Daily Snap - 26. September 2025

Author

Joachim Eeckhout
September 26, 2025

 

Good morning! GlobalData has been training its AI crystal ball on 24 years’ worth of drug development history, and it seems to be paying off. Their upgraded “Likelihood of Approval” model, powered by 108 machine learning algorithms, can now predict whether a drug will make it through the FDA gauntlet with 85.4% accuracy. But, while this figure sounds impressive, the missing 14.6% could actually be the most valuable part, because if one of those “uncertain” drugs becomes a hit, that gap might be worth billions. So keep training, AI, you’re just 15% short of perfection.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

💸$200M hunt: UniQure announced a proposed $200 million underwritten public offering of its ordinary shares and pre-funded warrants, triggering a 247% surge in its share price to $47.50. The sharp rise was primarily driven by yesterday’s news showing promising three-year data from its Huntington’s disease gene therapy candidate, AMT-130, which led analysts to raise their price targets.

 💰BARDA bucks: Basilea has secured a contract worth up to $159 million in non-dilutive funding from the US Biomedical Advanced Research and Development Authority (BARDA) to support the development of its oral antibiotic, ceftibuten-ledaborbactam etzadroxil, for treating complicated urinary tract infections. This agreement will cover development costs, including planned Phase III trials, planned to begin by early 2027. The initiative aligns with broader efforts to combat antimicrobial resistance, a growing global health concern highlighted by the CDC and WHO.

💊Oral SERD: The FDA has approved Eli Lilly’s oral drug Inluriyo (formerly imlunestrant) for adults with metastatic, estrogen receptor-positive, HER2-negative breast cancer who have ESR1 gene mutations and whose disease has progressed after at least one hormone therapy. The approval is based on EMBER-3 trial results showing Inluriyo reduced the risk of disease progression or death by 38% compared to standard hormone therapies, extending tumor progression by a median of 5.5 months. Inluriyo, part of a new class of oral SERDs aiming to replace injectable fulvestrant, has a monthly list price of $22,500 and carries safety warnings, including for fetal harm.

🧹Workforce wipeout: Heidelberg Pharma is laying off 75% of its workforce and narrowing its research focus after the FDA rejected an imaging agent from its licensing partner Telix Pharmaceuticals, delaying a crucial $70 million milestone payment. With €33 million ($39 million) in cash at mid-2025, the company now expects to fund operations only into early 2026. To extend its cash runway into mid-2026, Heidelberg will prioritize its lead antibody-drug conjugate HDP-101 in multiple myeloma, pause development of its second ADC HDP-102, and proceed with a clinical trial application for a third, called HDP-103. Early-stage research will halt, and preclinical programs may be out-licensed as the company explores further financing options.

🧪Kidney boost: Hansa Biopharma has reported positive results from a U.S. phase 3 trial of imlifidase, its antibody-cleaving enzyme developed to help highly sensitized patients with end-stage renal disease receive kidney transplants. In the 64-patient study, those treated with imlifidase showed statistically significant improvements in kidney function at 12 months, meeting the primary endpoint measured by estimated glomerular filtration rate (eGFR). The treatment was well tolerated, with low rates of infusion reactions. Already conditionally approved in parts of Europe, Hansa plans to seek accelerated FDA review by the end of 2025, aiming for a potential U.S. approval in the third quarter of 2026.

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