $431-$661M at benchmark (examples: Camzyos, Briumvi, Carvykti, Leqembi, Casgevy, Winrevair, Attruby).
🔹 A large retrospective analysis from The University of Texas and University of Florida suggests mRNA COVID-19 vaccines (Pfizer/BioNTech or Moderna) given within 100 days of starting checkpoint-inhibitor immunotherapy are associated with markedly longer survival in advanced cancers, about 37 vs. 21 months in lung cancer and 30-40+ vs 27 months in metastatic melanoma. The effect wasn’t seen with non-mRNA vaccines (flu, pneumonia). Mouse work points to a plausible mechanism: mRNA shots broadly “wake up” innate and T cell immunity, making tumors more responsive to checkpoint drugs. Important cautions: the study is observational, and results were presented at ESMO with a companion Nature paper. A prospective randomized trial is planned to confirm whether timing mRNA vaccination around immunotherapy truly improves outcomes.
🔹 Novo board shake-up: The Novo Nordisk Foundation (controlling shareholder) is moving to reconstitute Novo’s board, after clashing with directors over the pace of change and U.S. execution on Wegovy. Chair Helge Lund and six independent directors won’t stand for re-election at a Nov 14 EGM. The Foundation will nominate its own chair, former Novo CEO Lars Rebien Sørensen, to lead the board for 2-3 years, aiming to tighten U.S. focus, speed decisions, and steer the CEO transition. The revamp follows May’s CEO swap (to Mike Doustdar) and a 11.5% (9k) headcount cut under a broader reset. Shares dipped 1-3% on the headlines.
CLINICAL TRIAL UPDATES 📊
🔹 In a 206-patient registrational study, Inhibrx’s ozekibart more than doubled median time without tumor growth vs placebo (5.5 vs 2.7 months; 52% lower risk of progression/death). It’s the first randomized win showing a progression-free survival benefit in chondrosarcoma, which has no approved systemic drugs. Quality of life and disease control endpoints backed the effect. Safety looked manageable. In expansion cohorts, early signals looked encouraging: colorectal cancer (with FOLFIRI) 23% response/92% disease control in heavily pretreated patients; Ewing sarcoma (with irinotecan/temozolomide) 64% response/92% disease control. Full data are due at CTOS Nov 14. BLA target Q2 2026.
🔹 Zymeworks reported first-in-human phase 1 data for ZW191, an FRα-targeted ADC, in heavily pretreated ovarian, endometrial, and NSCLC patients enrolled regardless of FRα expression. Among response-evaluable patients, ORR was 44% overall and 50% in gynecologic cancers, rising to 64% at higher dose. Safety looked manageable with no serious treatment-related AEs, discontinuations, or deaths. Zymeworks plans to begin dose optimization in ovarian cancer in 4Q25 with a goal to refine the dosing strategy and prepare for a potential registrational trial.
🔹 Moderna disclosed that its phase 3 CMVictory trial of mRNA-1647 to prevent primary CMV infection in seronegative women did not meet the primary efficacy endpoint (6–23% vaccine efficacy depending on case definition). The company will discontinue the congenital CMV program, continue evaluating mRNA-1647 in a phase 2 study in bone-marrow transplant patients, and reported no new safety concerns. Moderna said the result does not change its 2025 guidance or its goal of reaching breakeven in 2028.
🔹 Armata’s randomized phage therapy win in Staphylococcus aureus bloodstream infection: In a 42-patient phase 2a, adding IV bacteriophage cocktail AP-SA02 to best-available antibiotics beat antibiotics alone in complicated S. aureus bacteremia. At Day 12, clinical response was 88% vs 58% by site investigators. Importantly, zero AP-SA02 patients relapsed or failed one week after antibiotics or at end-of-study vs 22–25% on placebo. Safety looked clean (no drug-related SAEs), with signals of faster CRP drop, quicker culture clearance, and shorter ICU/hospital time. Small trial, but first randomized IV phage win in this setting. Shares jumped 300% on the data.
🔹 Arcturus sank 55% after interim phase 2 data for its inhaled cystic fibrosis mRNA therapy ARCT-032. In a tiny Class I cohort (n=6) dosed daily for 28 days, the prespecified lung function readout showed no meaningful gain. Still, high-resolution CT suggested biologic activity: 4/6 patients had fewer/lower-volume mucus plugs, and safety looked acceptable. A 15 mg cohort is ongoing, and a 12-week, 20-patient study is planned for 1H26.
🔹 Alector (ALEC) reported that phase 3 INFRONT-3 trial in GRN-mutant frontotemporal dementia failed on the main clinical measure. Latozinemab raised progranulin levels but showed no clinical benefit. The company is stopping the extension studies, cutting 50% of jobs, and its R&D chief leaves Dec 22. Alector will refocus on its GSK-partnered Alzheimer’s antibody nivisnebart (phase 2, interim H1 2026) and its BBB “Alector Brain Carrier” platform. Cash is $291M (runway to 2027); shares fell about 50%.
🔹 Neuphoria’s BNC210 missed phase 3 in social anxiety, halting the program. The AFFIRM-1 trial of a single 225 mg dose of BNC210 for social anxiety disorder failed the primary SUDS endpoint (public-speaking challenge) and all key secondaries. Safety was acceptable. Neuphoria will discontinue the program, conserve cash, and run a strategic review. The Merck partnership continues: MK-1167 is in a Merck-led phase 2 in Alzheimer’s, with up to $450M in potential milestones plus royalties.
🔹 Exelixis shared full phase 3 data (STELLAR-303) in metastatic colorectal cancer showing its pill zanzalintinib plus atezolizumab (immunotherapy) beat regorafenib on overall survival. Median 10.9 vs 9.4 months (20% lower risk of death). A progression-free survival trend favored the combo (3.7 vs 2.0 months), though formal significance can’t be claimed due to hierarchical testing. Safety was in line with class. Exelixis plans to file an NDA in 2025, positioning this as a chemo-free option after standard therapies.
🔹 Ideaya posted positive phase 2 data for darovasertib given before local therapy in uveal (eye) melanoma. 83% of patients had tumor shrinkage. Among those initially slated for eye removal, 57% ultimately kept the eye. In plaque-radiation candidates, 70% saw lower predicted radiation dose and 65% had a lower modeled 3-year risk of severe vision loss. Vision improved during treatment in 55-61%. Side effects were generally manageable. The drug has FDA Breakthrough Therapy status. A phase 3 is underway, and metastatic combo data that could support accelerated approval are expected late 2025-Q1 2026.
🔹 Roche reported a clear win for Tecentriq (atezolizumab) as adjuvant therapy in muscle-invasive bladder cancer using a ctDNA-guided approach (IMvigor011). In patients post-cystectomy with detectable ctDNA (higher relapse risk), Tecentriq cut the risk of death by 41% (median OS 32.8 vs 21.1 months; HR 0.59) and the risk of recurrence or death by 36% (median DFS 9.9 vs 4.8 months; HR 0.64) vs placebo. Those who stayed ctDNA-negative on surveillance had low relapse risk and avoided treatment, highlighting the “treat the right patients” value of pairing Signatera MRD testing with immunotherapy. Safety matched prior experience. Data were featured in ESMO’s Presidential Symposium and will be discussed with the FDA.
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Hey, great read as always! You always manage to make these complex topics so clear and insightful. Totally agree with your take on the mRNA platfom's potential.