Daily Snap - 30. September 2025

Author

Joachim Eeckhout
September 30, 2025

Good morning!  Novartis is the latest big player to jump on the direct-to-consumer (DTC) trend. Starting November 1, the company will launch a direct-to-patient platform offering its psoriasis drug Cosentyx at a 55% discount for cash-paying patients. The Swiss giant is not alone, as AstraZeneca, BMS, Eli Lilly, Novo Nordisk, and Roche are all exploring similar moves. With political pressure mounting in the U.S. to bring down drug prices, more pharmaceutical companies are turning to DTC sales as a way to cut out intermediaries and lower costs for patients. Even industry lobbying groups like PhRMA are pushing the shift, planning a website that pulls together its members’ direct sales offers. Big Pharma already makes the drugs, now it looks like they’ll be running the store too.

Enjoy today’s read!

—Joachim E.

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What’s happening in biotech today?

🥊Pharma KO: AstraZeneca and Daiichi Sankyo's antibody-drug conjugate Enhertu has outperformed Roche’s Kadcyla in the phase 3 Destiny-Breast05 trial, demonstrating a statistically significant and clinically meaningful improvement in invasive disease-free survival for patients with high-risk, HER2-positive early breast cancer who have residual disease after neoadjuvant treatment. This marks the first head-to-head comparison of Enhertu and Kadcyla in this setting, further positioning Enhertu as a potentially superior post-neoadjuvant treatment option. Coupled with previous trial successes, Enhertu is being advanced as a foundational therapy in early-stage HER2-positive breast cancer, with regulatory submissions and data presentations planned for October 2025.

 🎯Endpoint miss: Enanta Pharmaceuticals’ oral antiviral candidate zelicapavir failed to meet the primary endpoint in a phase 2b trial for respiratory syncytial virus (RSV), showing only a modest 0.5-day improvement over placebo in resolving lower respiratory tract disease symptoms. However, secondary analyses revealed more promising results, with broader symptom resolution occurring 2.2 to 3.6 days faster in the general efficacy population and up to 7.2 days faster in high-risk subgroups, such as elderly patients or those with comorbidities. Hospitalization rates were also lower in the treatment group. Based on these findings, Enanta plans to advance zelicapavir into phase 3 trials.

🤝 Tag-team: BioLineRx has formed a joint venture with Norwegian biotech Hemispherian to advance GLIX1, a small molecule candidate for glioblastoma that recently received FDA investigational new drug approval and orphan drug designations from both U.S. and European regulators. Under the deal, BioLineRx will manage and fund development activities, beginning with a 40% stake in the venture that may rise to 70% over time. GLIX1, which targets a DNA repair mechanism and crosses the blood-brain barrier, will enter a phase 1/2a trial in early 2026, with initial results expected in 2027.

 🚧 Risky transport: Gilead Sciences has acquired exclusive global rights to the P-glycoprotein (P-gp) inhibitor encequidar for virology applications through a $10 million upfront deal with Health Hope Pharma (HHP), with potential milestone payments totaling up to $72.5 million. Originally developed by Hanmi Pharmaceutical and later advanced by Athenex before its bankruptcy, encequidar is being studied for its ability to enhance oral drug absorption by inhibiting P-gp in the gut. While typically used in cancer treatment with paclitaxel, Gilead may explore its use to improve antiviral drug absorption, though P-gp inhibitor interactions can pose risks.

✂️ Workforce halved: IO Biotech has laid off 50% of its workforce following the FDA’s rejection of its plan to seek approval for Cylembio, a therapeutic cancer vaccine that failed to outperform Merck’s Keytruda in a phase 3 melanoma trial. Despite early hopes and a trend toward improved overall survival, the FDA advised against submitting an application based on the current data. The company aims to conserve cash, projected to run out in Q1 2026, while it explores alternative regulatory paths, including a potential new study in the U.S. and discussions with European regulators. Cylembio utilizes IO’s T-win platform to activate T cells in tumors.

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