Daily Snap - 11. August 2025

Author

Joachim Eeckhout
August 11, 2025

Good morning! According to FierceBiotech, Basel is quietly emerging as Europe’s biotech powerhouse. Long dominated by pharma heavyweights Roche and Novartis, the Swiss city now boasts 800+ life sciences companies, world-class research, and a fast-growing innovation district. Much like Boston’s rise—though Boston’s star has dimmed of late—Basel has evolved from a corporate stronghold into a buzzing biotech ecosystem. I’ve seen it firsthand: the city’s biotech density is so high, you half expect the airport security line to double as a job fair.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

🚨CDC shooting: A 30-year-old man from Georgia, opened fire on the CDC headquarters in Atlanta. He killed a police officer and struck at least four buildings before he was stopped. White had attempted to enter the CDC but was prevented from doing so, after which he began shooting from a nearby pharmacy. According to authorities, he blamed the Coronavirus vaccine for his depression and suicidal thoughts. The attack left CDC employees shaken and in lockdown and reignited the debate surrounding anti-vaccine rhetoric.

💔 Genentech split: Bicycle Therapeutics will cut about 25% of its workforce and reduce spending by 30% to extend its cash runway into 2028, following Roche’s Genentech ending their immuno-oncology collaboration. The partnership, launched in 2020 with a $30 million upfront payment, had already been scaled back over the past two years. Bicycle will now focus on advancing zelenectide, its Nectin-4 candidate for metastatic urothelial cancer, toward pivotal trials and potential accelerated FDA approval.

💊 Chemo-free win: Boehringer Ingelheim has gained FDA accelerated approval for zongertinib (Hernexeos) to treat previously treated non-small cell lung cancer (NSCLC) patients with rare HER2 tyrosine kinase domain mutations, marking the company’s entry into oncology. Affecting 2%–4% of NSCLC cases, this population has limited treatment options, with Hernexeos becoming the first FDA-approved oral therapy targeting the mutation. Backed by strong trial results, including a 75% response rate in certain patients and favorable safety, the drug offers a chemo-free alternative to Enhertu.

🛑 FDA roadblock: The FDA has denied Stealth BioTherapeutics’ request to reconsider its complete response letter for elamipretide, leaving the fate of the biotech and its investigational treatment for Barth syndrome in limbo. The agency, which cited no safety or manufacturing issues, is requiring a full resubmission—Stealth’s third—which could take over two years to review despite data from only 12 patients. Elamipretide, granted multiple rare disease designations, failed its primary trial endpoint but showed an excellent safety profile and received a split advisory committee vote favoring approval. The latest setback follows staff layoffs and raises concerns over continued drug access for the small patient community.

📈 Cancer spike: The FDA has restricted the use of bluebird bio’s Skysona (elivaldogene autotemcel), after updated trial data revealed a 15% rate of hematologic malignancies—up from 4% at approval—in 10 of 67 treated patients, including one death. Approved in 2022 at $3 million as a one-time lentiviral gene therapy, Skysona already carried a boxed cancer warning, but cases of myelodysplastic syndrome and acute myeloid leukemia prompted a formal review. The label change further pressures Skysona’s already weak sales and compounds financial challenges for bluebird, which was taken private in June after struggling with slow adoption of its three high-priced gene therapies.

SPEED READ

More news

  • A mere 2 weeks after stepping down Vinay Prasad returned to CBER at the request of the FDA and is attempting to soothe concerns about over-regulation.

  • 10x Genomics will acquire Scale Biosciences for $30 million plus milestones, integrating its single-cell barcoding technologies into its portfolio to expand experiment scale and capabilities.

  • Assembly Biosciences reported positive interim results from its Phase 1b clinical trial of ABI-5366 for recurrent genital herpes. The study showed a 94% reduction in HSV-2 shedding and genital lesion rates.

  • Palisade Bio’s PALI-2108 showed 100% clinical response in Phase 1b ulcerative colitis patients, with strong biomarker improvements, extended colon exposure, and favorable safety supporting once-daily dosing ahead of a planned 2026 Phase 2 trial.

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