Daily Snap - 10. September 2025

Author

Joachim Eeckhout
September 10, 2025

 

Good morning! For the first time in four years, COVID is no longer among the CDC’s top 10 causes of death. New 2024 data shows the U.S. death rate fell nearly 4%—the lowest since the pandemic began—driven by fewer COVID-related deaths and a sharp drop in overdoses. Yet heart disease and cancer remain the leading killers, a reminder of the challenges still ahead for the biotech industry. But the progress shows what’s possible and why advancing new treatments and preventive care can truly change the future of public health. Keep up the good work, biotech people!

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

💰Series B: Epigenic Therapeutics, a China-based company specializing in epigenetic gene modulation therapies, has raised $60 million in a Series B funding round. The funding will accelerate the clinical development of its lead candidates, EPI-003 for chronic hepatitis B and EPI-001 for hypercholesterolemia, while also advancing preclinical programs and enhancing proprietary platforms such as EPIREG, which enables gene silencing via DNA methylation and histone modification.

🏭CDMO KR: Amid ongoing tariff uncertainties under the Trump administration’s trade policies, South Korea’s Samsung Biologics has signed a $1.3 billion contract manufacturing deal with an undisclosed U.S.-based pharmaceutical company, set to run through the end of 2029. This marks Samsung Bio’s second-largest contract since its 2011 founding and adds to a series of recent high-value agreements, including a $531 million deal in May and a $1.2 billion contract last October. Despite global CDMO slowdowns post-COVID-19, Samsung Bio has maintained growth, driven by expanded capacity and a new manufacturing plant. Other Korean firms like Lotte Biologics and Matica Biotechnology also continue securing U.S. contracts.

🦶Wound warrior: Former Pfizer executive Suneet Varma has been appointed CEO of Intent Biologics, a newly launched regenerative medicine startup spun out from Mayo Clinic-affiliated Rion. Backed by Rion’s platform and a perpetual global license, Intent is unusually advanced for a startup, with a phase 3 trial in diabetic foot ulcers planned for this year and several other late-stage studies set for 2026. Its lead candidate, PEP Biologic, is a first-in-class exosome-based topical therapy designed to promote tissue regeneration and reduce inflammation. The therapy showed promising results in a phase 2 trial, significantly improving healing outcomes compared to standard care.

🧳 Layoff shuffle: Lundbeck is restructuring its global operations by transitioning to a partnership model in 27 markets, resulting in the layoff of 602 employees, though many are expected to join partner companies. The company will collaborate with Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals to maintain access to its medicines in these regions, which accounted for 12% of its 2024 revenue. This move, expected to be completed by December 1, is part of a broader capital reallocation strategy aimed at focusing resources on high-growth areas and late-stage R&D in neuro-rare and neuro-specialty diseases.

🚫FDA friction: Capricor Therapeutics has challenged the FDA's rejection of its Duchenne muscular dystrophy cell therapy, deramiocel, arguing that the agency misinterpreted efficacy data from its phase 2 HOPE-2 trial. In a July 16 response to the FDA’s Complete Response Letter (CRL), Capricor asserted that the trial’s primary endpoint was statistically significant when analyzed using a non-parametric test, contrary to the FDA's claim. The biotech also defended its cardiomyopathy data, disputing the FDA’s concerns about the lack of prespecified endpoints and statistical controls. Capricor criticized the agency’s unexpected public release of the CRL and remains hopeful pending upcoming HOPE-3 trial data.

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